Trial Outcomes & Findings for A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus. (NCT NCT02505334)
NCT ID: NCT02505334
Last Updated: 2018-09-05
Results Overview
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.
COMPLETED
PHASE3
635 participants
Week 0, Week 26
2018-09-05
Participant Flow
The trial was conducted at 47 sites in Japan: 47 sites screened and 45 of them randomised subjects. After screening, 635 subjects entered into the 12-week run-in period.
Subjects received liraglutide 0.9 mg/day (starting with 0.3 mg/day with subsequent weekly dose escalation of 0.3 mg to a maximum 0.9 mg/day) during 12 weeks run-in period. Subjects with HbA1c ≥7.0% at the end of run-in period were randomised (1:1) to two treatment arms: continuing liraglutide 0.9 mg/day or dose escalation to liraglutide 1.8 mg/day.
Participant milestones
| Measure |
Liraglutide 1.8 mg
Subjects received liraglutide once daily subcutaneous (s.c.; under the skin) injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Main Treatment Period
STARTED
|
233
|
233
|
|
Main Treatment Period
COMPLETED
|
218
|
194
|
|
Main Treatment Period
NOT COMPLETED
|
15
|
39
|
|
Extension Treatment Period
STARTED
|
212
|
0
|
|
Extension Treatment Period
COMPLETED
|
194
|
0
|
|
Extension Treatment Period
NOT COMPLETED
|
18
|
0
|
Reasons for withdrawal
| Measure |
Liraglutide 1.8 mg
Subjects received liraglutide once daily subcutaneous (s.c.; under the skin) injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Main Treatment Period
Adverse Event
|
3
|
3
|
|
Main Treatment Period
Lack of Efficacy
|
7
|
17
|
|
Main Treatment Period
Protocol Violation
|
0
|
1
|
|
Main Treatment Period
Withdrawal by Subject
|
1
|
8
|
|
Main Treatment Period
Unclassified
|
4
|
10
|
|
Extension Treatment Period
Adverse Event
|
5
|
0
|
|
Extension Treatment Period
Lack of Efficacy
|
4
|
0
|
|
Extension Treatment Period
Withdrawal by Subject
|
6
|
0
|
|
Extension Treatment Period
Unclassified
|
3
|
0
|
Baseline Characteristics
A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.
Baseline characteristics by cohort
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.07 Years
STANDARD_DEVIATION 10.27 • n=99 Participants
|
54.96 Years
STANDARD_DEVIATION 10.61 • n=107 Participants
|
55.01 Years
STANDARD_DEVIATION 10.43 • n=206 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=99 Participants
|
165 Participants
n=107 Participants
|
321 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
233 Participants
n=99 Participants
|
233 Participants
n=107 Participants
|
466 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.14 Percentage (%) of HbA1c
STANDARD_DEVIATION 1.02 • n=99 Participants
|
8.10 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.87 • n=107 Participants
|
8.12 Percentage (%) of HbA1c
STANDARD_DEVIATION 0.95 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 26Population: FAS, which included all randomised subjects. Missing values were imputed using the last observation carried forward (LOCF) method.
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
|
-0.23 Percentage (%) of HbA1c
Standard Error 0.06
|
0.17 Percentage (%) of HbA1c
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 0, Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for this outcome measure, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in HbA1c (Week 52)
Week 0: Baseline
|
8.14 Percentage (%) of HbA1c
Standard Deviation 1.02
|
—
|
|
Change in HbA1c (Week 52)
Week 52: Change from baseline
|
-0.09 Percentage (%) of HbA1c
Standard Deviation 1.05
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c values were imputed using the LOCF method.
Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Responder for HbA1c Below 7.0% (53 mmol/Mol)
Week 26
|
53 Participants
|
18 Participants
|
|
Responder for HbA1c Below 7.0% (53 mmol/Mol)
Week 52
|
45 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c values were imputed using the LOCF method.
Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Week 26
|
18 Participants
|
5 Participants
|
|
Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Week 52
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c and body weight values were imputed using the LOCF method.
Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Responder for HbA1c Below 7.0% Without Weight Gain
Week 26
|
36 Participants
|
13 Participants
|
|
Responder for HbA1c Below 7.0% Without Weight Gain
Week 52
|
35 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c values were imputed using the LOCF method.
Reported results are subjects with HbA1c \<7.0% after 26 weeks and 52 weeks of treatment, respectively without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. Severe or BG confirmed symptomatic hypoglycaemia: severe as per ADA classification or BG confirmed by plasma glucose (PG) value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk)0) and no later than 7 days after the last day on liraglutide (maximum till wk26+7days and wk52+7days). Hence, the following shown 'Time Frame' should be read as 'Wk26+7days and Wk52+7days'
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Week 26
|
53 Participants
|
18 Participants
|
|
Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Week 52
|
45 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 26 and Week 52Population: FAS, which included all randomised subjects. Number analyzed = number of subjects contributed to the analysis. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method
Reported results are 7-point SMBG values at week 0, week 26 and week 52. The 7-point profile blood glucose levels were measured at the following time points always starting with the first: 1. Before breakfast. 2. 90 minutes after start of breakfast. 3. Before lunch. 4. 90 minutes after start of lunch. 5. Before dinner. 6. 90 minutes after start of dinner. 7. At bedtime.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 52: Before dinner
|
164.3 mg/dL
Standard Deviation 50.8
|
—
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 0: Before breakfast
|
181.8 mg/dL
Standard Deviation 42.8
|
177.1 mg/dL
Standard Deviation 43.4
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 0: 90 minutes after start of dinner
|
254.3 mg/dL
Standard Deviation 66.2
|
249.5 mg/dL
Standard Deviation 63.2
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 0: 90 minutes after start of breakfast
|
262.6 mg/dL
Standard Deviation 65.0
|
266.5 mg/dL
Standard Deviation 70.0
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 0: Before lunch
|
169.5 mg/dL
Standard Deviation 57.7
|
177.6 mg/dL
Standard Deviation 61.7
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 0: 90 minutes after start of lunch
|
253.1 mg/dL
Standard Deviation 64.5
|
252.2 mg/dL
Standard Deviation 63.5
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 0: Before dinner
|
173.4 mg/dL
Standard Deviation 59.2
|
169.7 mg/dL
Standard Deviation 56.5
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 0: At bedtime
|
226.1 mg/dL
Standard Deviation 67.4
|
217.8 mg/dL
Standard Deviation 58.7
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 26: Before breakfast
|
171.7 mg/dL
