Trial Outcomes & Findings for The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes (NCT NCT00856986)
NCT ID: NCT00856986
Last Updated: 2017-03-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
987 participants
Primary outcome timeframe
Week 0 (Randomisation), week 26
Results posted on
2017-03-08
Participant Flow
A total of 202 centres in 9 countries: Belgium (2), Canada (7), France (19), Germany (37), Italy (18), the Netherlands (16), Spain (14), the United Kingdom (32) and the United States (57)
Subjects on metformin and/or sulpholynurea treatment underwent a 12-week run-in period with liraglutide + metformin. Subjects not achieving an HbA1c below 7% were randomised to liraglutide + metformin treatment with/without insulin detemir. Subjects achieving an HbA1c below 7% continued liraglutide + metformin treatment.
Participant milestones
| Measure |
Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Run-in Period, Weeks -12-0
STARTED
|
161
|
162
|
498
|
167
|
0
|
|
Run-in Period, Weeks -12-0
COMPLETED
|
161
|
162
|
498
|
0
|
0
|
|
Run-in Period, Weeks -12-0
NOT COMPLETED
|
0
|
0
|
0
|
167
|
0
|
|
Main Period, Weeks 0-26
STARTED
|
161
|
162
|
498
|
0
|
0
|
|
Main Period, Weeks 0-26
COMPLETED
|
127
|
144
|
470
|
0
|
0
|
|
Main Period, Weeks 0-26
NOT COMPLETED
|
34
|
18
|
28
|
0
|
0
|
|
Extension Period, Weeks 26-52
STARTED
|
127
|
144
|
470
|
0
|
0
|
|
Extension Period, Weeks 26-52
Enrolled in Extension
|
122
|
140
|
461
|
0
|
0
|
|
Extension Period, Weeks 26-52
COMPLETED
|
108
|
130
|
432
|
0
|
0
|
|
Extension Period, Weeks 26-52
NOT COMPLETED
|
19
|
14
|
38
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Extension Period, Weeks 26-52
Protocol Violation
|
6
|
2
|
5
|
0
|
0
|
|
Run-in Period, Weeks -12-0
Adverse Event
|
0
|
0
|
0
|
92
|
0
|
|
Run-in Period, Weeks -12-0
Protocol Violation
|
0
|
0
|
0
|
24
|
0
|
|
Run-in Period, Weeks -12-0
Withdrawal Criteria
|
0
|
0
|
0
|
10
|
0
|
|
Run-in Period, Weeks -12-0
Lost to Follow-up
|
0
|
0
|
0
|
11
|
0
|
|
Run-in Period, Weeks -12-0
Lack of Efficacy
|
0
|
0
|
0
|
6
|
0
|
|
Run-in Period, Weeks -12-0
Unclassified
|
0
|
0
|
0
|
24
|
0
|
|
Main Period, Weeks 0-26
Adverse Event
|
6
|
4
|
9
|
0
|
0
|
|
Main Period, Weeks 0-26
Protocol Violation
|
4
|
5
|
7
|
0
|
0
|
|
Main Period, Weeks 0-26
Withdrawal Criteria
|
11
|
0
|
3
|
0
|
0
|
|
Main Period, Weeks 0-26
Lost to Follow-up
|
1
|
1
|
2
|
0
|
0
|
|
Main Period, Weeks 0-26
Lack of Efficacy
|
5
|
2
|
0
|
0
|
0
|
|
Main Period, Weeks 0-26
Unclassified
|
7
|
6
|
7
|
0
|
0
|
|
Extension Period, Weeks 26-52
Adverse Event
|
3
|
3
|
10
|
0
|
0
|
|
Extension Period, Weeks 26-52
Withdrawal Criteria
|
2
|
0
|
8
|
0
|
0
|
|
Extension Period, Weeks 26-52
Lost to Follow-up
|
0
|
5
|
2
|
0
|
0
|
|
Extension Period, Weeks 26-52
Lack of Efficacy
|
4
|
2
|
2
|
0
|
0
|
|
Extension Period, Weeks 26-52
Unclassified
|
4
|
2
|
11
|
0
|
0
|
Baseline Characteristics
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Lira 1.8
n=161 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=162 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
n=498 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
n=166 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
n=24 Participants
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
Total
n=1011 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 9.8 • n=39 Participants
|
57 years
STANDARD_DEVIATION 9.5 • n=41 Participants
|
56.7 years
STANDARD_DEVIATION 9.7 • n=35 Participants
|
58.7 years
STANDARD_DEVIATION 10.8 • n=31 Participants
|
54.3 years
STANDARD_DEVIATION 10.3 • n=146 Participants
|
56.9 years
STANDARD_DEVIATION 9.7 • n=19 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=39 Participants
|
74 Participants
n=41 Participants
|
216 Participants
n=35 Participants
|
75 Participants
n=31 Participants
|
11 Participants
n=146 Participants
|
448 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=39 Participants
|
88 Participants
n=41 Participants
|
282 Participants
n=35 Participants
|
91 Participants
n=31 Participants
|
13 Participants
n=146 Participants
|
563 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
28 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
128 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
136 Participants
n=39 Participants
|
140 Participants
n=41 Participants
|
450 Participants
n=35 Participants
|
138 Participants
n=31 Participants
|
19 Participants
n=146 Participants
|
883 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
14 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
56 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
141 Participants
n=39 Participants
|
144 Participants
n=41 Participants
|
470 Participants
n=35 Participants
|
146 Participants
n=31 Participants
|
22 Participants
n=146 Participants
|
923 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
16 Participants
n=19 Participants
|
|
Height
|
1.7 meter
STANDARD_DEVIATION 0.1 • n=39 Participants
|
1.69 meter
STANDARD_DEVIATION 0.11 • n=41 Participants
|
1.7 meter
STANDARD_DEVIATION 0.1 • n=35 Participants
|
1.68 meter
STANDARD_DEVIATION 0.1 • n=31 Participants
|
1.72 meter
STANDARD_DEVIATION 0.09 • n=146 Participants
|
1.69 meter
STANDARD_DEVIATION 0.1 • n=19 Participants
|
|
Body weight
|
98.6 kg
STANDARD_DEVIATION 21.3 • n=39 Participants
|
99.5 kg
STANDARD_DEVIATION 21.2 • n=41 Participants
|
99 kg
STANDARD_DEVIATION 20.8 • n=35 Participants
|
90.2 kg
STANDARD_DEVIATION 18.5 • n=31 Participants
|
109 kg
STANDARD_DEVIATION 25.7 • n=146 Participants
|
99 kg
STANDARD_DEVIATION 21 • n=19 Participants
|
|
Body Mass Index (BMI)
|
33.9 kg/m^2
STANDARD_DEVIATION 6 • n=39 Participants
|
34.9 kg/m^2
STANDARD_DEVIATION 6.3 • n=41 Participants
|
34.4 kg/m^2
STANDARD_DEVIATION 6.7 • n=35 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 6 • n=31 Participants
|
36.5 kg/m^2
STANDARD_DEVIATION 7.7 • n=146 Participants
|
34.4 kg/m^2
STANDARD_DEVIATION 6.5 • n=19 Participants
|
|
Diabetes History
|
8.5 years
STANDARD_DEVIATION 6 • n=39 Participants
|
8.6 years
STANDARD_DEVIATION 5.8 • n=41 Participants
|
6.6 years
STANDARD_DEVIATION 5.7 • n=35 Participants
|
8.4 years
STANDARD_DEVIATION 6.4 • n=31 Participants
|
6.8 years
STANDARD_DEVIATION 5.4 • n=146 Participants
|
7.4 years
STANDARD_DEVIATION 5.8 • n=19 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.3 Percentage point of total HbA1c
STANDARD_DEVIATION 0.8 • n=39 Participants
|
8.2 Percentage point of total HbA1c
STANDARD_DEVIATION 0.7 • n=41 Participants
|
7.7 Percentage point of total HbA1c
STANDARD_DEVIATION 0.7 • n=35 Participants
|
8 Percentage point of total HbA1c
STANDARD_DEVIATION 0.8 • n=31 Participants
|
8.4 Percentage point of total HbA1c
STANDARD_DEVIATION 0.7 • n=146 Participants
|
7.9 Percentage point of total HbA1c
STANDARD_DEVIATION 0.8 • n=19 Participants
|
|
Fasting plasma glucose (FPG)
|
10.3 mmol/L
STANDARD_DEVIATION 2.5 • n=39 Participants
|
10.2 mmol/L
STANDARD_DEVIATION 2.4 • n=41 Participants
|
9.2 mmol/L
STANDARD_DEVIATION 1.8 • n=35 Participants
|
9.5 mmol/L
STANDARD_DEVIATION 3 • n=31 Participants
|
10.4 mmol/L
STANDARD_DEVIATION 2.3 • n=146 Participants
|
9.6 mmol/L
STANDARD_DEVIATION 2.1 • n=19 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Randomisation), week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=149 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.
|
0.02 Percentage point of total HbA1c
Standard Error 0.07
|
-0.51 Percentage point of total HbA1c
Standard Error 0.07
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=149 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)
|
-0.1 Percentage point of total HbA1c
Standard Error 0.09
|
-0.51 Percentage point of total HbA1c
Standard Error 0.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) includes LOCF of last observation before intensification for randomised Lira 1.8 mg treatment group subjects who were intensified.
Outcome measures
| Measure |
Lira 1.8
n=149 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)
|
0.01 Percentage point of total HbA1c
Standard Error 0.09
|
-0.5 Percentage point of total HbA1c
Standard Error 0.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=154 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Fasting Plasma Glucose at Week 26
|
-0.39 mmol/L
Standard Error 0.19
|
-2.12 mmol/L
Standard Error 0.19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=154 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Fasting Plasma Glucose at Week 52
|
-0.14 mmol/L
Standard Error 0.21
|
-1.91 mmol/L
Standard Error 0.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.
Outcome measures
| Measure |
Lira 1.8
n=133 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=144 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
Change at Breakfast, N=133, 144
|
-0.97 mmol/L
Standard Error 0.26
|
-2.09 mmol/L
Standard Error 0.26
|
—
|
—
|
—
|
|
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
Change at Lunch, N= 134, 143
|
-0.83 mmol/L
Standard Error 0.22
|
-1.43 mmol/L
Standard Error 0.22
|
—
|
—
|
—
|
|
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
Change at Dinner, N= 133, 139
|
-0.48 mmol/L
Standard Error 0.24
|
-1.18 mmol/L
Standard Error 0.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.
Outcome measures
| Measure |
Lira 1.8
n=136 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=148 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52
Change at Breakfast, N=148, 135
|
-0.68 mmol/L
Standard Error 0.25
|
-2.43 mmol/L
Standard Error 0.25
|
—
|
—
|
—
|
|
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52
Change at Lunch, N= 145, 136
|
-0.51 mmol/L
Standard Error 0.25
|
-1.14 mmol/L
Standard Error 0.25
|
—
|
—
|
—
|
|
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52
Change at Dinner, N= 144, 135
|
-0.96 mmol/L
Standard Error 0.26
|
-1.4 mmol/L
Standard Error 0.25
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 52Population: Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=135 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=152 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Fasting Pro-insulin at Week 26.
|
-1.12 pmol/L
Standard Error 3.27
|
-9.78 pmol/L
Standard Error 3.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=139 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=152 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Fasting Pro-insulin at Week 52
|
1.47 pmol/L
Standard Error 3.08
|
-4 pmol/L
Standard Error 3.08
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=136 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=149 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Fasting C-peptide at Week 26.
|
-0.08 mmol/L
Standard Error 0.04
|
-0.32 mmol/L
Standard Error 0.04
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=139 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=150 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Fasting C-peptide at Week 52.
|
0.02 mmol/L
Standard Error 0.05
|
-0.34 mmol/L
Standard Error 0.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)
Outcome measures
| Measure |
Lira 1.8
n=141 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=152 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
Change in VLDL-C
|
0.05 mmol/L
Standard Error 0.03
|
0.01 mmol/L
Standard Error 0.03
|
—
|
—
|
—
|
|
Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
Change in Total Cholesterol
|
0.04 mmol/L
Standard Error 0.07
|
0.05 mmol/L
Standard Error 0.07
|
—
|
—
|
—
|
|
Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
Change in LDL-C
|
-0.04 mmol/L
Standard Error 0.06
|
-0.03 mmol/L
Standard Error 0.06
|
—
|
—
|
—
|
|
Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
Change in HDL-C
|
0.02 mmol/L
Standard Error 0.01
|
0.05 mmol/L
Standard Error 0.01
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)
Outcome measures
| Measure |
Lira 1.8
n=141 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=153 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
Change in Total Cholesterol
|
-0.02 mmol/L
Standard Error 0.08
|
-0.03 mmol/L
Standard Error 0.08
|
—
|
—
|
—
|
|
Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
Change in LDL-C
|
-0.08 mmol/L
Standard Error 0.07
|
-0.1 mmol/L
Standard Error 0.07
|
—
|
—
|
—
|
|
Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
Change in VLDL-C
|
0.03 mmol/L
Standard Error 0.04
|
-0.03 mmol/L
Standard Error 0.04
|
—
|
—
|
—
|
|
Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
Change in HDL-C
|
0.02 mmol/L
Standard Error 0.02
|
0.07 mmol/L
Standard Error 0.02
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=141 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=151 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Lipids: Triglycerides at Week 26
|
-0.24 mmol/L
Standard Error 0.11
|
-0.33 mmol/L
Standard Error 0.11
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=141 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=152 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Lipids: Triglycerides at Week 52
|
-0.22 mmol/L
Standard Error 0.11
|
-0.37 mmol/L
Standard Error 0.11
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=131 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=140 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26
|
-0.03 mmol/L
Standard Error 0.02
|
-0.11 mmol/L
Standard Error 0.02
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=133 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=141 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52
|
-0.03 mmol/L
Standard Error 0.03
|
-0.07 mmol/L
Standard Error 0.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=157 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=162 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Body Weight at Week 26
|
-0.95 kg
Standard Error 0.31
|
-0.16 kg
Standard Error 0.31
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (last observation carried forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=157 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=162 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Body Weight at Week 52
|
-1.02 kg
Standard Error 0.41
|
-0.05 kg
Standard Error 0.42
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=148 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Waist Circumference at Week 26.
|
-0.66 cm
Standard Error 0.46
|
-0.78 cm
Standard Error 0.46
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=148 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Waist Circumference at Week 52.
|
-0.83 participants
Standard Error 0.54
|
-0.83 participants
Standard Error 0.53
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=148 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Hip Circumference at Week 26
|
-0.36 cm
Standard Error 0.46
|
-0.38 cm
Standard Error 0.45
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=148 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Hip Circumference at Week 52
|
-0.79 cm
Standard Error 0.5
|
-0.28 cm
Standard Error 0.49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference
Outcome measures
| Measure |
Lira 1.8
n=148 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Waist to Hip Ratio at Week 26
|
-0.00356 cm/cm
Standard Error 0.004071
|
-0.00332 cm/cm
Standard Error 0.004032
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference
Outcome measures
| Measure |
Lira 1.8
n=148 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=160 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Waist to Hip Ratio at Week 52
|
-0.00146 cm/cm
Standard Error 0.004165
|
-0.00438 cm/cm
Standard Error 0.004126
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Randomisation), Week 26Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=157 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=162 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.
Systolic Blood Pressure
|
1.11 mmHg
Standard Error 1.22
|
0.41 mmHg
Standard Error 1.23
|
—
|
—
|
—
|
|
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.
Diastolic Blood Pressure
|
-1.1 mmHg
Standard Error 0.77
|
-0.4 mmHg
Standard Error 0.78
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Outcome measures
| Measure |
Lira 1.8
n=157 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=162 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.
Diastolic Blood Pressure
|
-0.66 mmHg
Standard Error 0.78
|
0.11 mmHg
Standard Error 0.79
|
—
|
—
|
—
|
|
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.
Systolic Blood Pressure
|
-0.74 mmHg
Standard Error 1.2
|
0.16 mmHg
Standard Error 1.21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Run-in (week -12) to Week 52Population: The Safety Analysis Set included all exposed subjects
Outcome measures
| Measure |
Lira 1.8
n=159 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=163 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
n=499 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
n=166 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
n=24 Participants
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Adverse Events From Run-in (Week -12) to Week 52
|
716 events
|
845 events
|
2389 events
|
383 events
|
30 events
|
SECONDARY outcome
Timeframe: weeks 0-26Population: The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only 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
n=158 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=163 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
n=499 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Major
|
0 episodes
|
0 episodes
|
0 episodes
|
—
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Minor
|
2 episodes
|
22 episodes
|
31 episodes
|
—
|
—
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Symptoms only
|
9 episodes
|
19 episodes
|
26 episodes
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0-52Population: The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only 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
n=159 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=163 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
n=499 Participants
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
n=24 Participants
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Hypoglycaemic Episodes Weeks 0-52
Major
|
0 episodes
|
0 episodes
|
0 episodes
|
—
|
0 episodes
|
|
Hypoglycaemic Episodes Weeks 0-52
Minor
|
4 episodes
|
33 episodes
|
53 episodes
|
—
|
1 episodes
|
|
Hypoglycaemic Episodes Weeks 0-52
Symptoms only
|
14 episodes
|
57 episodes
|
42 episodes
|
—
|
2 episodes
|
|
Hypoglycaemic Episodes Weeks 0-52
Unknown
|
0 episodes
|
1 episodes
|
2 episodes
|
—
|
0 episodes
|
Adverse Events
Lira 1.8
Serious events: 11 serious events
Other events: 100 other events
Deaths: 0 deaths
Insulin Detemir + Lira 1.8
Serious events: 17 serious events
Other events: 102 other events
Deaths: 0 deaths
Non-Randomised Lira 1.8
Serious events: 62 serious events
Other events: 310 other events
Deaths: 0 deaths
Early Withdrawals Lira 1.8
Serious events: 6 serious events
Other events: 122 other events
Deaths: 0 deaths
Intensified Group
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lira 1.8
n=159 participants at risk
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=163 participants at risk
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
n=499 participants at risk
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
n=166 participants at risk
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
n=24 participants at risk
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.40%
2/499 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Traumatic Intracranial Haemorrhage
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Abdominal Hernia Obstructive
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Intestinal Infarction
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Helicobacter Gastritis
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Post Procedural Infection
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Viral Infection
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Musculoskeletal and connective tissue disorders
Interverterbal Disc Degeneration
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Musculoskeletal and connective tissue disorders
Interverterbal Disc Protrusion
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.40%
2/499 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Nervous system disorders
Convulsion
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Nervous system disorders
Benign Intracranial Hypertension
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Nervous system disorders
Syncope
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.40%
2/499 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.40%
2/499 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Psychiatric disorders
Depression
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
1.2%
2/163 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.60%
1/166 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary Disease
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Deviation
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Cardiac disorders
Angina Pectoris
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.60%
1/166 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.80%
4/499 • Number of events 4 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 5 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Eye disorders
Macular Ischaemia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Eye disorders
Macular Oedema
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
General disorders
Chest Pain
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.60%
1/166 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
4.2%
1/24 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.60%
1/166 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Cellulitis
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Muscle abscess
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Pneumonia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.40%
2/499 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.60%
1/166 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.40%
2/499 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Nervous system disorders
Partial Seizures
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Renal and urinary disorders
Renal failure acute
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Reproductive system and breast disorders
Fibrocystic Breast Disease
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Unspecified
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of Breast
|
—
0/0 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.61%
1/163 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Cardiac disorders
Cardiac failure
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Vascular disorders
Poor Peripheral Circulation
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Endocrine disorders
Goitre
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Endocrine disorders
Thyroid ccell hyperplasia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Investigations
ECG abnormal
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Investigations
ECG change
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.20%
1/499 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Surgical and medical procedures
Medical device removal
|
0.63%
1/159 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/159 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/163 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/499 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.60%
1/166 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
Other adverse events
| Measure |
Lira 1.8
n=159 participants at risk
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Insulin Detemir + Lira 1.8
n=163 participants at risk
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
|
Non-Randomised Lira 1.8
n=499 participants at risk
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
|
Early Withdrawals Lira 1.8
n=166 participants at risk
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
|
Intensified Group
n=24 participants at risk
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
25.2%
40/159 • Number of events 57 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
20.2%
33/163 • Number of events 45 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
14.4%
72/499 • Number of events 97 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
1.2%
2/166 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
12.5%
3/24 • Number of events 3 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Diarrhoea
|
16.4%
26/159 • Number of events 29 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
17.8%
29/163 • Number of events 42 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
14.8%
74/499 • Number of events 108 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
12.7%
21/166 • Number of events 25 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
4.2%
1/24 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Nausea
|
23.3%
37/159 • Number of events 51 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
18.4%
30/163 • Number of events 40 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
27.3%
136/499 • Number of events 204 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
39.8%
66/166 • Number of events 72 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
4.2%
1/24 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Investigations
Lipase Increased
|
10.1%
16/159 • Number of events 17 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
16.0%
26/163 • Number of events 27 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
11.0%
55/499 • Number of events 60 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
3.6%
6/166 • Number of events 7 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
16.7%
4/24 • Number of events 4 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Nervous system disorders
Headache
|
14.5%
23/159 • Number of events 41 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
12.9%
21/163 • Number of events 54 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
14.6%
73/499 • Number of events 144 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
7.8%
13/166 • Number of events 22 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
8.3%
2/24 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
19/159 • Number of events 21 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
10.4%
17/163 • Number of events 26 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
10.0%
50/499 • Number of events 113 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
12.7%
21/166 • Number of events 25 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
8/159 • Number of events 11 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
6.1%
10/163 • Number of events 11 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
8.4%
42/499 • Number of events 54 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
19.9%
33/166 • Number of events 42 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Constipation
|
6.9%
11/159 • Number of events 11 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
4.9%
8/163 • Number of events 10 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
5.0%
25/499 • Number of events 30 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
6.6%
11/166 • Number of events 11 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
8/159 • Number of events 11 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
3.7%
6/163 • Number of events 7 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
2.8%
14/499 • Number of events 17 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
3.0%
5/166 • Number of events 6 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
9/159 • Number of events 14 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
8.0%
13/163 • Number of events 13 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
4.2%
21/499 • Number of events 24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/166 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
General disorders
Fatigue
|
5.7%
9/159 • Number of events 10 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
7.4%
12/163 • Number of events 13 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
3.0%
15/499 • Number of events 16 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
3.6%
6/166 • Number of events 8 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.3%
10/159 • Number of events 10 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
2.5%
4/163 • Number of events 6 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
5.2%
26/499 • Number of events 30 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
2.4%
4/166 • Number of events 5 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
4.2%
1/24 • Number of events 1 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.3%
10/159 • Number of events 11 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
3.1%
5/163 • Number of events 5 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
3.4%
17/499 • Number of events 19 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
1.2%
2/166 • Number of events 2 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.7%
9/159 • Number of events 9 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
8.0%
13/163 • Number of events 13 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
10.0%
50/499 • Number of events 53 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
10.2%
17/166 • Number of events 17 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
0.00%
0/24 • The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
The Safety Analysis Set included all exposed subjects
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk reserves the right not to release data until specified milestones, e.g. a clinical trial report is available. This includes the right not to release interim results from clinical trials. At the end of the trial, one or more manuscripts for publication will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk will not suppress or veto publications. Novo Nordisk reserves the right to postpone publication for a short time to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER