Trial Outcomes & Findings for The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus (NCT NCT00700817)
NCT ID: NCT00700817
Last Updated: 2017-03-08
Results Overview
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
665 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2017-03-08
Participant Flow
A total of 158 centres in 13 countries participated: Canada (11), Croatia (3), Germany (12), Ireland (5), Italy (8), Netherlands (8), Romania (4), Serbia (3), Slovakia (6), Slovenia (3), Spain (9), United Kingdom (20) and United States (66). Of the 158 sites approved by an Independent Ethics Committee, 151 actively screened and enrolled subjects.
Between screening and randomisation, eligible subjects were to continue their usual pre-study metformin dose and dosing frequency.
Participant milestones
| Measure |
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Week 0-26 (Main Period)
STARTED
|
225
|
221
|
219
|
0
|
0
|
|
Week 0-26 (Main Period)
Exposed
|
221
|
218
|
219
|
0
|
0
|
|
Week 0-26 (Main Period)
COMPLETED
|
169
|
191
|
194
|
0
|
0
|
|
Week 0-26 (Main Period)
NOT COMPLETED
|
56
|
30
|
25
|
0
|
0
|
|
Week 26-52 (Extension Period 1)
STARTED
|
155
|
176
|
166
|
0
|
0
|
|
Week 26-52 (Extension Period 1)
COMPLETED
|
135
|
150
|
151
|
0
|
0
|
|
Week 26-52 (Extension Period 1)
NOT COMPLETED
|
20
|
26
|
15
|
0
|
0
|
|
Week 52-78 (Extension Period 2)
STARTED
|
134
|
150
|
0
|
67
|
68
|
|
Week 52-78 (Extension Period 2)
COMPLETED
|
124
|
135
|
0
|
59
|
63
|
|
Week 52-78 (Extension Period 2)
NOT COMPLETED
|
10
|
15
|
0
|
8
|
5
|
Reasons for withdrawal
| Measure |
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Week 0-26 (Main Period)
Adverse Event
|
14
|
15
|
4
|
0
|
0
|
|
Week 0-26 (Main Period)
Lack of Efficacy
|
4
|
0
|
4
|
0
|
0
|
|
Week 0-26 (Main Period)
Protocol Violation
|
14
|
4
|
4
|
0
|
0
|
|
Week 0-26 (Main Period)
Withdrawal criteria
|
10
|
7
|
5
|
0
|
0
|
|
Week 0-26 (Main Period)
Unclassified
|
14
|
4
|
8
|
0
|
0
|
|
Week 26-52 (Extension Period 1)
Adverse Event
|
5
|
10
|
3
|
0
|
0
|
|
Week 26-52 (Extension Period 1)
Protocol Violation
|
3
|
2
|
2
|
0
|
0
|
|
Week 26-52 (Extension Period 1)
Lack of Efficacy
|
2
|
3
|
7
|
0
|
0
|
|
Week 26-52 (Extension Period 1)
Withdrawal criteria
|
6
|
8
|
2
|
0
|
0
|
|
Week 26-52 (Extension Period 1)
Unclassified
|
4
|
3
|
1
|
0
|
0
|
|
Week 52-78 (Extension Period 2)
Adverse Event
|
0
|
3
|
0
|
6
|
0
|
|
Week 52-78 (Extension Period 2)
Protocol Violation
|
1
|
2
|
0
|
1
|
1
|
|
Week 52-78 (Extension Period 2)
Lack of Efficacy
|
3
|
3
|
0
|
0
|
0
|
|
Week 52-78 (Extension Period 2)
Withdrawal criteria
|
4
|
3
|
0
|
1
|
3
|
|
Week 52-78 (Extension Period 2)
Unclassified
|
2
|
4
|
0
|
0
|
1
|
Baseline Characteristics
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=225 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=221 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
Total
n=665 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
55.0 years
STANDARD_DEVIATION 9.1 • n=107 Participants
|
55.0 years
STANDARD_DEVIATION 9.0 • n=206 Participants
|
—
|
—
|
55.3 years
STANDARD_DEVIATION 9.2 • n=30 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
—
|
—
|
313 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
—
|
—
|
352 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
—
|
—
|
108 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
186 Participants
n=99 Participants
|
187 Participants
n=107 Participants
|
184 Participants
n=206 Participants
|
—
|
—
|
557 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
—
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
—
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
—
|
11 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
—
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
—
|
—
|
48 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
184 Participants
n=99 Participants
|
193 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
—
|
—
|
576 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
—
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
—
|
—
|
25 Participants
n=30 Participants
|
|
Body Mass Index (BMI) at Screening
|
32.6 kg/m^2
STANDARD_DEVIATION 5.2 • n=99 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 5.1 • n=107 Participants
|
32.6 kg/m^2
STANDARD_DEVIATION 5.4 • n=206 Participants
|
—
|
—
|
32.8 kg/m^2
STANDARD_DEVIATION 5.2 • n=30 Participants
|
|
Duration of Diabetes
|
6.0 years
STANDARD_DEVIATION 4.5 • n=99 Participants
|
6.4 years
STANDARD_DEVIATION 5.4 • n=107 Participants
|
6.3 years
STANDARD_DEVIATION 5.4 • n=206 Participants
|
—
|
—
|
6.2 years
STANDARD_DEVIATION 5.1 • n=30 Participants
|
|
Fasting Plasma Glucose (FPG) at Randomisation
|
10.1 mmol/L
STANDARD_DEVIATION 2.4 • n=99 Participants
|
9.9 mmol/L
STANDARD_DEVIATION 2.4 • n=107 Participants
|
10.0 mmol/L
STANDARD_DEVIATION 2.0 • n=206 Participants
|
—
|
—
|
10.0 mmol/L
STANDARD_DEVIATION 2.3 • n=30 Participants
|
|
Glycosylated Haemoglobin A1c (HbA1c) at Randomisation
|
8.4 Percentage point of total HbA1c
STANDARD_DEVIATION 0.8 • n=99 Participants
|
8.4 Percentage point of total HbA1c
STANDARD_DEVIATION 0.7 • n=107 Participants
|
8.5 Percentage point of total HbA1c
STANDARD_DEVIATION 0.7 • n=206 Participants
|
—
|
—
|
8.4 Percentage point of total HbA1c
STANDARD_DEVIATION 0.8 • n=30 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=210 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=211 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
|
-1.5 Percentage point of total HbA1c
Standard Error 0.06
|
-0.9 Percentage point of total HbA1c
Standard Error 0.07
|
—
|
-1.24 Percentage point of total HbA1c
Standard Error 0.07
|
—
|
PRIMARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=210 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=211 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
|
-1.51 Percentage point of total HbA1c
Standard Error 0.07
|
-0.88 Percentage point of total HbA1c
Standard Error 0.07
|
—
|
-1.29 Percentage point of total HbA1c
Standard Error 0.07
|
—
|
PRIMARY outcome
Timeframe: Week 0, Week 78Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=211 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
|
-1.28 Percentage point of total HbA1c
Standard Error 0.07
|
—
|
—
|
-0.94 Percentage point of total HbA1c
Standard Error 0.08
|
—
|
PRIMARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
|
—
|
—
|
-0.24 Percentage point of total HbA1c
Standard Deviation 0.7
|
—
|
-0.45 Percentage point of total HbA1c
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=218 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
|
55 percentage of subjects
|
22 percentage of subjects
|
—
|
43 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 52
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=210 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=211 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
|
63 percentage of subjects
|
27 percentage of subjects
|
—
|
50 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 78Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the FAS.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=211 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
|
51 percentage of subjects
|
—
|
—
|
35 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the extension 2 FAS.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
|
—
|
—
|
49 percentage of subjects
|
—
|
50 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 26
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=218 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
|
36 percentage of subjects
|
12 percentage of subjects
|
—
|
23 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 52
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=210 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=211 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
|
40 percentage of subjects
|
17 percentage of subjects
|
—
|
24 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 78Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the FAS.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=211 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
|
27 percentage of subjects
|
—
|
—
|
12 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the extension 2 FAS.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
|
—
|
—
|
29 percentage of subjects
|
—
|
25 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in body weight at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=215 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=215 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight at Week 26
|
-3.38 kg
Standard Error 0.27
|
-0.96 kg
Standard Error 0.27
|
—
|
-2.86 kg
Standard Error 0.27
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in body weight at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=215 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=215 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight at Week 52
|
-3.68 kg
Standard Error 0.31
|
-1.16 kg
Standard Error 0.31
|
—
|
-2.78 kg
Standard Error 0.31
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in body weight from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Body Weight From Week 52 to Week 78
|
—
|
—
|
-1.64 kg
Standard Deviation 3
|
—
|
-2.48 kg
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=212 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=210 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=210 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
|
-2.14 mmol/L
Standard Error 0.15
|
-0.83 mmol/L
Standard Error 0.15
|
—
|
-1.87 mmol/L
Standard Error 0.15
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=212 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=209 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=210 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