Standard Deviation 39.6
|
178.2 mg/dL
Standard Deviation 44.4
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 26: 90 minutes after start of breakfast
|
247.2 mg/dL
Standard Deviation 64.6
|
258.2 mg/dL
Standard Deviation 63.7
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 26: Before lunch
|
161.2 mg/dL
Standard Deviation 51.0
|
177.0 mg/dL
Standard Deviation 57.9
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 26: 90 minutes after start of lunch
|
234.7 mg/dL
Standard Deviation 63.3
|
255.3 mg/dL
Standard Deviation 66.7
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 26: Before dinner
|
162.3 mg/dL
Standard Deviation 47.5
|
168.6 mg/dL
Standard Deviation 57.5
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 26: 90 minutes after start of dinner
|
233.3 mg/dL
Standard Deviation 60.1
|
251.5 mg/dL
Standard Deviation 64.9
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 26: At bedtime
|
205.6 mg/dL
Standard Deviation 58.6
|
220.5 mg/dL
Standard Deviation 68.8
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 52: Before breakfast
|
176.1 mg/dL
Standard Deviation 43.2
|
—
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 52: 90 minutes after start of breakfast
|
251.1 mg/dL
Standard Deviation 69.1
|
—
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 52: Before lunch
|
169.6 mg/dL
Standard Deviation 59.7
|
—
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 52: 90 minutes after start of lunch
|
243.3 mg/dL
Standard Deviation 63.9
|
—
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 52: 90 minutes after start of dinner
|
240.5 mg/dL
Standard Deviation 65.8
|
—
|
|
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Week 52: At bedtime
|
207.9 mg/dL
Standard Deviation 66.7
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: FAS, which included all randomised subjects. Number analyzed = number of subjects contributed to the analysis. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in SMBG 7-point Profile: Mean of 7-point Profile
Baseline (week 0)
|
217.9 mg/dL
Standard Deviation 46.7
|
217.7 mg/dL
Standard Deviation 46.8
|
|
Change in SMBG 7-point Profile: Mean of 7-point Profile
Change from baseline: week 26
|
-14.5 mg/dL
Standard Deviation 39.0
|
-0.6 mg/dL
Standard Deviation 45.0
|
|
Change in SMBG 7-point Profile: Mean of 7-point Profile
Change from baseline: week 52
|
-8.9 mg/dL
Standard Deviation 43.7
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: FAS, which included all randomised subjects. Number analyzed = number of subjects contributed to the analysis. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
Week 52: Change from baseline
|
-6.3 mg/dL
Standard Deviation 44.4
|
—
|
|
Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
Week 0: Baseline
|
81.7 mg/dL
Standard Deviation 38.7
|
81.6 mg/dL
Standard Deviation 38.6
|
|
Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
Week 26: Change from baseline
|
-8.4 mg/dL
Standard Deviation 43.8
|
-1.5 mg/dL
Standard Deviation 39.5
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
Week 0: Baseline
|
172.5 mg/dL
Standard Deviation 38.7
|
172.0 mg/dL
Standard Deviation 38.3
|
|
Change in Fasting Plasma Glucose (FPG)
Week 26: Change from baseline
|
-8.4 mg/dL
Standard Deviation 36.7
|
1.0 mg/dL
Standard Deviation 33.7
|
|
Change in Fasting Plasma Glucose (FPG)
Week 52: Change from baseline
|
-1.2 mg/dL
Standard Deviation 39.0
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Waist Circumference
Week 0: Baseline
|
93.68 Centimeter (cm)
Standard Deviation 11.75
|
93.82 Centimeter (cm)
Standard Deviation 11.50
|
|
Change in Waist Circumference
Week 26: Change from baseline
|
-0.44 Centimeter (cm)
Standard Deviation 3.04
|
-0.73 Centimeter (cm)
Standard Deviation 3.03
|
|
Change in Waist Circumference
Week 52: Change from baseline
|
-1.07 Centimeter (cm)
Standard Deviation 3.64
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Body Weight
Week 0: Baseline
|
74.67 Kilogram (kg)
Standard Deviation 15.24
|
75.13 Kilogram (kg)
Standard Deviation 16.46
|
|
Change in Body Weight
Week 26: Change from baseline
|
-0.77 Kilogram (kg)
Standard Deviation 2.01
|
-0.95 Kilogram (kg)
Standard Deviation 2.19
|
|
Change in Body Weight
Week 52: Change from baseline
|
-1.05 Kilogram (kg)
Standard Deviation 2.26
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
Week 0: Baseline
|
27.34 kg/m^2
Standard Deviation 4.80
|
27.20 kg/m^2
Standard Deviation 4.72
|
|
Change in Body Mass Index (BMI)
Week 26: Change from baseline
|
-0.28 kg/m^2
Standard Deviation 0.72
|
-0.33 kg/m^2
Standard Deviation 0.78
|
|
Change in Body Mass Index (BMI)
Week 52: Change from baseline
|
-0.39 kg/m^2
Standard Deviation 0.82
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 0: SBP, Baseline
|
128.0 mmHg
Standard Deviation 13.1
|
128.8 mmHg
Standard Deviation 13.1
|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 26: SBP, change from baseline
|
-1.7 mmHg
Standard Deviation 12.8
|
0.4 mmHg
Standard Deviation 12.2
|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 52: SBP, change from baseline
|
-0.9 mmHg
Standard Deviation 12.5
|
—
|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 0: DBP, Baseline
|
79.6 mmHg
Standard Deviation 9.1
|
80.3 mmHg
Standard Deviation 9.8
|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 26: DBP, change from baseline
|
-0.9 mmHg
Standard Deviation 8.7
|
0.1 mmHg
Standard Deviation 7.8
|
|
Change in Blood Pressure (Systolic and Diastolic)
Week 52: DBP, change from baseline
|
-0.6 mmHg
Standard Deviation 8.4
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Fasting C-peptide
Week 26
|
1.946 ng/mL
Geometric Coefficient of Variation 41.9
|
1.853 ng/mL
Geometric Coefficient of Variation 40.8
|
|
Fasting C-peptide
Week 52
|
1.906 ng/mL
Geometric Coefficient of Variation 42.2
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Fasting Insulin
Week 26
|
77.00 pmol/L
Geometric Coefficient of Variation 70.9
|
70.91 pmol/L
Geometric Coefficient of Variation 65.3
|
|
Fasting Insulin
Week 52
|
77.31 pmol/L
Geometric Coefficient of Variation 68.7
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Fasting Glucagon
Week 26
|
22.5 pmol/L
Geometric Coefficient of Variation 30.0
|
23.4 pmol/L
Geometric Coefficient of Variation 26.8
|
|
Fasting Glucagon
Week 52
|
23.4 pmol/L
Geometric Coefficient of Variation 30.2
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Proinsulin
Week 26
|
15.638 pmol/L
Geometric Coefficient of Variation 111.2
|
16.054 pmol/L
Geometric Coefficient of Variation 101.8
|
|
Proinsulin
Week 52
|
16.217 pmol/L
Geometric Coefficient of Variation 107.4
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Proinsulin/Insulin
Week 26
|
20.31 Percentage (%) of proinsulin/insulin
Geometric Coefficient of Variation 70.7
|
22.64 Percentage (%) of proinsulin/insulin
Geometric Coefficient of Variation 70.6
|
|
Proinsulin/Insulin
Week 52
|
20.98 Percentage (%) of proinsulin/insulin
Geometric Coefficient of Variation 72.5
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
HOMA-B was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=\[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)\].
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Week 26
|
42.06 Percentage (%) of beta-cell function
Geometric Coefficient of Variation 73.0
|
35.54 Percentage (%) of beta-cell function
Geometric Coefficient of Variation 72.9
|
|
Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Week 52
|
40.03 Percentage (%) of beta-cell function
Geometric Coefficient of Variation 79.5
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
HOMA-IR was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Week 26
|
4.388 HOMA-IR score
Geometric Coefficient of Variation 81.9
|
4.262 HOMA-IR score
Geometric Coefficient of Variation 73.5
|
|
Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Week 52
|
4.567 HOMA-IR score
Geometric Coefficient of Variation 77.5
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Total Cholesterol
Week 26
|
191.2 mg/dL
Geometric Coefficient of Variation 17.6
|
194.5 mg/dL
Geometric Coefficient of Variation 16.1
|
|
Total Cholesterol
Week 52
|
190.6 mg/dL
Geometric Coefficient of Variation 16.3
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Low Density Lipoprotein (LDL) Cholesterol
Week 26
|
103.4 mg/dL
Geometric Coefficient of Variation 31.6
|
107.1 mg/dL
Geometric Coefficient of Variation 27.8
|
|
Low Density Lipoprotein (LDL) Cholesterol
Week 52
|
104.5 mg/dL
Geometric Coefficient of Variation 26.2
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
High Density Lipoprotein (HDL) Cholesterol
Week 26
|
52.7 mg/dL
Geometric Coefficient of Variation 25.6
|
52.9 mg/dL
Geometric Coefficient of Variation 26.3
|
|
High Density Lipoprotein (HDL) Cholesterol
Week 52
|
53.3 mg/dL
Geometric Coefficient of Variation 24.7
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Very Low Density Lipoprotein (VLDL) Cholesterol
Week 26
|
26.8 mg/dL
Geometric Coefficient of Variation 56.7
|
27.8 mg/dL
Geometric Coefficient of Variation 49.4
|
|
Very Low Density Lipoprotein (VLDL) Cholesterol
Week 52
|
25.9 mg/dL
Geometric Coefficient of Variation 55.2
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Triglycerides
Week 26
|
135.4 mg/dL
Geometric Coefficient of Variation 60.1
|
142.3 mg/dL
Geometric Coefficient of Variation 54.9
|
|
Triglycerides
Week 52
|
130.4 mg/dL
Geometric Coefficient of Variation 57.0
|
—
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: FAS, which included all randomised subjects. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Free Fatty Acids
Week 26
|
12.56 mg/dL
Geometric Coefficient of Variation 47.4
|
12.99 mg/dL
Geometric Coefficient of Variation 43.9
|
|
Free Fatty Acids
Week 52
|
12.19 mg/dL
Geometric Coefficient of Variation 44.3
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-26 and Weeks 0-52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for weeks 0-52, as the subjects in this treatment arm received treatment for 26 weeks (main period).
Treatment emergent adverse events (TEAEs) were evaluated during the 26-week and 52-week treatment period, respectively. TEAE for weeks 0-26: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days). TEAE for weeks 0-52: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 52 + 7 days). Hence, the following shown 'Time Frame' should be read as 'Weeks 0-26 + 7 days and Weeks 0-52 + 7 days'.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events
Weeks 0-26
|
365 Events
|
266 Events
|
|
Number of Treatment Emergent Adverse Events
Weeks 0-52
|
588 Events
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-26 and Weeks 0-52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for weeks 0-52, as the subjects in this treatment arm received treatment for 26 weeks (main period).
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the 26-week and 52-week treatment period, respectively. Severe or BG confirmed symptomatic hypoglycaemia (hypo):An episode that was severe according to the ADA classification or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypo. ADA definition of severe hypo:episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk) 0) and no later than 7 days after the last day on liraglutide (maximum till wk 26 and wk 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'wk 0-26+7 days and wk 0-52+7 days'.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Weeks 0-26
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Weeks 0-52
|
0 Episodes
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-26 and Weeks 0-52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period).
Treatment emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the26-week and 52-week treatment period, respectively. Nocturnal hypoglycaemic episodes: Those occurring between 00:01 and 05:59 hours, both inclusive. Severe or BG confirmed symptomatic hypoglycaemia: episode that was severe according to the ADA classification or BG confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Treatment emergent: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Weeks 0-26
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Weeks 0-52
|
0 Episodes
|
—
|
SECONDARY outcome
Timeframe: Weeks 0-26 and Weeks 0-52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period).
American Diabetes Association (ADA) classification of hypoglycaemia: 1. Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2. Documented symptomatic: PG level ≤3.9 mmol/L with symptoms. 3. Asymptomatic: PG level ≤3.9 mmol/L without symptoms. 4. Probable symptomatic: No measurement with symptoms. 5. Pseudo: PG level \>3.9 mmol/L with symptoms. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-26: Asymptomatic hypoglycaemia
|
2 Episodes
|
1 Episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-26: Probable symptomatic hypoglycaemia
|
3 Episodes
|
1 Episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-26: Severe hypoglycaemia
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-26: Documented symptomatic hypoglycaemia
|
0 Episodes
|
0 Episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-26: Pseudo-hypoglycaemia
|
2 Episodes
|
1 Episodes
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-52: Severe hypoglycaemia
|
0 Episodes
|
—
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-52: Documented symptomatic hypoglycaemia
|
0 Episodes
|
—
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-52: Asymptomatic hypoglycaemia
|
3 Episodes
|
—
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-52: Probable symptomatic hypoglycaemia
|
4 Episodes
|
—
|
|
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Weeks 0-52: Pseudo-hypoglycaemia
|
2 Episodes
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Pulse
Week 0: Baseline
|
80.2 Beats/minute
Standard Deviation 9.8
|
80.8 Beats/minute
Standard Deviation 10.4
|
|
Change in Pulse
Week 26: Change from baseline
|
0.8 Beats/minute
Standard Deviation 7.8
|
0.2 Beats/minute
Standard Deviation 7.9
|
|
Change in Pulse
Week 52: Change from baseline
|
0.2 Beats/minute
Standard Deviation 8.1
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Reported results are physical examination outcomes at week (wk) 0, wk 26 and wk 52. Physical examination consisted of the following listed examinations and the outcome of each examination was evaluated as: 1) normal, 2) abnormal, not clinically significant (NCS) or 3) abnormal, clinically significant (CS). 1. Cardiovascular system 2. Central and peripheral nervous system (PNS) 3. Gastrointestinal (GI) system including mouth 4. General appearance 5. Head, ears, eyes, nose, throat, neck 6. Lymph node palpation 7. Musculoskeletal system 8. Respiratory system 9. Skin 10. Thyroid gland
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Physical Examination
Cardiovascular system: Wk 26: Abnormal, NCS
|
2 Participants
|
0 Participants
|
|
Change in Physical Examination
Central and PNS: Wk 0: Abnormal, CS
|
1 Participants
|
3 Participants
|
|
Change in Physical Examination
Central and PNS: Wk 52: Abnormal, CS
|
1 Participants
|
—
|
|
Change in Physical Examination
General appearance: Wk 26: Normal
|
229 Participants
|
233 Participants
|
|
Change in Physical Examination
Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,CS
|
4 Participants
|
4 Participants
|
|
Change in Physical Examination
Musculoskeletal system: Wk 0: Abnormal, NCS
|
4 Participants
|
0 Participants
|
|
Change in Physical Examination
Musculoskeletal system: Wk 0: Abnormal, CS
|
3 Participants
|
2 Participants
|
|
Change in Physical Examination
Musculoskeletal system: Wk 26: Normal
|
224 Participants
|
230 Participants
|
|
Change in Physical Examination
Respiratory system: Wk 26: Normal
|
232 Participants
|
232 Participants
|
|
Change in Physical Examination
Skin: Wk 0: Abnormal, CS
|
4 Participants
|
7 Participants
|
|
Change in Physical Examination
Cardiovascular system: Wk 0: Normal
|
229 Participants
|
230 Participants
|
|
Change in Physical Examination
Cardiovascular system: Wk 0: Abnormal, NCS
|
3 Participants
|
0 Participants
|
|
Change in Physical Examination
Cardiovascular system: Wk 0: Abnormal, CS
|
1 Participants
|
3 Participants
|
|
Change in Physical Examination
Cardiovascular system: Wk 26: Normal
|
230 Participants
|
229 Participants
|
|
Change in Physical Examination
Cardiovascular system: Week 26: Abnormal, CS
|
1 Participants
|
4 Participants
|
|
Change in Physical Examination
Cardiovascular system: Wk 52: Normal
|
227 Participants
|
—
|
|
Change in Physical Examination
Cardiovascular system: Wk 52: Abnormal, NCS
|
4 Participants
|
—
|
|
Change in Physical Examination
Cardiovascular system: Wk 52: Abnormal, CS
|
2 Participants
|
—
|
|
Change in Physical Examination
Central and PNS: Wk 0: Normal
|
232 Participants
|
229 Participants
|
|
Change in Physical Examination
Central and PNS: Wk 0: Abnormal, NCS
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Central and PNS: Wk 26: Normal
|
231 Participants
|
229 Participants
|
|
Change in Physical Examination
Central and PNS: Wk 26: Abnormal, NCS
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Central and PNS: Wk 26: Abnormal, CS
|
2 Participants
|
3 Participants
|
|
Change in Physical Examination
Central and PNS: Wk 52: Normal
|
232 Participants
|
—
|
|
Change in Physical Examination
Central and PNS: Wk 52: Abnormal, NCS
|
0 Participants
|
—
|
|
Change in Physical Examination
GI system including mouth: Wk 0: Normal
|
227 Participants
|
226 Participants
|
|
Change in Physical Examination
GI system including mouth: Wk 0: Abnormal, NCS
|
0 Participants
|
4 Participants
|
|
Change in Physical Examination
GI system including mouth: Wk 0: Abnormal, CS
|
6 Participants
|
3 Participants
|
|
Change in Physical Examination
GI system including mouth: Wk 26: Normal
|
227 Participants
|
226 Participants
|
|
Change in Physical Examination
GI system including mouth: Wk 26: Abnormal, NCS
|
0 Participants
|
3 Participants
|
|
Change in Physical Examination
GI system including mouth: Wk 26: Abnormal, CS
|
6 Participants
|
4 Participants
|
|
Change in Physical Examination
GI system including mouth: Wk 52: Normal
|
226 Participants
|
—
|
|
Change in Physical Examination
GI system including mouth: Wk 52: Abnormal, NCS
|
2 Participants
|
—
|
|
Change in Physical Examination
GI system including mouth: Wk 52: Abnormal, CS
|
5 Participants
|
—
|
|
Change in Physical Examination
General appearance: Wk 0: Normal
|
229 Participants
|
232 Participants
|
|
Change in Physical Examination
General appearance: Wk 0: Abnormal, NCS
|
4 Participants
|
1 Participants
|
|
Change in Physical Examination
General appearance: Wk 0: Abnormal, CS
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
General appearance: Wk 26: Abnormal, NCS
|
4 Participants
|
0 Participants
|
|
Change in Physical Examination
General appearance: Wk 26: Abnormal, CS
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
General appearance: Wk 52: Normal
|
229 Participants
|
—
|
|
Change in Physical Examination
General appearance: Wk 52: Abnormal, NCS
|
4 Participants
|
—
|
|
Change in Physical Examination
General appearance: Wk 52: Abnormal, CS
|
0 Participants
|
—
|
|
Change in Physical Examination
Head,ears,eyes,nose,throat,neck: Wk0:Normal
|
225 Participants
|
226 Participants
|
|
Change in Physical Examination
Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,NCS
|
3 Participants
|
2 Participants
|
|
Change in Physical Examination
Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,CS
|
5 Participants
|
5 Participants
|
|
Change in Physical Examination
Head,ears,eyes,nose,throat,neck: Wk26:Normal
|
225 Participants
|
228 Participants
|
|
Change in Physical Examination
Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,NCS
|
4 Participants
|
1 Participants
|
|
Change in Physical Examination
Head,ears,eyes,nose,throat,neck: Wk52:Normal
|
223 Participants
|
—
|
|
Change in Physical Examination
Head,ears,eyes,nose,throat,neck: Wk52:Abnormal,NCS
|
5 Participants
|
—
|
|
Change in Physical Examination
Head,ears,eyes,nose,throat,neck: Wk52:Abnormal,CS
|
5 Participants
|
—
|
|
Change in Physical Examination
Lymph node palpation: Wk 0: Normal
|
233 Participants
|
233 Participants
|
|
Change in Physical Examination
Lymph node palpation: Wk 0: Abnormal, NCS
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Lymph node palpation: Wk 0: Abnormal, CS
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Lymph node palpation: Wk 26: Normal
|
233 Participants
|
233 Participants
|
|
Change in Physical Examination
Lymph node palpation: Wk 26: Abnormal, NCS
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Lymph node palpation: Wk 26: Abnormal, CS
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Lymph node palpation: Wk 52: Normal
|
233 Participants
|
—
|
|
Change in Physical Examination
Lymph node palpation: Wk 52: Abnormal, NCS
|
0 Participants
|
—
|
|
Change in Physical Examination
Lymph node palpation: Wk 52: Abnormal, CS
|
0 Participants
|
—
|
|
Change in Physical Examination
Musculoskeletal system: Wk 0: Normal
|
226 Participants
|
231 Participants
|
|
Change in Physical Examination
Musculoskeletal system: Wk 26: Abnormal, NCS
|
5 Participants
|
0 Participants
|
|
Change in Physical Examination
Musculoskeletal system: Wk 26: Abnormal, CS
|
4 Participants
|
3 Participants
|
|
Change in Physical Examination
Musculoskeletal system: Wk 52: Normal
|
224 Participants
|
—
|
|
Change in Physical Examination
Musculoskeletal system: Wk 52: Abnormal, NCS
|
5 Participants
|
—
|
|
Change in Physical Examination
Musculoskeletal system: Wk 52: Abnormal, CS
|
4 Participants
|
—
|
|
Change in Physical Examination
Respiratory system: Wk 0: Normal
|
233 Participants
|
232 Participants
|
|
Change in Physical Examination
Respiratory system: Wk 0: Abnormal, NCS
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Respiratory system: Wk 0: Abnormal, CS
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Respiratory system: Wk 26: Abnormal, NCS
|
0 Participants
|
1 Participants
|
|
Change in Physical Examination
Respiratory system: Wk 26: Abnormal, CS
|
1 Participants
|
0 Participants
|
|
Change in Physical Examination
Respiratory system: Wk 52: Normal
|
232 Participants
|
—
|
|
Change in Physical Examination
Respiratory system: Wk 52: Abnormal, NCS
|
0 Participants
|
—
|
|
Change in Physical Examination
Respiratory system: Wk 52: Abnormal, CS
|
1 Participants
|
—
|
|
Change in Physical Examination
Skin: Wk 0: Normal
|
225 Participants
|
223 Participants
|
|
Change in Physical Examination
Skin: Wk 0: Abnormal, NCS
|
4 Participants
|
3 Participants
|
|
Change in Physical Examination
Skin: Wk 26: Normal
|
218 Participants
|
222 Participants
|
|
Change in Physical Examination
Skin: Wk 26: Abnormal, NCS
|
4 Participants
|
4 Participants
|
|
Change in Physical Examination
Skin: Wk 26: Abnormal, CS
|
11 Participants
|
7 Participants
|
|
Change in Physical Examination
Skin: Wk 52: Normal
|
224 Participants
|
—
|
|
Change in Physical Examination
Skin: Wk 52: Abnormal, NCS
|
4 Participants
|
—
|
|
Change in Physical Examination
Skin: Wk 52: Abnormal, CS
|
5 Participants
|
—
|
|
Change in Physical Examination
Thyroid gland: Wk 0: Normal
|
232 Participants
|
232 Participants
|
|
Change in Physical Examination
Thyroid gland: Wk 0: Abnormal, NCS
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Thyroid gland: Wk 0: Abnormal, CS
|
1 Participants
|
1 Participants
|
|
Change in Physical Examination
Thyroid gland: Wk 26: Normal
|
232 Participants
|
232 Participants
|
|
Change in Physical Examination
Thyroid gland: Wk 26: Abnormal, NCS
|
0 Participants
|
0 Participants
|
|
Change in Physical Examination
Thyroid gland: Wk 26: Abnormal, CS
|
1 Participants
|
1 Participants
|
|
Change in Physical Examination
Thyroid gland: Wk 52: Normal
|
232 Participants
|
—
|
|
Change in Physical Examination
Thyroid gland: Wk 52: Abnormal, NCS
|
0 Participants
|
—
|
|
Change in Physical Examination
Thyroid gland: Wk 52: Abnormal, CS
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Reported results are eye examination (ophthalmoscopy) outcomes at week 0, week 26 and week 52. Ophthalmoscopy outcomes for both left and right eye were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Eye Examination
Week 0: Left eye - Normal
|
183 Participants
|
176 Participants
|
|
Change in Eye Examination
Week 0: Left eye - Abnormal, NCS
|
15 Participants
|
13 Participants
|
|
Change in Eye Examination
Week 0: Left eye - Abnormal, CS
|
35 Participants
|
44 Participants
|
|
Change in Eye Examination
Week 26: Left eye - Normal
|
178 Participants
|
178 Participants
|
|
Change in Eye Examination
Week 26: Left eye - Abnormal, NCS
|
18 Participants
|
15 Participants
|
|
Change in Eye Examination
Week 26: Left eye - Abnormal, CS
|
37 Participants
|
40 Participants
|
|
Change in Eye Examination
Week 52: Left eye - Normal
|
181 Participants
|
—
|
|
Change in Eye Examination
Week 52: Left eye - Abnormal, NCS
|
16 Participants
|
—
|
|
Change in Eye Examination
Week 52: Left eye - Abnormal, CS
|
36 Participants
|
—
|
|
Change in Eye Examination
Week 0: Right eye - Normal
|
183 Participants
|
180 Participants
|
|
Change in Eye Examination
Week 0: Right eye - Abnormal, NCS
|
14 Participants
|
11 Participants
|
|
Change in Eye Examination
Week 0: Right eye - Abnormal, CS
|
36 Participants
|
42 Participants
|
|
Change in Eye Examination
Week 26: Right eye - Normal
|
176 Participants
|
180 Participants
|
|
Change in Eye Examination
Week 26: Right eye - Abnormal, NCS
|
19 Participants
|
14 Participants
|
|
Change in Eye Examination
Week 26: Right eye - Abnormal, CS
|
38 Participants
|
39 Participants
|
|
Change in Eye Examination
Week 52: Right eye - Normal
|
177 Participants
|
—
|
|
Change in Eye Examination
Week 52: Right eye - Abnormal, NCS
|
18 Participants
|
—
|
|
Change in Eye Examination
Week 52: Right eye - Abnormal, CS
|
38 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Reported results are ECG outcomes at week 0, week 26 and week 52. ECG outcomes were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Electrocardiogram (ECG)
Week 26: Abnormal, CS
|
2 Participants
|
3 Participants
|
|
Change in Electrocardiogram (ECG)
Week 0: Normal
|
202 Participants
|
196 Participants
|
|
Change in Electrocardiogram (ECG)
Week 0: Abnormal, NCS
|
31 Participants
|
35 Participants
|
|
Change in Electrocardiogram (ECG)
Week 0: Abnormal, CS
|
0 Participants
|
2 Participants
|
|
Change in Electrocardiogram (ECG)
Week 26: Normal
|
205 Participants
|
204 Participants
|
|
Change in Electrocardiogram (ECG)
Week 26: Abnormal, NCS
|
26 Participants
|
26 Participants
|
|
Change in Electrocardiogram (ECG)
Week 52: Normal
|
203 Participants
|
—
|
|
Change in Electrocardiogram (ECG)
Week 52: Abnormal, NCS
|
28 Participants
|
—
|
|
Change in Electrocardiogram (ECG)
Week 52: Abnormal, CS
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Creatinine
Week 0: Baseline
|
0.802 mg/dL
Standard Deviation 0.144
|
0.822 mg/dL
Standard Deviation 0.164
|
|
Change in Biochemistry: Creatinine
Week 26: Change from baseline
|
0.018 mg/dL
Standard Deviation 0.070
|
0.011 mg/dL
Standard Deviation 0.080
|
|
Change in Biochemistry: Creatinine
Week 52: Change from baseline
|
0.025 mg/dL
Standard Deviation 0.078
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in estimated glomerular filtration rate (eGFR) was evaluated after 26 weeks and 52 weeks of treatment, respectively. eGFR was evaluated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, mL/min/1.73m\^2.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: eGFR
Week 0: Baseline
|
78.6 mL/min/1.73m^2
Standard Deviation 9.5
|
77.6 mL/min/1.73m^2
Standard Deviation 10.7
|
|
Change in Biochemistry: eGFR
Week 26: Change from baseline
|
-1.5 mL/min/1.73m^2
Standard Deviation 5.0
|
-1.0 mL/min/1.73m^2
Standard Deviation 5.8
|
|
Change in Biochemistry: eGFR
Week 52: Change from baseline
|
-2.3 mL/min/1.73m^2
Standard Deviation 5.6
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Alanine Aminotransferase
Week 0: Baseline
|
32.7 U/L
Standard Deviation 19.5
|
34.2 U/L
Standard Deviation 21.8
|
|
Change in Biochemistry: Alanine Aminotransferase
Week 26: Change from baseline
|
-0.4 U/L
Standard Deviation 12.0
|
-2.2 U/L
Standard Deviation 13.9
|
|
Change in Biochemistry: Alanine Aminotransferase
Week 52: Change from baseline
|
-2.4 U/L
Standard Deviation 11.9
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Aspartate Aminotransferase
Week 0: Baseline
|
26.5 U/L
Standard Deviation 12.8
|
26.9 U/L
Standard Deviation 13.9
|
|
Change in Biochemistry: Aspartate Aminotransferase
Week 26: Change from baseline
|
0.2 U/L
Standard Deviation 9.9
|
-1.0 U/L
Standard Deviation 8.6
|
|
Change in Biochemistry: Aspartate Aminotransferase
Week 52: Change from baseline
|
-1.2 U/L
Standard Deviation 8.9
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Alkaline Phosphatase
Week 0: Baseline
|
72.5 U/L
Standard Deviation 20.6
|
74.1 U/L
Standard Deviation 22.1
|
|
Change in Biochemistry: Alkaline Phosphatase
Week 26: Change from baseline
|
0.6 U/L
Standard Deviation 9.8
|
2.0 U/L
Standard Deviation 12.4
|
|
Change in Biochemistry: Alkaline Phosphatase
Week 52: Change from baseline
|
2.1 U/L
Standard Deviation 11.1
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Sodium
Week 0: Baseline
|
140.2 mmol/L
Standard Deviation 1.9
|
140.2 mmol/L
Standard Deviation 1.9
|
|
Change in Biochemistry: Sodium
Week 26: Change from baseline
|
0.1 mmol/L
Standard Deviation 1.8
|
0.2 mmol/L
Standard Deviation 2.0
|
|
Change in Biochemistry: Sodium
Week 52: Change from baseline
|
0.3 mmol/L
Standard Deviation 1.8
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Potassium
Week 0: Baseline
|
4.40 mmol/L
Standard Deviation 0.34
|
4.38 mmol/L
Standard Deviation 0.34
|
|
Change in Biochemistry: Potassium
Week 26: Change from baseline
|
-0.01 mmol/L
Standard Deviation 0.32
|
-0.02 mmol/L
Standard Deviation 0.29
|
|
Change in Biochemistry: Potassium
Week 52: Change from baseline
|
0.00 mmol/L
Standard Deviation 0.31
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Albumin
Week 0: Baseline
|
44.7 g/L
Standard Deviation 2.5
|
45.1 g/L
Standard Deviation 2.2
|
|
Change in Biochemistry: Albumin
Week 26: Change from baseline
|
-0.2 g/L
Standard Deviation 2.1
|
-0.2 g/L
Standard Deviation 1.9
|
|
Change in Biochemistry: Albumin
Week 52: Change from baseline
|
-0.2 g/L
Standard Deviation 2.2
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Total Bilirubin
Week 0: Baseline
|
0.52 mg/dL
Standard Deviation 0.29
|
0.53 mg/dL
Standard Deviation 0.25
|
|
Change in Biochemistry: Total Bilirubin
Week 26: Change from baseline
|
0.04 mg/dL
Standard Deviation 0.25
|
0.04 mg/dL
Standard Deviation 0.24
|
|
Change in Biochemistry: Total Bilirubin
Week 52: Change from baseline
|
0.06 mg/dL
Standard Deviation 0.23
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Urea
Week 0: Baseline
|
13.5 mg/dL
Standard Deviation 3.2
|
14.0 mg/dL
Standard Deviation 3.7
|
|
Change in Biochemistry: Urea
Week 26: Change from baseline
|
0.3 mg/dL
Standard Deviation 3.0
|
-0.0 mg/dL
Standard Deviation 3.3
|
|
Change in Biochemistry: Urea
Week 52: Change from baseline
|
0.7 mg/dL
Standard Deviation 2.8
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Creatine Kinase
Week 0: Baseline
|
117.3 U/L
Standard Deviation 61.8
|
129.3 U/L
Standard Deviation 100.3
|
|
Change in Biochemistry: Creatine Kinase
Week 26: Change from baseline
|
5.2 U/L
Standard Deviation 50.9
|
-5.2 U/L
Standard Deviation 96.3
|
|
Change in Biochemistry: Creatine Kinase
Week 52: Change from baseline
|
7.5 U/L
Standard Deviation 54.8
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Calcium
Week 0: Baseline
|
9.66 mg/dL
Standard Deviation 0.41
|
9.66 mg/dL
Standard Deviation 0.37
|
|
Change in Biochemistry: Calcium
Week 26: Change from baseline
|
-0.01 mg/dL
Standard Deviation 0.41
|
0.01 mg/dL
Standard Deviation 0.39
|
|
Change in Biochemistry: Calcium
Week 52: Change from baseline
|
0.01 mg/dL
Standard Deviation 0.41
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Albumin Corrected Calcium
Week 26: Change from baseline
|
0.00 mg/dL
Standard Deviation 0.37
|
0.02 mg/dL
Standard Deviation 0.35
|
|
Change in Biochemistry: Albumin Corrected Calcium
Week 0: Baseline
|
9.28 mg/dL
Standard Deviation 0.35
|
9.26 mg/dL
Standard Deviation 0.32
|
|
Change in Biochemistry: Albumin Corrected Calcium
Week 52: Change from baseline
|
0.02 mg/dL
Standard Deviation 0.36
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Amylase
Week 0: Baseline
|
62.3 U/L
Standard Deviation 23.1
|
61.1 U/L
Standard Deviation 22.5
|
|
Change in Biochemistry: Amylase
Week 26: Change from baseline
|
-0.9 U/L
Standard Deviation 12.5
|
-2.3 U/L
Standard Deviation 13.3
|
|
Change in Biochemistry: Amylase
Week 52: Change from baseline
|
-0.7 U/L
Standard Deviation 12.1
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Biochemistry: Lipase
Week 0: Baseline
|
55.4 U/L
Standard Deviation 26.1
|
57.3 U/L
Standard Deviation 28.7
|
|
Change in Biochemistry: Lipase
Week 26: Change from baseline
|
-1.4 U/L
Standard Deviation 23.4
|
-3.3 U/L
Standard Deviation 26.7
|
|
Change in Biochemistry: Lipase
Week 52: Change from baseline
|
-1.0 U/L
Standard Deviation 22.0
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Haemoglobin
Week 0: Baseline
|
14.65 g/dL
Standard Deviation 1.26
|
14.56 g/dL
Standard Deviation 1.35
|
|
Change in Haematology: Haemoglobin
Week 26: Change from baseline
|
-0.00 g/dL
Standard Deviation 0.67
|
0.04 g/dL
Standard Deviation 0.57
|
|
Change in Haematology: Haemoglobin
Week 52: Change from baseline
|
-0.00 g/dL
Standard Deviation 0.76
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26, Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in haematocrit was evaluated after 26 weeks and 52 weeks of treatment, respectively. Haematocrit is the ratio of the volume of red blood cells to the total volume of blood.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Haematocrit
Week 0: Baseline
|
44.86 % of red blood cell
Standard Deviation 3.79
|
44.65 % of red blood cell
Standard Deviation 4.03
|
|
Change in Haematology: Haematocrit
Week 26: Change from baseline
|
-0.22 % of red blood cell
Standard Deviation 2.26
|
-0.06 % of red blood cell
Standard Deviation 1.90
|
|
Change in Haematology: Haematocrit
Week 52: Change from baseline
|
-0.49 % of red blood cell
Standard Deviation 2.39
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Thrombocytes
Week 0: Baseline
|
229.1 10^9 cells/L
Standard Deviation 47.4
|
231.0 10^9 cells/L
Standard Deviation 57.6
|
|
Change in Haematology: Thrombocytes
Week 26: Change from baseline
|
0.8 10^9 cells/L
Standard Deviation 27.4
|
-1.5 10^9 cells/L
Standard Deviation 24.2
|
|
Change in Haematology: Thrombocytes
Week 52: Change from baseline
|
3.4 10^9 cells/L
Standard Deviation 24.9
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Erythrocytes
Week 0: Baseline
|
4.87 10^12 cells/L
Standard Deviation 0.41
|
4.89 10^12 cells/L
Standard Deviation 0.43
|
|
Change in Haematology: Erythrocytes
Week 26: Change from baseline
|
-0.02 10^12 cells/L
Standard Deviation 0.24
|
-0.00 10^12 cells/L
Standard Deviation 0.20
|
|
Change in Haematology: Erythrocytes
Week 52: Change from baseline
|
-0.04 10^12 cells/L
Standard Deviation 0.25
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Leukocytes
Week 52: Change from baseline
|
0.09 10^9 cells/L
Standard Deviation 1.44
|
—
|
|
Change in Haematology: Leukocytes
Week 0: Baseline
|
6.55 10^9 cells/L
Standard Deviation 1.71
|
6.53 10^9 cells/L
Standard Deviation 1.58
|
|
Change in Haematology: Leukocytes
Week 26: Change from baseline
|
0.09 10^9 cells/L
Standard Deviation 1.15
|
-0.08 10^9 cells/L
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Week 0, Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Eosinophils
Week 0: Baseline
|
0.182 10^9 cells/L
Standard Deviation 0.143
|
0.167 10^9 cells/L
Standard Deviation 0.158
|
|
Change in Haematology: Eosinophils
Week 26: Change from baseline
|
0.001 10^9 cells/L
Standard Deviation 0.118
|
-0.016 10^9 cells/L
Standard Deviation 0.104
|
|
Change in Haematology: Eosinophils
Week 52: Change from baseline
|
-0.008 10^9 cells/L
Standard Deviation 0.108
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Neutrophils
Week 0: Baseline
|
3.967 10^9 cells/L
Standard Deviation 1.337
|
3.975 10^9 cells/L
Standard Deviation 1.236
|
|
Change in Haematology: Neutrophils
Week 26: Change from baseline
|
0.054 10^9 cells/L
Standard Deviation 1.029
|
-0.088 10^9 cells/L
Standard Deviation 0.941
|
|
Change in Haematology: Neutrophils
Week 52: Change from baseline
|
0.062 10^9 cells/L
Standard Deviation 1.239
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Basophils
Week 52: Change from baseline
|
0.000 10^9 cells/L
Standard Deviation 0.016
|
—
|
|
Change in Haematology: Basophils
Week 0: Baseline
|
0.024 10^9 cells/L
Standard Deviation 0.013
|
0.026 10^9 cells/L
Standard Deviation 0.013
|
|
Change in Haematology: Basophils
Week 26: Change from baseline
|
0.004 10^9 cells/L
Standard Deviation 0.017
|
0.000 10^9 cells/L
Standard Deviation 0.016
|
SECONDARY outcome
Timeframe: Week 0, Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Monocytes
Week 0: Baseline
|
0.341 10^9 cells/L
Standard Deviation 0.133
|
0.326 10^9 cells/L
Standard Deviation 0.120
|
|
Change in Haematology: Monocytes
Week 26: Change from baseline
|
0.001 10^9 cells/L
Standard Deviation 0.101
|
-0.000 10^9 cells/L
Standard Deviation 0.104
|
|
Change in Haematology: Monocytes
Week 52: Change from baseline
|
0.019 10^9 cells/L
Standard Deviation 0.153
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Haematology: Lymphocytes
Week 0: Baseline
|
2.034 10^9 cells/L
Standard Deviation 0.561
|
2.037 10^9 cells/L
Standard Deviation 0.583
|
|
Change in Haematology: Lymphocytes
Week 26: Change from baseline
|
0.032 10^9 cells/L
Standard Deviation 0.364
|
0.022 10^9 cells/L
Standard Deviation 0.389
|
|
Change in Haematology: Lymphocytes
Week 52: Change from baseline
|
0.014 10^9 cells/L
Standard Deviation 0.347
|
—
|
SECONDARY outcome
Timeframe: Week 0 and Week 26 and Week 52Population: Safety analysis set, which included all subjects receiving at least one dose of liraglutide. 'Liraglutide 0.9 mg treatment arm' is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.
Reported results are number of subjects with low, normal or high calcitonin values at week 0, week 26 and week 52. Number of subjects analyzed = number of subjects contributed to the analysis for individual time point. Calcitonin values were categorised as low, normal or high.
Outcome measures
| Measure |
Liraglutide 1.8 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 Participants
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Change in Calcitonin
Week 0: Low
|
0 Participants
|
0 Participants
|
|
Change in Calcitonin
Week 0: Normal
|
229 Participants
|
229 Participants
|
|
Change in Calcitonin
Week 0: High
|
4 Participants
|
3 Participants
|
|
Change in Calcitonin
Week 26: Low
|
0 Participants
|
0 Participants
|
|
Change in Calcitonin
Week 26: Normal
|
228 Participants
|
231 Participants
|
|
Change in Calcitonin
Week 26: High
|
5 Participants
|
2 Participants
|
|
Change in Calcitonin
Week 52: Low
|
0 Participants
|
—
|
|
Change in Calcitonin
Week 52: Normal
|
230 Participants
|
—
|
|
Change in Calcitonin
Week 52: High
|
3 Participants
|
—
|
Adverse Events
Liraglutide 1.8 mg
Liraglutide 0.9 mg
Serious adverse events
| Measure |
Liraglutide 1.8 mg
n=233 participants at risk
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 participants at risk
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.86%
2/233 • Number of events 2 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Eye disorders
Cataract
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Investigations
Prostatic specific antigen increased
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vagina
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.43%
1/233 • Number of events 1 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
0.00%
0/233 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
Other adverse events
| Measure |
Liraglutide 1.8 mg
n=233 participants at risk
Subjects received liraglutide once daily s.c. injections for 52 weeks (26-week main + 26-week extension treatment period). After the 12-week run-in period, liraglutide dose was escalated from 0.9 mg/day to 1.2 mg/day for one week, followed by a weekly dose escalation of 0.3 mg to a maximum dose of 1.8 mg/day. Subjects continued liraglutide 1.8 mg/day till week 52.
|
Liraglutide 0.9 mg
n=233 participants at risk
Subjects received liraglutide once daily s.c. injections for 26 weeks (main treatment period). After the 12-week run-in period, subjects continued their liraglutide treatment unchanged (i.e., 0.9 mg/day) till week 26.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.3%
17/233 • Number of events 19 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
2.1%
5/233 • Number of events 5 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Eye disorders
Diabetic retinopathy
|
9.9%
23/233 • Number of events 24 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
7.3%
17/233 • Number of events 17 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
28.3%
66/233 • Number of events 94 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
18.9%
44/233 • Number of events 52 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
|
Investigations
Lipase increased
|
5.6%
13/233 • Number of events 13 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
2.6%
6/233 • Number of events 6 • Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).
All presented adverse events are treatment emergent (i.e., TEAEs). A TEAE was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Results are based on the safety analysis set, which included all subjects receiving at least one dose of liraglutide.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER