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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.

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ClinicalTrials.gov Identifier: NCT02505334
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : June 25, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Intervention Drug: liraglutide
Enrollment 635
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description 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. 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.
Period Title: Main Treatment Period
Started 233 233
Completed 218 194
Not Completed 15 39
Reason Not Completed
Adverse Event             3             3
Lack of Efficacy             7             17
Protocol Violation             0             1
Withdrawal by Subject             1             8
Unclassified             4             10
Period Title: Extension Treatment Period
Started 212 [1] 0 [2]
Completed 194 0
Not Completed 18 0
Reason Not Completed
Adverse Event             5             0
Lack of Efficacy             4             0
Withdrawal by Subject             6             0
Unclassified             3             0
[1]
6 subjects withdrew from the trial after the main period and prior to entering the extension period
[2]
This treatment arm is not considered for this period as the subjects were treated for 26 weeks
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 233 233 466
Hide Baseline Analysis Population Description
Full analysis set (FAS), which included all randomised subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 233 participants 233 participants 466 participants
55.07  (10.27) 54.96  (10.61) 55.01  (10.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants 233 participants 466 participants
Female
77
  33.0%
68
  29.2%
145
  31.1%
Male
156
  67.0%
165
  70.8%
321
  68.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants 233 participants 466 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
233
 100.0%
233
 100.0%
466
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Glycosylated haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage (%) of HbA1c
Number Analyzed 233 participants 233 participants 466 participants
8.14  (1.02) 8.10  (0.87) 8.12  (0.95)
1.Primary Outcome
Title Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
Hide Description 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.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, which included all randomised subjects. Missing values were imputed using the last observation carried forward (LOCF) method.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Least Squares Mean (Standard Error)
Unit of Measure: Percentage (%) of HbA1c
-0.23  (0.06) 0.17  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide 0.9 mg
Comments Missing data was imputed using the LOCF method. The change from baseline in the response after 26 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline response as a covariate.
Type of Statistical Test Superiority
Comments Superiority of liraglutide 1.8 mg/day vs. liraglutide 0.9 mg/day was to be considered confirmed if the 95% confidence interval for the treatment difference (liraglutide 1.8 mg/day minus liraglutide 0.9 mg/day) for change from baseline in HbA1c (% of HbA1c) was entirely below 0%, equivalent to a one-sided test with significance level of 2.5%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.55 to -0.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in HbA1c (Week 52)
Hide Description Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 233
Mean (Standard Deviation)
Unit of Measure: Percentage (%) of HbA1c
Week 0: Baseline 8.14  (1.02)
Week 52: Change from baseline -0.09  (1.05)
3.Secondary Outcome
Title Responder for HbA1c Below 7.0% (53 mmol/Mol)
Hide Description Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Count of Participants
Unit of Measure: Participants
Week 26 Number Analyzed 233 participants 233 participants
53
  22.7%
18
   7.7%
Week 52 Number Analyzed 233 participants 0 participants
45
  19.3%
4.Secondary Outcome
Title Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Hide Description 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.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Count of Participants
Unit of Measure: Participants
Week 26 Number Analyzed 233 participants 233 participants
18
   7.7%
5
   2.1%
Week 52 Number Analyzed 233 participants 0 participants
16
   6.9%
5.Secondary Outcome
Title Responder for HbA1c Below 7.0% Without Weight Gain
Hide Description 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.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Count of Participants
Unit of Measure: Participants
Week 26 Number Analyzed 233 participants 233 participants
36
  15.5%
13
   5.6%
Week 52 Number Analyzed 233 participants 0 participants
35
  15.0%
6.Secondary Outcome
Title Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Hide Description 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’
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Count of Participants
Unit of Measure: Participants
Week 26 Number Analyzed 233 participants 233 participants
53
  22.7%
18
   7.7%
Week 52 Number Analyzed 233 participants 0 participants
45
  19.3%
7.Secondary Outcome
Title Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Hide Description

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.
Time Frame Week 0 and Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0: Before breakfast Number Analyzed 232 participants 232 participants
181.8  (42.8) 177.1  (43.4)
Week 0: 90 minutes after start of breakfast Number Analyzed 230 participants 230 participants
262.6  (65.0) 266.5  (70.0)
Week 0: Before lunch Number Analyzed 232 participants 230 participants
169.5  (57.7) 177.6  (61.7)
Week 0: 90 minutes after start of lunch Number Analyzed 231 participants 230 participants
253.1  (64.5) 252.2  (63.5)
Week 0: Before dinner Number Analyzed 231 participants 230 participants
173.4  (59.2) 169.7  (56.5)
Week 0: 90 minutes after start of dinner Number Analyzed 232 participants 229 participants
254.3  (66.2) 249.5  (63.2)
Week 0: At bedtime Number Analyzed 230 participants 228 participants
226.1  (67.4) 217.8  (58.7)
Week 26: Before breakfast Number Analyzed 232 participants 233 participants
171.7  (39.6) 178.2  (44.4)
Week 26: 90 minutes after start of breakfast Number Analyzed 232 participants 233 participants
247.2  (64.6) 258.2  (63.7)
Week 26: Before lunch Number Analyzed 231 participants 232 participants
161.2  (51.0) 177.0  (57.9)
Week 26: 90 minutes after start of lunch Number Analyzed 232 participants 233 participants
234.7  (63.3) 255.3  (66.7)
Week 26: Before dinner Number Analyzed 232 participants 233 participants
162.3  (47.5) 168.6  (57.5)
Week 26: 90 minutes after start of dinner Number Analyzed 232 participants 233 participants
233.3  (60.1) 251.5  (64.9)
Week 26: At bedtime Number Analyzed 231 participants 232 participants
205.6  (58.6) 220.5  (68.8)
Week 52: Before breakfast Number Analyzed 232 participants 0 participants
176.1  (43.2)
Week 52: 90 minutes after start of breakfast Number Analyzed 229 participants 0 participants
251.1  (69.1)
Week 52: Before lunch Number Analyzed 231 participants 0 participants
169.6  (59.7)
Week 52: 90 minutes after start of lunch Number Analyzed 231 participants 0 participants
243.3  (63.9)
Week 52: Before dinner Number Analyzed 232 participants 0 participants
164.3  (50.8)
Week 52: 90 minutes after start of dinner Number Analyzed 230 participants 0 participants
240.5  (65.8)
Week 52: At bedtime Number Analyzed 230 participants 0 participants
207.9  (66.7)
8.Secondary Outcome
Title Change in SMBG 7-point Profile: Mean of 7-point Profile
Hide Description Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (week 0) Number Analyzed 232 participants 233 participants
217.9  (46.7) 217.7  (46.8)
Change from baseline: week 26 Number Analyzed 232 participants 233 participants
-14.5  (39.0) -0.6  (45.0)
Change from baseline: week 52 Number Analyzed 232 participants 0 participants
-8.9  (43.7)
9.Secondary Outcome
Title Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
Hide Description 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.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0: Baseline Number Analyzed 232 participants 232 participants
81.7  (38.7) 81.6  (38.6)
Week 26: Change from baseline Number Analyzed 232 participants 232 participants
-8.4  (43.8) -1.5  (39.5)
Week 52: Change from baseline Number Analyzed 232 participants 0 participants
-6.3  (44.4)
10.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG)
Hide Description Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0: Baseline Number Analyzed 233 participants 233 participants
172.5  (38.7) 172.0  (38.3)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-8.4  (36.7) 1.0  (33.7)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-1.2  (39.0)
11.Secondary Outcome
Title Change in Waist Circumference
Hide Description Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: Centimeter (cm)
Week 0: Baseline Number Analyzed 233 participants 233 participants
93.68  (11.75) 93.82  (11.50)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.44  (3.04) -0.73  (3.03)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-1.07  (3.64)
12.Secondary Outcome
Title Change in Body Weight
Hide Description Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: Kilogram (kg)
Week 0: Baseline Number Analyzed 233 participants 233 participants
74.67  (15.24) 75.13  (16.46)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.77  (2.01) -0.95  (2.19)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-1.05  (2.26)
13.Secondary Outcome
Title Change in Body Mass Index (BMI)
Hide Description Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Week 0: Baseline Number Analyzed 233 participants 233 participants
27.34  (4.80) 27.20  (4.72)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.28  (0.72) -0.33  (0.78)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-0.39  (0.82)
14.Secondary Outcome
Title Change in Blood Pressure (Systolic and Diastolic)
Hide Description 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.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mmHg
Week 0: SBP, Baseline Number Analyzed 233 participants 233 participants
128.0  (13.1) 128.8  (13.1)
Week 26: SBP, change from baseline Number Analyzed 233 participants 233 participants
-1.7  (12.8) 0.4  (12.2)
Week 52: SBP, change from baseline Number Analyzed 233 participants 0 participants
-0.9  (12.5)
Week 0: DBP, Baseline Number Analyzed 233 participants 233 participants
79.6  (9.1) 80.3  (9.8)
Week 26: DBP, change from baseline Number Analyzed 233 participants 233 participants
-0.9  (8.7) 0.1  (7.8)
Week 52: DBP, change from baseline Number Analyzed 233 participants 0 participants
-0.6  (8.4)
15.Secondary Outcome
Title Fasting C-peptide
Hide Description Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Week 26 Number Analyzed 233 participants 233 participants
1.946
(41.9%)
1.853
(40.8%)
Week 52 Number Analyzed 233 participants 0 participants
1.906
(42.2%)
16.Secondary Outcome
Title Fasting Insulin
Hide Description Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pmol/L
Week 26 Number Analyzed 233 participants 233 participants
77.00
(70.9%)
70.91
(65.3%)
Week 52 Number Analyzed 233 participants 0 participants
77.31
(68.7%)
17.Secondary Outcome
Title Fasting Glucagon
Hide Description Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pmol/L
Week 26 Number Analyzed 233 participants 233 participants
22.5
(30.0%)
23.4
(26.8%)
Week 52 Number Analyzed 233 participants 0 participants
23.4
(30.2%)
18.Secondary Outcome
Title Proinsulin
Hide Description Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pmol/L
Week 26 Number Analyzed 233 participants 233 participants
15.638
(111.2%)
16.054
(101.8%)
Week 52 Number Analyzed 233 participants 0 participants
16.217
(107.4%)
19.Secondary Outcome
Title Proinsulin/Insulin
Hide Description Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Percentage (%) of proinsulin/insulin
Week 26 Number Analyzed 233 participants 233 participants
20.31
(70.7%)
22.64
(70.6%)
Week 52 Number Analyzed 233 participants 0 participants
20.98
(72.5%)
20.Secondary Outcome
Title Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Hide Description 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)].
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Percentage (%) of beta-cell function
Week 26 Number Analyzed 233 participants 233 participants
42.06
(73.0%)
35.54
(72.9%)
Week 52 Number Analyzed 233 participants 0 participants
40.03
(79.5%)
21.Secondary Outcome
Title Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Hide Description 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.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: HOMA-IR score
Week 26 Number Analyzed 233 participants 233 participants
4.388
(81.9%)
4.262
(73.5%)
Week 52 Number Analyzed 233 participants 0 participants
4.567
(77.5%)
22.Secondary Outcome
Title Total Cholesterol
Hide Description Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg/dL
Week 26 Number Analyzed 233 participants 233 participants
191.2
(17.6%)
194.5
(16.1%)
Week 52 Number Analyzed 233 participants 0 participants
190.6
(16.3%)
23.Secondary Outcome
Title Low Density Lipoprotein (LDL) Cholesterol
Hide Description LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg/dL
Week 26 Number Analyzed 233 participants 233 participants
103.4
(31.6%)
107.1
(27.8%)
Week 52 Number Analyzed 233 participants 0 participants
104.5
(26.2%)
24.Secondary Outcome
Title High Density Lipoprotein (HDL) Cholesterol
Hide Description HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg/dL
Week 26 Number Analyzed 233 participants 233 participants
52.7
(25.6%)
52.9
(26.3%)
Week 52 Number Analyzed 233 participants 0 participants
53.3
(24.7%)
25.Secondary Outcome
Title Very Low Density Lipoprotein (VLDL) Cholesterol
Hide Description VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg/dL
Week 26 Number Analyzed 233 participants 233 participants
26.8
(56.7%)
27.8
(49.4%)
Week 52 Number Analyzed 233 participants 0 participants
25.9
(55.2%)
26.Secondary Outcome
Title Triglycerides
Hide Description Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg/dL
Week 26 Number Analyzed 233 participants 233 participants
135.4
(60.1%)
142.3
(54.9%)
Week 52 Number Analyzed 233 participants 0 participants
130.4
(57.0%)
27.Secondary Outcome
Title Free Fatty Acids
Hide Description Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg/dL
Week 26 Number Analyzed 233 participants 233 participants
12.56
(47.4%)
12.99
(43.9%)
Week 52 Number Analyzed 233 participants 0 participants
12.19
(44.3%)
28.Secondary Outcome
Title Number of Treatment Emergent Adverse Events
Hide Description 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’.
Time Frame Weeks 0-26 and Weeks 0-52
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Number
Unit of Measure: Events
Weeks 0-26 Number Analyzed 233 participants 233 participants
365 266
Weeks 0-52 Number Analyzed 233 participants 0 participants
588
29.Secondary Outcome
Title Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Hide Description 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’.
Time Frame Weeks 0-26 and Weeks 0-52
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Number
Unit of Measure: Episodes
Weeks 0-26 Number Analyzed 233 participants 233 participants
0 0
Weeks 0-52 Number Analyzed 233 participants 0 participants
0
30.Secondary Outcome
Title Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Hide Description 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’.
Time Frame Weeks 0-26 and Weeks 0-52
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Number
Unit of Measure: Episodes
Weeks 0-26 Number Analyzed 233 participants 233 participants
0 0
Weeks 0-52 Number Analyzed 233 participants 0 participants
0
31.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Hide Description

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’.
Time Frame Weeks 0-26 and Weeks 0-52
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Number
Unit of Measure: Episodes
Weeks 0-26: Severe hypoglycaemia Number Analyzed 233 participants 233 participants
0 0
Weeks 0-26: Documented symptomatic hypoglycaemia Number Analyzed 233 participants 233 participants
0 0
Weeks 0-26: Asymptomatic hypoglycaemia Number Analyzed 233 participants 233 participants
2 1
Weeks 0-26: Probable symptomatic hypoglycaemia Number Analyzed 233 participants 233 participants
3 1
Weeks 0-26: Pseudo-hypoglycaemia Number Analyzed 233 participants 233 participants
2 1
Weeks 0-52: Severe hypoglycaemia Number Analyzed 233 participants 0 participants
0
Weeks 0-52: Documented symptomatic hypoglycaemia Number Analyzed 233 participants 0 participants
0
Weeks 0-52: Asymptomatic hypoglycaemia Number Analyzed 233 participants 0 participants
3
Weeks 0-52: Probable symptomatic hypoglycaemia Number Analyzed 233 participants 0 participants
4
Weeks 0-52: Pseudo-hypoglycaemia Number Analyzed 233 participants 0 participants
2
32.Secondary Outcome
Title Change in Pulse
Hide Description Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: Beats/minute
Week 0: Baseline Number Analyzed 233 participants 233 participants
80.2  (9.8) 80.8  (10.4)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.8  (7.8) 0.2  (7.9)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.2  (8.1)
33.Secondary Outcome
Title Change in Physical Examination
Hide Description

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
Time Frame Week 0 and Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Count of Participants
Unit of Measure: Participants
Cardiovascular system: Wk 0: Normal Number Analyzed 233 participants 233 participants
229
  98.3%
230
  98.7%
Cardiovascular system: Wk 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
3
   1.3%
0
   0.0%
Cardiovascular system: Wk 0: Abnormal, CS Number Analyzed 233 participants 233 participants
1
   0.4%
3
   1.3%
Cardiovascular system: Wk 26: Normal Number Analyzed 233 participants 233 participants
230
  98.7%
229
  98.3%
Cardiovascular system: Wk 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
2
   0.9%
0
   0.0%
Cardiovascular system: Week 26: Abnormal, CS Number Analyzed 233 participants 233 participants
1
   0.4%
4
   1.7%
Cardiovascular system: Wk 52: Normal Number Analyzed 233 participants 0 participants
227
  97.4%
Cardiovascular system: Wk 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
4
   1.7%
Cardiovascular system: Wk 52: Abnormal, CS Number Analyzed 233 participants 0 participants
2
   0.9%
Central and PNS: Wk 0: Normal Number Analyzed 233 participants 233 participants
232
  99.6%
229
  98.3%
Central and PNS: Wk 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
1
   0.4%
Central and PNS: Wk 0: Abnormal, CS Number Analyzed 233 participants 233 participants
1
   0.4%
3
   1.3%
Central and PNS: Wk 26: Normal Number Analyzed 233 participants 233 participants
231
  99.1%
229
  98.3%
Central and PNS: Wk 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
1
   0.4%
Central and PNS: Wk 26: Abnormal, CS Number Analyzed 233 participants 233 participants
2
   0.9%
3
   1.3%
Central and PNS: Wk 52: Normal Number Analyzed 233 participants 0 participants
232
  99.6%
Central and PNS: Wk 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
0
   0.0%
Central and PNS: Wk 52: Abnormal, CS Number Analyzed 233 participants 0 participants
1
   0.4%
GI system including mouth: Wk 0: Normal Number Analyzed 233 participants 233 participants
227
  97.4%
226
  97.0%
GI system including mouth: Wk 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
4
   1.7%
GI system including mouth: Wk 0: Abnormal, CS Number Analyzed 233 participants 233 participants
6
   2.6%
3
   1.3%
GI system including mouth: Wk 26: Normal Number Analyzed 233 participants 233 participants
227
  97.4%
226
  97.0%
GI system including mouth: Wk 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
3
   1.3%
GI system including mouth: Wk 26: Abnormal, CS Number Analyzed 233 participants 233 participants
6
   2.6%
4
   1.7%
GI system including mouth: Wk 52: Normal Number Analyzed 233 participants 0 participants
226
  97.0%
GI system including mouth: Wk 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
2
   0.9%
GI system including mouth: Wk 52: Abnormal, CS Number Analyzed 233 participants 0 participants
5
   2.1%
General appearance: Wk 0: Normal Number Analyzed 233 participants 233 participants
229
  98.3%
232
  99.6%
General appearance: Wk 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
4
   1.7%
1
   0.4%
General appearance: Wk 0: Abnormal, CS Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
General appearance: Wk 26: Normal Number Analyzed 233 participants 233 participants
229
  98.3%
233
 100.0%
General appearance: Wk 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
4
   1.7%
0
   0.0%
General appearance: Wk 26: Abnormal, CS Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
General appearance: Wk 52: Normal Number Analyzed 233 participants 0 participants
229
  98.3%
General appearance: Wk 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
4
   1.7%
General appearance: Wk 52: Abnormal, CS Number Analyzed 233 participants 0 participants
0
   0.0%
Head,ears,eyes,nose,throat,neck: Wk0:Normal Number Analyzed 233 participants 233 participants
225
  96.6%
226
  97.0%
Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,NCS Number Analyzed 233 participants 233 participants
3
   1.3%
2
   0.9%
Head,ears,eyes,nose,throat,neck: Wk0:Abnormal,CS Number Analyzed 233 participants 233 participants
5
   2.1%
5
   2.1%
Head,ears,eyes,nose,throat,neck: Wk26:Normal Number Analyzed 233 participants 233 participants
225
  96.6%
228
  97.9%
Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,NCS Number Analyzed 233 participants 233 participants
4
   1.7%
1
   0.4%
Head,ears,eyes,nose,throat,neck: Wk26:Abnormal,CS Number Analyzed 233 participants 233 participants
4
   1.7%
4
   1.7%
Head,ears,eyes,nose,throat,neck: Wk52:Normal Number Analyzed 233 participants 0 participants
223
  95.7%
Head,ears,eyes,nose,throat,neck: Wk52:Abnormal,NCS Number Analyzed 233 participants 0 participants
5
   2.1%
Head,ears,eyes,nose,throat,neck: Wk52:Abnormal,CS Number Analyzed 233 participants 0 participants
5
   2.1%
Lymph node palpation: Wk 0: Normal Number Analyzed 233 participants 233 participants
233
 100.0%
233
 100.0%
Lymph node palpation: Wk 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
Lymph node palpation: Wk 0: Abnormal, CS Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
Lymph node palpation: Wk 26: Normal Number Analyzed 233 participants 233 participants
233
 100.0%
233
 100.0%
Lymph node palpation: Wk 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
Lymph node palpation: Wk 26: Abnormal, CS Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
Lymph node palpation: Wk 52: Normal Number Analyzed 233 participants 0 participants
233
 100.0%
Lymph node palpation: Wk 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
0
   0.0%
Lymph node palpation: Wk 52: Abnormal, CS Number Analyzed 233 participants 0 participants
0
   0.0%
Musculoskeletal system: Wk 0: Normal Number Analyzed 233 participants 233 participants
226
  97.0%
231
  99.1%
Musculoskeletal system: Wk 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
4
   1.7%
0
   0.0%
Musculoskeletal system: Wk 0: Abnormal, CS Number Analyzed 233 participants 233 participants
3
   1.3%
2
   0.9%
Musculoskeletal system: Wk 26: Normal Number Analyzed 233 participants 233 participants
224
  96.1%
230
  98.7%
Musculoskeletal system: Wk 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
5
   2.1%
0
   0.0%
Musculoskeletal system: Wk 26: Abnormal, CS Number Analyzed 233 participants 233 participants
4
   1.7%
3
   1.3%
Musculoskeletal system: Wk 52: Normal Number Analyzed 233 participants 0 participants
224
  96.1%
Musculoskeletal system: Wk 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
5
   2.1%
Musculoskeletal system: Wk 52: Abnormal, CS Number Analyzed 233 participants 0 participants
4
   1.7%
Respiratory system: Wk 0: Normal Number Analyzed 233 participants 233 participants
233
 100.0%
232
  99.6%
Respiratory system: Wk 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
1
   0.4%
Respiratory system: Wk 0: Abnormal, CS Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
Respiratory system: Wk 26: Normal Number Analyzed 233 participants 233 participants
232
  99.6%
232
  99.6%
Respiratory system: Wk 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
1
   0.4%
Respiratory system: Wk 26: Abnormal, CS Number Analyzed 233 participants 233 participants
1
   0.4%
0
   0.0%
Respiratory system: Wk 52: Normal Number Analyzed 233 participants 0 participants
232
  99.6%
Respiratory system: Wk 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
0
   0.0%
Respiratory system: Wk 52: Abnormal, CS Number Analyzed 233 participants 0 participants
1
   0.4%
Skin: Wk 0: Normal Number Analyzed 233 participants 233 participants
225
  96.6%
223
  95.7%
Skin: Wk 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
4
   1.7%
3
   1.3%
Skin: Wk 0: Abnormal, CS Number Analyzed 233 participants 233 participants
4
   1.7%
7
   3.0%
Skin: Wk 26: Normal Number Analyzed 233 participants 233 participants
218
  93.6%
222
  95.3%
Skin: Wk 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
4
   1.7%
4
   1.7%
Skin: Wk 26: Abnormal, CS Number Analyzed 233 participants 233 participants
11
   4.7%
7
   3.0%
Skin: Wk 52: Normal Number Analyzed 233 participants 0 participants
224
  96.1%
Skin: Wk 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
4
   1.7%
Skin: Wk 52: Abnormal, CS Number Analyzed 233 participants 0 participants
5
   2.1%
Thyroid gland: Wk 0: Normal Number Analyzed 233 participants 233 participants
232
  99.6%
232
  99.6%
Thyroid gland: Wk 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
Thyroid gland: Wk 0: Abnormal, CS Number Analyzed 233 participants 233 participants
1
   0.4%
1
   0.4%
Thyroid gland: Wk 26: Normal Number Analyzed 233 participants 233 participants
232
  99.6%
232
  99.6%
Thyroid gland: Wk 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
Thyroid gland: Wk 26: Abnormal, CS Number Analyzed 233 participants 233 participants
1
   0.4%
1
   0.4%
Thyroid gland: Wk 52: Normal Number Analyzed 233 participants 0 participants
232
  99.6%
Thyroid gland: Wk 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
0
   0.0%
Thyroid gland: Wk 52: Abnormal, CS Number Analyzed 233 participants 0 participants
1
   0.4%
34.Secondary Outcome
Title Change in Eye Examination
Hide Description 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.
Time Frame Week 0 and Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0: Left eye - Normal Number Analyzed 233 participants 233 participants
183
  78.5%
176
  75.5%
Week 0: Left eye - Abnormal, NCS Number Analyzed 233 participants 233 participants
15
   6.4%
13
   5.6%
Week 0: Left eye - Abnormal, CS Number Analyzed 233 participants 233 participants
35
  15.0%
44
  18.9%
Week 26: Left eye - Normal Number Analyzed 233 participants 233 participants
178
  76.4%
178
  76.4%
Week 26: Left eye - Abnormal, NCS Number Analyzed 233 participants 233 participants
18
   7.7%
15
   6.4%
Week 26: Left eye - Abnormal, CS Number Analyzed 233 participants 233 participants
37
  15.9%
40
  17.2%
Week 52: Left eye - Normal Number Analyzed 233 participants 0 participants
181
  77.7%
Week 52: Left eye - Abnormal, NCS Number Analyzed 233 participants 0 participants
16
   6.9%
Week 52: Left eye - Abnormal, CS Number Analyzed 233 participants 0 participants
36
  15.5%
Week 0: Right eye - Normal Number Analyzed 233 participants 233 participants
183
  78.5%
180
  77.3%
Week 0: Right eye - Abnormal, NCS Number Analyzed 233 participants 233 participants
14
   6.0%
11
   4.7%
Week 0: Right eye - Abnormal, CS Number Analyzed 233 participants 233 participants
36
  15.5%
42
  18.0%
Week 26: Right eye - Normal Number Analyzed 233 participants 233 participants
176
  75.5%
180
  77.3%
Week 26: Right eye - Abnormal, NCS Number Analyzed 233 participants 233 participants
19
   8.2%
14
   6.0%
Week 26: Right eye - Abnormal, CS Number Analyzed 233 participants 233 participants
38
  16.3%
39
  16.7%
Week 52: Right eye - Normal Number Analyzed 233 participants 0 participants
177
  76.0%
Week 52: Right eye - Abnormal, NCS Number Analyzed 233 participants 0 participants
18
   7.7%
Week 52: Right eye - Abnormal, CS Number Analyzed 233 participants 0 participants
38
  16.3%
35.Secondary Outcome
Title Change in Electrocardiogram (ECG)
Hide Description 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.
Time Frame Week 0 and Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0: Normal Number Analyzed 233 participants 233 participants
202
  86.7%
196
  84.1%
Week 0: Abnormal, NCS Number Analyzed 233 participants 233 participants
31
  13.3%
35
  15.0%
Week 0: Abnormal, CS Number Analyzed 233 participants 233 participants
0
   0.0%
2
   0.9%
Week 26: Normal Number Analyzed 233 participants 233 participants
205
  88.0%
204
  87.6%
Week 26: Abnormal, NCS Number Analyzed 233 participants 233 participants
26
  11.2%
26
  11.2%
Week 26: Abnormal, CS Number Analyzed 233 participants 233 participants
2
   0.9%
3
   1.3%
Week 52: Normal Number Analyzed 233 participants 0 participants
203
  87.1%
Week 52: Abnormal, NCS Number Analyzed 233 participants 0 participants
28
  12.0%
Week 52: Abnormal, CS Number Analyzed 233 participants 0 participants
2
   0.9%
36.Secondary Outcome
Title Change in Biochemistry: Creatinine
Hide Description Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0: Baseline Number Analyzed 233 participants 233 participants
0.802  (0.144) 0.822  (0.164)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.018  (0.070) 0.011  (0.080)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.025  (0.078)
37.Secondary Outcome
Title Change in Biochemistry: eGFR
Hide Description 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.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
Week 0: Baseline Number Analyzed 233 participants 233 participants
78.6  (9.5) 77.6  (10.7)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-1.5  (5.0) -1.0  (5.8)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-2.3  (5.6)
38.Secondary Outcome
Title Change in Biochemistry: Alanine Aminotransferase
Hide Description Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: U/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
32.7  (19.5) 34.2  (21.8)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.4  (12.0) -2.2  (13.9)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-2.4  (11.9)
39.Secondary Outcome
Title Change in Biochemistry: Aspartate Aminotransferase
Hide Description Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: U/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
26.5  (12.8) 26.9  (13.9)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.2  (9.9) -1.0  (8.6)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-1.2  (8.9)
40.Secondary Outcome
Title Change in Biochemistry: Alkaline Phosphatase
Hide Description Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: U/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
72.5  (20.6) 74.1  (22.1)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.6  (9.8) 2.0  (12.4)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
2.1  (11.1)
41.Secondary Outcome
Title Change in Biochemistry: Sodium
Hide Description Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
140.2  (1.9) 140.2  (1.9)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.1  (1.8) 0.2  (2.0)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.3  (1.8)
42.Secondary Outcome
Title Change in Biochemistry: Potassium
Hide Description Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
4.40  (0.34) 4.38  (0.34)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.01  (0.32) -0.02  (0.29)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.00  (0.31)
43.Secondary Outcome
Title Change in Biochemistry: Albumin
Hide Description Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: g/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
44.7  (2.5) 45.1  (2.2)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.2  (2.1) -0.2  (1.9)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-0.2  (2.2)
44.Secondary Outcome
Title Change in Biochemistry: Total Bilirubin
Hide Description Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0: Baseline Number Analyzed 233 participants 233 participants
0.52  (0.29) 0.53  (0.25)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.04  (0.25) 0.04  (0.24)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.06  (0.23)
45.Secondary Outcome
Title Change in Biochemistry: Urea
Hide Description Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0: Baseline Number Analyzed 233 participants 233 participants
13.5  (3.2) 14.0  (3.7)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.3  (3.0) -0.0  (3.3)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.7  (2.8)
46.Secondary Outcome
Title Change in Biochemistry: Creatine Kinase
Hide Description Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: U/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
117.3  (61.8) 129.3  (100.3)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
5.2  (50.9) -5.2  (96.3)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
7.5  (54.8)
47.Secondary Outcome
Title Change in Biochemistry: Calcium
Hide Description Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0: Baseline Number Analyzed 233 participants 233 participants
9.66  (0.41) 9.66  (0.37)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.01  (0.41) 0.01  (0.39)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.01  (0.41)
48.Secondary Outcome
Title Change in Biochemistry: Albumin Corrected Calcium
Hide Description Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 0: Baseline Number Analyzed 233 participants 233 participants
9.28  (0.35) 9.26  (0.32)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.00  (0.37) 0.02  (0.35)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.02  (0.36)
49.Secondary Outcome
Title Change in Biochemistry: Amylase
Hide Description Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: U/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
62.3  (23.1) 61.1  (22.5)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.9  (12.5) -2.3  (13.3)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-0.7  (12.1)
50.Secondary Outcome
Title Change in Biochemistry: Lipase
Hide Description Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: U/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
55.4  (26.1) 57.3  (28.7)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-1.4  (23.4) -3.3  (26.7)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-1.0  (22.0)
51.Secondary Outcome
Title Change in Haematology: Haemoglobin
Hide Description Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: g/dL
Week 0: Baseline Number Analyzed 233 participants 233 participants
14.65  (1.26) 14.56  (1.35)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.00  (0.67) 0.04  (0.57)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-0.00  (0.76)
52.Secondary Outcome
Title Change in Haematology: Haematocrit
Hide Description 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.
Time Frame Week 0, Week 26, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: % of red blood cell
Week 0: Baseline Number Analyzed 233 participants 233 participants
44.86  (3.79) 44.65  (4.03)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.22  (2.26) -0.06  (1.90)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-0.49  (2.39)
53.Secondary Outcome
Title Change in Haematology: Thrombocytes
Hide Description Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
229.1  (47.4) 231.0  (57.6)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.8  (27.4) -1.5  (24.2)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
3.4  (24.9)
54.Secondary Outcome
Title Change in Haematology: Erythrocytes
Hide Description Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: 10^12 cells/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
4.87  (0.41) 4.89  (0.43)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
-0.02  (0.24) -0.00  (0.20)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-0.04  (0.25)
55.Secondary Outcome
Title Change in Haematology: Leukocytes
Hide Description Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
6.55  (1.71) 6.53  (1.58)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.09  (1.15) -0.08  (1.09)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.09  (1.44)
56.Secondary Outcome
Title Change in Haematology: Eosinophils
Hide Description Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
0.182  (0.143) 0.167  (0.158)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.001  (0.118) -0.016  (0.104)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
-0.008  (0.108)
57.Secondary Outcome
Title Change in Haematology: Neutrophils
Hide Description Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
3.967  (1.337) 3.975  (1.236)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.054  (1.029) -0.088  (0.941)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.062  (1.239)
58.Secondary Outcome
Title Change in Haematology: Basophils
Hide Description Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
0.024  (0.013) 0.026  (0.013)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.004  (0.017) 0.000  (0.016)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.000  (0.016)
59.Secondary Outcome
Title Change in Haematology: Monocytes
Hide Description Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
0.341  (0.133) 0.326  (0.120)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.001  (0.101) -0.000  (0.104)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.019  (0.153)
60.Secondary Outcome
Title Change in Haematology: Lymphocytes
Hide Description Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Time Frame Week 0, Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Week 0: Baseline Number Analyzed 233 participants 233 participants
2.034  (0.561) 2.037  (0.583)
Week 26: Change from baseline Number Analyzed 233 participants 233 participants
0.032  (0.364) 0.022  (0.389)
Week 52: Change from baseline Number Analyzed 233 participants 0 participants
0.014  (0.347)
61.Secondary Outcome
Title Change in Calcitonin
Hide Description 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.
Time Frame Week 0 and Week 26 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 233 233
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0: Low Number Analyzed 233 participants 232 participants
0
   0.0%
0
   0.0%
Week 0: Normal Number Analyzed 233 participants 232 participants
229
  98.3%
229
  98.7%
Week 0: High Number Analyzed 233 participants 232 participants
4
   1.7%
3
   1.3%
Week 26: Low Number Analyzed 233 participants 233 participants
0
   0.0%
0
   0.0%
Week 26: Normal Number Analyzed 233 participants 233 participants
228
  97.9%
231
  99.1%
Week 26: High Number Analyzed 233 participants 233 participants
5
   2.1%
2
   0.9%
Week 52: Low Number Analyzed 233 participants 0 participants
0
   0.0%
Week 52: Normal Number Analyzed 233 participants 0 participants
230
  98.7%
Week 52: High Number Analyzed 233 participants 0 participants
3
   1.3%
Time Frame 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).
Adverse Event Reporting Description 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.
 
Arm/Group Title Liraglutide 1.8 mg Liraglutide 0.9 mg
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Liraglutide 1.8 mg Liraglutide 0.9 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/233 (0.00%)      0/233 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Liraglutide 1.8 mg Liraglutide 0.9 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/233 (3.43%)      3/233 (1.29%)    
Eye disorders     
Cataract  1  1/233 (0.43%)  1 0/233 (0.00%)  0
Gastrointestinal disorders     
Pancreatitis acute  1  0/233 (0.00%)  0 1/233 (0.43%)  1
Injury, poisoning and procedural complications     
Tibia fracture  1  1/233 (0.43%)  1 0/233 (0.00%)  0
Upper limb fracture  1  1/233 (0.43%)  1 0/233 (0.00%)  0
Investigations     
Prostatic specific antigen increased  1  1/233 (0.43%)  1 0/233 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Rectal cancer  1  2/233 (0.86%)  2 0/233 (0.00%)  0
Squamous cell carcinoma of the vagina  1  1/233 (0.43%)  1 0/233 (0.00%)  0
Nervous system disorders     
Lacunar infarction  1  0/233 (0.00%)  0 1/233 (0.43%)  1
Renal and urinary disorders     
Calculus urinary  1  0/233 (0.00%)  0 1/233 (0.43%)  1
Respiratory, thoracic and mediastinal disorders     
Sleep apnoea syndrome  1  1/233 (0.43%)  1 0/233 (0.00%)  0
Surgical and medical procedures     
Large intestinal polypectomy  1  1/233 (0.43%)  1 0/233 (0.00%)  0
1
Term from vocabulary, MedDRA 20
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Liraglutide 1.8 mg Liraglutide 0.9 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   99/233 (42.49%)      65/233 (27.90%)    
Eye disorders     
Diabetic retinopathy  1  23/233 (9.87%)  24 17/233 (7.30%)  17
Gastrointestinal disorders     
Constipation  1  17/233 (7.30%)  19 5/233 (2.15%)  5
Infections and infestations     
Viral upper respiratory tract infection  1  66/233 (28.33%)  94 44/233 (18.88%)  52