|
-2.04 mmol/L
Standard Error 0.17
|
-0.59 mmol/L
Standard Error 0.17
|
—
|
-1.71 mmol/L
Standard Error 0.17
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 78Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=212 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=210 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
|
-1.65 mmol/L
Standard Error 0.18
|
—
|
—
|
-1.30 mmol/L
Standard Error 0.18
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=65 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
|
—
|
—
|
-0.84 mmol/L
Standard Deviation 1.8
|
—
|
-1.42 mmol/L
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=208 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=201 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=196 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Beta-cell Function at Week 26
|
28.70 percentage point
Standard Error 3.75
|
4.18 percentage point
Standard Error 3.79
|
—
|
27.23 percentage point
Standard Error 3.82
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=208 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=200 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=196 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Beta-cell Function at Week 52
|
25.76 percentage point
Standard Error 3.25
|
3.98 percentage point
Standard Error 3.30
|
—
|
22.58 percentage point
Standard Error 3.31
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=64 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=64 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Beta-cell Function From Week 52 to Week 78
|
—
|
—
|
13.31 percentage point
Standard Deviation 29.4
|
—
|
23.09 percentage point
Standard Deviation 43.7
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=202 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=201 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=194 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Total Cholesterol at Week 26
|
-0.17 mmol/L
Standard Error 0.05
|
-0.02 mmol/L
Standard Error 0.05
|
—
|
-0.03 mmol/L
Standard Error 0.06
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=203 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=200 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=195 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Total Cholesterol at Week 52
|
-0.09 mmol/L
Standard Error 0.06
|
0.03 mmol/L
Standard Error 0.06
|
—
|
-0.01 mmol/L
Standard Error 0.06
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in total cholesterol from Week 52 to Week 78
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=65 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Total Cholesterol From Week 52 to Week 78
|
—
|
—
|
-0.16 mmol/L
Standard Deviation 0.8
|
—
|
-0.24 mmol/L
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=202 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=200 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=194 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
|
0.05 mmol/L
Standard Error 0.05
|
0.13 mmol/L
Standard Error 0.05
|
—
|
0.08 mmol/L
Standard Error 0.05
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=203 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=199 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=195 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
|
0.09 mmol/L
Standard Error 0.05
|
0.17 mmol/L
Standard Error 0.05
|
—
|
0.09 mmol/L
Standard Error 0.05
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=65 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
|
—
|
—
|
-0.22 mmol/L
Standard Deviation 0.7
|
—
|
-0.25 mmol/L
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=201 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=201 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=194 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
|
0.00 mmol/L
Standard Error 0.01
|
0.00 mmol/L
Standard Error 0.01
|
—
|
0.00 mmol/L
Standard Error 0.01
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=202 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=200 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=195 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
|
0.02 mmol/L
Standard Error 0.01
|
0.01 mmol/L
Standard Error 0.01
|
—
|
0.01 mmol/L
Standard Error 0.01
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=65 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
|
—
|
—
|
0.02 mmol/L
Standard Deviation 0.1
|
—
|
-0.01 mmol/L
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=201 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=199 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=194 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
|
-0.20 mmol/L
Standard Error 0.03
|
-0.15 mmol/L
Standard Error 0.03
|
—
|
-0.11 mmol/L
Standard Error 0.03
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=202 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=198 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=195 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
|
-0.19 mmol/L
Standard Error 0.04
|
-0.15 mmol/L
Standard Error 0.04
|
—
|
-0.11 mmol/L
Standard Error 0.04
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=65 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
|
—
|
—
|
0.03 mmol/L
Standard Deviation 0.3
|
—
|
0.02 mmol/L
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=199 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=198 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=191 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Triglycerides (TG) at Week 26
|
-0.43 mmol/L
Standard Error 0.09
|
-0.40 mmol/L
Standard Error 0.09
|
—
|
-0.19 mmol/L
Standard Error 0.10
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=200 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=197 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=194 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Triglycerides (TG) at Week 52
|
-0.32 mmol/L
Standard Error 0.10
|
-0.23 mmol/L
Standard Error 0.10
|
—
|
-0.10 mmol/L
Standard Error 0.10
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in triglycerides (TG) from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=64 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=66 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Triglycerides (TG) From Week 52 to Week 78
|
—
|
—
|
-0.20 mmol/L
Standard Deviation 0.8
|
—
|
-0.26 mmol/L
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=149 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=158 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=147 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
|
-0.07 mmol/L
Standard Error 0.02
|
-0.05 mmol/L
Standard Error 0.02
|
—
|
-0.03 mmol/L
Standard Error 0.02
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=177 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=176 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=170 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
|
-0.10 mmol/L
Standard Error 0.02
|
-0.06 mmol/L
Standard Error 0.02
|
—
|
-0.07 mmol/L
Standard Error 0.02
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in free fatty acids (FFA) from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=60 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=65 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
|
—
|
—
|
0.02 mmol/L
Standard Deviation 0.3
|
—
|
-0.01 mmol/L
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=175 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=182 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=164 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Apolipoprotein B at Week 26
|
-0.07 g/L
Standard Error 0.01
|
-0.05 g/L
Standard Error 0.01
|
—
|
-0.06 g/L
Standard Error 0.01
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=192 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=195 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=184 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Apolipoprotein B at Week 52
|
-0.03 g/L
Standard Error 0.01
|
-0.03 g/L
Standard Error 0.01
|
—
|
-0.03 g/L
Standard Error 0.01
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=66 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Apolipoprotein B From Week 52 to Week 78
|
—
|
—
|
0.23 mmol/L
Standard Deviation 0.4
|
—
|
0.17 mmol/L
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=209 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=205 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=205 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
|
-0.99 mg/L
Standard Error 0.31
|
-0.66 mg/L
Standard Error 0.31
|
—
|
-1.02 mg/L
Standard Error 0.31
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=198 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=182 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=188 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
|
-561 U/L
Standard Error 941.1
|
586 U/L
Standard Error 952
|
—
|
-833 U/L
Standard Error 945.1
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=210 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=206 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=204 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
|
1.71 pg/mL
Standard Error 2.47
|
0.91 pg/mL
Standard Error 2.49
|
—
|
-1.70 pg/mL
Standard Error 2.49
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=209 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=205 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=204 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
|
3.74 pmol/L
Standard Error 2.06
|
3.71 pmol/L
Standard Error 2.07
|
—
|
5.19 pmol/L
Standard Error 2.07
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=210 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=207 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=202 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Adiponectin at Week 26.
|
1.51 mcg/mL
Standard Error 0.19
|
1.35 mcg/mL
Standard Error 0.19
|
—
|
1.69 mcg/mL
Standard Error 0.19
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=204 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=196 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=195 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
|
-0.74 pg/mL
Standard Error 0.25
|
-0.53 pg/mL
Standard Error 0.25
|
—
|
-0.55 pg/mL
Standard Error 0.25
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=193 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=183 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=189 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
|
-4.34 percentage point
Standard Error 2.76
|
-1.8 percentage point
Standard Error 2.82
|
—
|
-1.73 percentage point
Standard Error 2.77
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=208 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=207 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=210 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Waist to Hip Ratio at Week 26.
|
-0.01 cm/cm
Standard Error 0.00
|
-0.00 cm/cm
Standard Error 0.00
|
—
|
-0.01 cm/cm
Standard Error 0.00
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=208 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=207 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=210 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Waist to Hip Ratio at Week 52
|
-0.01 cm/cm
Standard Error 0.00
|
-0.00 cm/cm
Standard Error 0.00
|
—
|
-0.00 cm/cm
Standard Error 0.00
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=66 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Waist to Hip Ratio From Week 52 to Week 78
|
—
|
—
|
-0.01 cm/cm
Standard Deviation 0
|
—
|
-0.00 cm/cm
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=208 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=208 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=210 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Waist Circumference at Week 26.
|
-2.63 cm
Standard Error 0.36
|
-1.12 cm
Standard Error 0.36
|
—
|
-2.69 cm
Standard Error 0.35
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=208 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=208 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=210 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Waist Circumference at Week 52
|
-3.02 participants
Standard Error 0.38
|
-1.23 participants
Standard Error 0.38
|
—
|
-2.36 participants
Standard Error 0.38
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in Waist Circumference from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=66 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Waist Circumference From Week 52 to Week 78
|
—
|
—
|
-1.33 kg
Standard Deviation 3.5
|
—
|
-2.05 kg
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=213 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=213 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
|
-0.72 mmHg
Standard Error 0.89
|
-0.94 mmHg
Standard Error 0.89
|
—
|
-0.55 mmHg
Standard Error 0.89
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=213 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=213 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
|
-2.55 mmHg
Standard Error 0.93
|
-1.03 mmHg
Standard Error 0.93
|
—
|
-0.37 mmHg
Standard Error 0.93
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
|
—
|
—
|
-2.12 mmHg
Standard Deviation 14.6
|
—
|
0.35 mmHg
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=213 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=213 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
|
0.07 mmHg
Standard Error 0.59
|
-1.78 mmHg
Standard Error 0.60
|
—
|
-0.71 mmHg
Standard Error 0.60
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=213 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=213 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
|
-0.87 mmHg
Standard Error 0.57
|
-1.47 mmHg
Standard Error 0.57
|
—
|
-0.53 mmHg
Standard Error 0.57
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
|
—
|
—
|
-0.60 mmHg
Standard Deviation 10.0
|
—
|
0.03 mmHg
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in pulse at Week 26.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=211 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=212 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Pulse at Week 26
|
3.94 beats/minute
Standard Error 0.58
|
-0.64 beats/minute
Standard Error 0.59
|
—
|
2.32 beats/minute
Standard Error 0.59
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Calculated as an estimate of the mean change from baseline in pulse at Week 52.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=214 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=211 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=212 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Pulse at Week 52
|
3.09 mmHg
Standard Error 0.60
|
0.09 mmHg
Standard Error 0.60
|
—
|
1.72 mmHg
Standard Error 0.60
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Mean change in pulse from Week 52 to Week 78.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Pulse From Week 52 to Week 78
|
—
|
—
|
0.90 beats/minute
Standard Deviation 8.4
|
—
|
2.19 beats/minute
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Week 0, Week 26Population: Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=171 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=170 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=164 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
|
4.35 scores on a scale
Standard Error 0.48
|
2.96 scores on a scale
Standard Error 0.48
|
—
|
3.51 scores on a scale
Standard Error 0.49
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=165 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=169 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=163 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
|
4.31 scores on a scale
Standard Error 0.48
|
2.96 scores on a scale
Standard Error 0.48
|
—
|
3.32 scores on a scale
Standard Error 0.49
|
—
|
SECONDARY outcome
Timeframe: Week 52, Week 78Population: Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=54 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=48 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78
|
—
|
—
|
1.48 scores on a scale
Standard Deviation 4.4
|
—
|
0.98 scores on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=218 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Hypoglyceamic Episodes, Weeks 0-26
Major
|
0 episodes
|
0 episodes
|
—
|
1 episodes
|
—
|
|
Hypoglyceamic Episodes, Weeks 0-26
Minor
|
37 episodes
|
11 episodes
|
—
|
17 episodes
|
—
|
|
Hypoglyceamic Episodes, Weeks 0-26
Symptoms only
|
15 episodes
|
10 episodes
|
—
|
12 episodes
|
—
|
|
Hypoglyceamic Episodes, Weeks 0-26
Unclassified
|
1 episodes
|
0 episodes
|
—
|
0 episodes
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-26Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=217 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Symptoms only
|
15 episodes
|
10 episodes
|
—
|
12 episodes
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Major
|
0 episodes
|
0 episodes
|
—
|
1 episodes
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Minor
|
16 episodes
|
11 episodes
|
—
|
17 episodes
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Unclassified
|
1 episodes
|
0 episodes
|
—
|
0 episodes
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-52Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=218 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Hypoglyceamic Episodes, Weeks 0-52
Major
|
0 episodes
|
0 episodes
|
—
|
1 episodes
|
—
|
|
Hypoglyceamic Episodes, Weeks 0-52
Minor
|
51 episodes
|
25 episodes
|
—
|
24 episodes
|
—
|
|
Hypoglyceamic Episodes, Weeks 0-52
Symptoms only
|
29 episodes
|
12 episodes
|
—
|
14 episodes
|
—
|
|
Hypoglyceamic Episodes, Weeks 0-52
Unclassified
|
1 episodes
|
0 episodes
|
—
|
0 episodes
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-52Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=218 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
Major
|
0 episodes
|
0 episodes
|
—
|
1 episodes
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
Minor
|
28 episodes
|
25 episodes
|
—
|
24 episodes
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
Symptoms only
|
29 episodes
|
12 episodes
|
—
|
14 episodes
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
Unclassified
|
1 episodes
|
0 episodes
|
—
|
0 episodes
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-78Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=218 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Hypoglyceamic Episodes, Weeks 0-78
Major
|
0 episodes
|
0 episodes
|
—
|
2 episodes
|
—
|
|
Hypoglyceamic Episodes, Weeks 0-78
Minor
|
56 episodes
|
34 episodes
|
—
|
36 episodes
|
—
|
|
Hypoglyceamic Episodes, Weeks 0-78
Symptoms only
|
40 episodes
|
13 episodes
|
—
|
18 episodes
|
—
|
|
Hypoglyceamic Episodes, Weeks 0-78
Unclassified
|
1 episodes
|
0 episodes
|
—
|
0 episodes
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-78Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=218 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
Major
|
0 episodes
|
0 episodes
|
—
|
2 episodes
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
Minor
|
33 episodes
|
34 episodes
|
—
|
36 episodes
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
Unclassified
|
1 episodes
|
0 episodes
|
—
|
0 episodes
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
Symptoms only
|
40 episodes
|
13 episodes
|
—
|
18 episodes
|
—
|
SECONDARY outcome
Timeframe: Week 52-78Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Outcome measures
| Measure |
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=150 Participants
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
Sita -> Sita -> Lira 1.2 mg
n=67 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
|
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=134 Participants
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita -> Lira 1.8 mg
n=68 Participants
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
|
|---|---|---|---|---|---|
|
Hypoglycaamic Episodes, Weeks 52-78
Major
|
0 episodes
|
—
|
0 episodes
|
1 episodes
|
0 episodes
|
|
Hypoglycaamic Episodes, Weeks 52-78
Unclassified
|
0 episodes
|
—
|
0 episodes
|
0 episodes
|
0 episodes
|
|
Hypoglycaamic Episodes, Weeks 52-78
Minor
|
5 episodes
|
—
|
3 episodes
|
12 episodes
|
6 episodes
|
|
Hypoglycaamic Episodes, Weeks 52-78
Symptoms only
|
11 episodes
|
—
|
1 episodes
|
3 episodes
|
0 episodes
|
Adverse Events
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Serious events: 12 serious events
Other events: 120 other events
Deaths: 0 deaths
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Serious events: 19 serious events
Other events: 134 other events
Deaths: 0 deaths
Sita -> Sita
Serious events: 17 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 participants at risk
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=218 participants at risk
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 participants at risk
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.92%
2/218 • Number of events 2 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Eye disorders
Papilloedema
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
General disorders
Non-cardiac chest pain
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Mycetoma mycotic
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Infected sebaceous cyst
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epiglottic carcinoma
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Endocrine disorders
Thyroid disorder
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.90%
2/221 • Number of events 2 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Nervous system disorders
Hypoaesthesia
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Abcess Limb
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Cholecytitis infective
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Sepsis
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal adenoma
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Cardiac disorders
Myocardial infarction
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Haematochezia
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 2 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Injury, poisoning and procedural complications
Fall
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoe syndrome
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/218 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Congenital, familial and genetic disorders
Hereditary haemorrhagic telangiectasia
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
General disorders
Hypothermia
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/221 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.46%
1/219 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Vascular disorders
Hypertensive crisis
|
0.45%
1/221 • Number of events 1 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/218 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
0.00%
0/219 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
Other adverse events
| Measure |
Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
n=221 participants at risk
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
n=218 participants at risk
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
|
Sita -> Sita
n=219 participants at risk
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
21.7%
48/221 • Number of events 60 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
28.0%
61/218 • Number of events 73 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
16.4%
36/219 • Number of events 45 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
21/221 • Number of events 30 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
13.3%
29/218 • Number of events 52 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
11.0%
24/219 • Number of events 40 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
18/221 • Number of events 27 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
11.0%
24/218 • Number of events 28 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
6.8%
15/219 • Number of events 21 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
8/221 • Number of events 9 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
7.8%
17/218 • Number of events 23 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
5.0%
11/219 • Number of events 17 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
10/221 • Number of events 11 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
6.4%
14/218 • Number of events 16 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
4.6%
10/219 • Number of events 11 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Nasopharyngitis
|
14.9%
33/221 • Number of events 42 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
16.5%
36/218 • Number of events 52 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
14.6%
32/219 • Number of events 50 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Influenza
|
6.3%
14/221 • Number of events 17 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
3.2%
7/218 • Number of events 7 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
4.1%
9/219 • Number of events 13 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Nervous system disorders
Headache
|
10.4%
23/221 • Number of events 36 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
14.2%
31/218 • Number of events 56 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
15.1%
33/219 • Number of events 50 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
8/221 • Number of events 8 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
5.5%
12/218 • Number of events 12 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
4.1%
9/219 • Number of events 9 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
General disorders
Fatigue
|
4.1%
9/221 • Number of events 9 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
6.0%
13/218 • Number of events 14 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
2.3%
5/219 • Number of events 5 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
16/221 • Number of events 27 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
5.0%
11/218 • Number of events 16 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
6.4%
14/219 • Number of events 20 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Investigations
Blood calcitonin increased
|
4.1%
9/221 • Number of events 9 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
5.0%
11/218 • Number of events 14 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
2.7%
6/219 • Number of events 7 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
13/221 • Number of events 21 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
6.4%
14/218 • Number of events 16 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
5.9%
13/219 • Number of events 16 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Nervous system disorders
Dizziness
|
4.5%
10/221 • Number of events 10 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
6.4%
14/218 • Number of events 19 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
3.7%
8/219 • Number of events 8 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
|
Vascular disorders
Hypertension
|
5.9%
13/221 • Number of events 13 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
6.4%
14/218 • Number of events 14 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
3.2%
7/219 • Number of events 8 • The adverse events were collected in a timeframe of 78 weeks.
The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER