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Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02918279
Recruitment Status : Completed
First Posted : September 28, 2016
Results First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Metabolism and Nutrition Disorder
Obesity
Interventions Drug: Liraglutide
Drug: Placebo
Enrollment 251
Recruitment Details This trial was conducted at 32 sites in 5 countries: Belgium (6 sites), Sweden (4 sites), Russia (8 sites), Mexico (2 sites) and the United States of America (USA - 12 sites). Additionally, 1 site in the USA was approved by the independent review board, but did not randomise any participant.
Pre-assignment Details This trial consisted of a 12-week run-in period, during which participants received counselling on healthy nutrition and physical activity. Completed numbers include participants who completed the trial without prematurely discontinuing the trial product and participants who discontinued the trial product but came for the week 82 follow-up visit.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by subcutaneous (s.c.; under the skin) injection in the abdomen, thigh or upper arm irrespective of the timing of meals. Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Period Title: Overall Study
Started 125 126
Full Analysis Set 125 126
Safety Analysis Set 125 126
Completed 112 103
Not Completed 13 23
Reason Not Completed
Lost to Follow-up             3             6
Withdrawal by Subject             5             15
Withdrawal by parent/guardian             2             1
Other             3             1
Arm/Group Title Liraglutide 3.0 mg Placebo Total
Hide Arm/Group Description Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals. Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals. Total of all reporting groups
Overall Number of Baseline Participants 125 126 251
Hide Baseline Analysis Population Description
Results are based on the full analysis set (FAS) which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 126 participants 251 participants
14.6  (1.6) 14.5  (1.6) 14.5  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Female
71
  56.8%
78
  61.9%
149
  59.4%
Male
54
  43.2%
48
  38.1%
102
  40.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Hispanic or Latino
32
  25.6%
24
  19.0%
56
  22.3%
Not Hispanic or Latino
93
  74.4%
102
  81.0%
195
  77.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
American Indian or Alaska Native
0
   0.0%
1
   0.8%
1
   0.4%
Asian
2
   1.6%
0
   0.0%
2
   0.8%
Black or African American
14
  11.2%
6
   4.8%
20
   8.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
White
105
  84.0%
115
  91.3%
220
  87.6%
Other
4
   3.2%
4
   3.2%
8
   3.2%
1.Primary Outcome
Title Change in BMI SDS (Week 0, Week 56)
Hide Description Change from baseline (week 0) in BMI SDS was evaluated at week 56. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the full analysis set (FAS) which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 113 105
Mean (Standard Deviation)
Unit of Measure: SDS score
-0.25  (0.51) -0.02  (0.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.37 to -0.08
Estimation Comments Liraglutide 3.0 mg - Placebo
2.Secondary Outcome
Title Percent of Subjects Achieving ≥5% Reduction in Baseline BMI
Hide Description Participants achieving more than or equal to 5% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame Weeks 30, 56 and 82
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Number
Unit of Measure: Percentage of participants
Week 30 (Yes) Number Analyzed 119 participants 116 participants
46.2 14.7
Week 30 (No) Number Analyzed 119 participants 116 participants
53.8 85.3
Week 56 (Yes) Number Analyzed 113 participants 105 participants
45.1 19.0
Week 56 (No) Number Analyzed 113 participants 105 participants
54.9 81.0
Week 82 (Yes) Number Analyzed 112 participants 102 participants
29.5 18.6
Week 82 (No) Number Analyzed 112 participants 102 participants
70.5 81.4
3.Secondary Outcome
Title Percent of Subjects Achieving ≥10% Reduction in Baseline BMI
Hide Description Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame Weeks 30, 56 and 82
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Number
Unit of Measure: Percentage of participants
Week 30 (Yes) Number Analyzed 119 participants 116 participants
24.4 5.2
Week 30 (No) Number Analyzed 119 participants 116 participants
75.6 94.8
Week 56 (Yes) Number Analyzed 113 participants 105 participants
29.2 8.6
Week 56 (No) Number Analyzed 113 participants 105 participants
70.8 91.4
Week 82 (Yes) Number Analyzed 112 participants 102 participants
18.8 10.8
Week 82 (No) Number Analyzed 112 participants 102 participants
81.3 89.2
4.Secondary Outcome
Title Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))
Hide Description Change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 82, and from week 56 to week 82. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the trial period, week 0-30 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30 or 82, respectively.
Time Frame (Week 0, week 30); (Week 0, week 82); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: SDS score
Change from week 0 to week 30 Number Analyzed 119 participants 116 participants
-0.26  (0.34) -0.04  (0.33)
Change from week 0 to week 82 Number Analyzed 112 participants 102 participants
-0.06  (0.53) 0.07  (0.66)
Change from week 56 to week 82 Number Analyzed 99 participants 98 participants
0.22  (0.28) 0.08  (0.27)
5.Secondary Outcome
Title Change in BMI
Hide Description Change in BMI was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Change from week 0 to week 30 Number Analyzed 119 participants 116 participants
-1.8  (2.1) -0.2  (2.2)
Change from week 0 to week 56 Number Analyzed 113 participants 105 participants
-1.6  (3.1) 0.1  (3.4)
Change from week 56 to week 82 Number Analyzed 99 participants 98 participants
1.5  (1.7) 0.7  (1.7)
6.Secondary Outcome
Title Change in Body Weight (kg)
Hide Description Change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: kg
Change from week 0 to week 30 Number Analyzed 119 participants 116 participants
-3.9  (6.1) 0.4  (6.6)
Change from week 0 to week 56 Number Analyzed 113 participants 105 participants
-2.7  (9.1) 2.1  (10.2)
Change from week 56 to week 82 Number Analyzed 99 participants 98 participants
4.7  (4.6) 2.4  (4.9)
7.Secondary Outcome
Title Change in Body Weight (%)
Hide Description Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: Percentage change
Change from week 0 to week 30 Number Analyzed 119 participants 116 participants
-4.3  (6.5) 0.4  (6.2)
Change from week 0 to week 56 Number Analyzed 113 participants 105 participants
-3.2  (9.4) 2.2  (9.5)
Change from week 56 to week 82 Number Analyzed 99 participants 98 participants
5.3  (5.7) 2.3  (4.9)
8.Secondary Outcome
Title Change in Body Weight (lb)
Hide Description Body weight was not analysed in pounds (lb). It was analysed for standard unit, 'kg' only.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Body weight was not analysed in pounds (lb).
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change in Waist Circumference
Hide Description Change in waist circumference was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: cm
Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
-4.63  (6.24) -2.01  (5.94)
Change from week 0 to week 56 Number Analyzed 100 participants 101 participants
-5.12  (7.87) -1.51  (8.20)
Change from week 56 to week 82 Number Analyzed 98 participants 98 participants
3.58  (4.30) 1.24  (5.60)
10.Secondary Outcome
Title Change in Waist-to-hip Circumference Ratio
Hide Description Change in waist-to-hip circumference ratio was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: Ratio
Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
-0.015  (0.042) -0.018  (0.042)
Change from week 0 to week 56 Number Analyzed 100 participants 100 participants
-0.022  (0.053) -0.023  (0.051)
Change from week 56 to week 82 Number Analyzed 98 participants 97 participants
0.010  (0.031) 0.003  (0.049)
11.Secondary Outcome
Title Change in hsCRP
Hide Description Change in high sensitivity C reactive protein (hsCRP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the safety analysis set (SAS) which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: mg/L
Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
-0.22  (5.04) -0.56  (4.68)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-0.25  (4.54) -0.14  (3.44)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
1.51  (7.61) 1.00  (4.22)
12.Secondary Outcome
Title Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)
Hide Description Change in total cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of total cholesterol
Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
1.00
(12.8%)
0.98
(13.0%)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
1.00
(14.2%)
1.00
(13.0%)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
1.02
(14.7%)
1.02
(14.9%)
13.Secondary Outcome
Title Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)
Hide Description Change in low density lipoprotein (LDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of LDL-cholesterol
Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
1.00
(19.8%)
1.00
(26.1%)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
0.99
(21.8%)
1.02
(23.6%)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
1.03
(22.5%)
1.04
(20.6%)
14.Secondary Outcome
Title Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)
Hide Description Change in high density lipoprotein (HDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HDL-cholesterol
Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
1.04
(15.3%)
1.01
(20.5%)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
1.04
(17.4%)
1.02
(18.9%)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
0.99
(15.8%)
1.00
(15.2%)
15.Secondary Outcome
Title Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)
Hide Description Change in non-HDL cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of non-HDL cholesterol
Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
0.98
(16.8%)
0.97
(18.0%)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
0.98
(18.4%)
0.99
(16.7%)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
1.03
(19.8%)
1.02
(18.6%)
16.Secondary Outcome
Title Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)
Hide Description Change in very low density lipoprotein (VLDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of VLDL cholesterol
Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
0.91
(36.8%)
0.90
(42.7%)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
0.92
(43.7%)
0.93
(34.6%)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
1.04
(51.0%)
0.97
(34.1%)
17.Secondary Outcome
Title Change in Fasting Lipid: Triglycerides (Ratio to Baseline)
Hide Description Change in triglycerides from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of triglycerides
Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
0.91
(36.9%)
0.91
(42.9%)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
0.92
(43.2%)
0.93
(34.4%)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
1.04
(50.4%)
0.97
(34.0%)
18.Secondary Outcome
Title Change in Fasting Lipid: FFA (Ratio to Baseline)
Hide Description Change in free fatty acids (FFA) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of FFA
Change from week 0 to week 30 Number Analyzed 116 participants 113 participants
0.96
(57.7%)
0.83
(56.4%)
Change from week 0 to week 56 Number Analyzed 105 participants 100 participants
1.00
(48.9%)
0.95
(50.8%)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
0.99
(55.2%)
0.94
(38.0%)
19.Secondary Outcome
Title Change in Systolic and Diastolic Blood Pressure
Hide Description Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP: Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
-2  (9) -1  (10)
SBP: Change from week 0 to week 56 Number Analyzed 102 participants 101 participants
-2  (10) 1  (10)
SBP: Change from week 56 to week 82 Number Analyzed 99 participants 98 participants
2  (9) 1  (10)
DBP: Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
-0  (8) -1  (10)
DBP: Change from week 0 to week 56 Number Analyzed 102 participants 101 participants
1  (9) -1  (9)
DBP: Change from week 56 to week 82 Number Analyzed 99 participants 98 participants
2  (8) 2  (7)
20.Secondary Outcome
Title Change in HbA1c
Hide Description Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c
Change from week 0 to week 30 Number Analyzed 115 participants 116 participants
-0.1  (0.3) -0.0  (0.3)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-0.1  (0.3) -0.0  (0.2)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
0.1  (0.2) 0.1  (0.3)
21.Secondary Outcome
Title Change in FPG
Hide Description Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed treatment for the corresponding treatment period (week 0-30, week 0-56 or week 0-82).
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: mmol/L
Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
-0.2  (0.4) -0.0  (0.5)
Change from week 0 to week 56 Number Analyzed 105 participants 100 participants
-0.1  (0.5) -0.0  (0.6)
Change from week 56 to week 82 Number Analyzed 99 participants 95 participants
0.1  (0.6) 0.1  (0.5)
22.Secondary Outcome
Title Change in Fasting Insulin (Ratio to Baseline)
Hide Description Change in fasting insulin from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of fasting insulin
Change from week 0 to week 30 Number Analyzed 114 participants 112 participants
1.13
(70.9%)
1.14
(53.7%)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
1.06
(69.4%)
1.10
(73.8%)
Change from week 56 to week 82 Number Analyzed 98 participants 97 participants
1.00
(60.9%)
1.08
(55.2%)
23.Secondary Outcome
Title Change in Fasting C-peptide (Ratio to Baseline)
Hide Description Change in fasting C-peptide from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of fasting C-peptide
Change from week 0 to week 30 Number Analyzed 114 participants 112 participants
1.12
(42.6%)
1.04
(35.1%)
Change from week 0 to week 56 Number Analyzed 105 participants 100 participants
0.98
(44.9%)
0.97
(47.4%)
Change from week 56 to week 82 Number Analyzed 98 participants 96 participants
0.92
(43.6%)
0.94
(32.9%)
24.Secondary Outcome
Title Change in Glycaemic Category
Hide Description Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes (T2DM)" at baseline (weeks -2), and weeks 30, 56 and 82 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes (T2DM): FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame Week -2, week 30, week 56 and week 82
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Count of Participants
Unit of Measure: Participants
Week -2 Number Analyzed 125 participants 126 participants
Normoglycaemia
93
  74.4%
93
  73.8%
Pre-diabetes
31
  24.8%
32
  25.4%
Type 2 diabetes
1
   0.8%
1
   0.8%
Week 30 Number Analyzed 116 participants 116 participants
Normoglycaemia
95
  81.9%
86
  74.1%
Pre-diabetes
19
  16.4%
29
  25.0%
Type 2 diabetes
2
   1.7%
1
   0.9%
Week 56 Number Analyzed 105 participants 101 participants
Normoglycaemia
86
  81.9%
75
  74.3%
Pre-diabetes
17
  16.2%
24
  23.8%
Type 2 diabetes
2
   1.9%
2
   2.0%
Week 82 Number Analyzed 100 participants 99 participants
Normoglycaemia
79
  79.0%
65
  65.7%
Pre-diabetes
20
  20.0%
30
  30.3%
Type 2 diabetes
1
   1.0%
4
   4.0%
25.Secondary Outcome
Title Change in HOMA-B (Ratio to Baseline)
Hide Description Change in homeostasis model assessment of beta-cell function (HOMA-B) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5). Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HOMA-B
Change from week 0 to week 30 Number Analyzed 114 participants 110 participants
1.32
(70.8%)
1.17
(59.5%)
Change from week 0 to week 56 Number Analyzed 105 participants 100 participants
1.13
(67.0%)
1.11
(58.0%)
Change from week 56 to week 82 Number Analyzed 98 participants 95 participants
0.92
(65.9%)
1.02
(50.2%)
26.Secondary Outcome
Title Change in HOMA-IR (Ratio to Baseline)
Hide Description Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin [mU/L] x FPG [mmol/L]/ 22.5. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of HOMA-IR
Change from week 0 to week 30 Number Analyzed 114 participants 110 participants
1.08
(75.2%)
1.14
(55.6%)
Change from week 0 to week 56 Number Analyzed 105 participants 100 participants
1.04
(75.3%)
1.09
(80.0%)
Change from week 56 to week 82 Number Analyzed 98 participants 95 participants
1.03
(64.2%)
1.11
(60.5%)
27.Secondary Outcome
Title Change in IWQOL-Kids
Hide Description Change in Impact of Weight on Quality of Life-Kids (IWQOL-Kids) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The IWQOL-Kids is a 27-item measure of weight-related quality of life. There are four domain scores (Physical Comfort, Body Esteem, Social Life and Family Life) and a total score. Scores for all domains and total score range from 0-100, with higher scores representing better health-related quality of life. IWQOL-kids data at week 82 was not collected, thus could not be evaluated. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Body Esteem: Change from week 0 to week 30 Number Analyzed 112 participants 116 participants
10.62  (19.88) 6.73  (26.87)
Body Esteem: Change from week 0 to week 56 Number Analyzed 104 participants 99 participants
13.33  (19.47) 13.24  (22.72)
Body Esteem: Change from week 56 to week 82 Number Analyzed 0 participants 0 participants
Family Relation: Change from week 0 to week 30 Number Analyzed 112 participants 116 participants
2.53  (9.66) -2.19  (17.53)
Family Relation: Change from week 0 to week 56 Number Analyzed 104 participants 99 participants
1.44  (14.31) 0.97  (5.61)
Family Relation: Change from week 56 to week 82 Number Analyzed 0 participants 0 participants
Physical Function: Change from week 0 to week 30 Number Analyzed 112 participants 116 participants
3.94  (15.34) 0.43  (22.02)
Physical Function: Change from week 0 to week 56 Number Analyzed 104 participants 99 participants
6.17  (15.44) 3.32  (16.60)
Physical Function: Change from week 56 to week 82 Number Analyzed 0 participants 0 participants
Social Life: Change from week 0 to week 30 Number Analyzed 112 participants 116 participants
5.32  (10.56) 1.76  (21.98)
Social Life: Change from week 0 to week 56 Number Analyzed 104 participants 99 participants
5.97  (19.48) 6.06  (14.04)
Social Life: Change from week 56 to week 82 Number Analyzed 0 participants 0 participants
Total: Change from week 0 to week 30 Number Analyzed 112 participants 116 participants
6.16  (11.04) 2.24  (19.69)
Total: Change from week 0 to week 56 Number Analyzed 104 participants 99 participants
7.46  (13.70) 6.72  (11.62)
Total: Change from week 56 to week 82 Number Analyzed 0 participants 0 participants
28.Secondary Outcome
Title Change in BMI SDS (%)
Hide Description Relative change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 56. Results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
Time Frame (Week 0, week 30); (Week 0, week 56)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Least Squares Mean (Standard Error)
Unit of Measure: Percentage change
Change from week 0 to week 30 Number Analyzed 119 participants 116 participants
-8.73  (1.05) -1.70  (1.07)
Change from week 0 to week 56 Number Analyzed 113 participants 105 participants
-8.32  (1.68) -0.68  (1.74)
29.Secondary Outcome
Title Change in Nutritional Compliance
Hide Description This outcome measure presents "nutritional compliance results" recorded at baseline (week 0), week 30 and week 56. Nutritional compliance was recorded on a 0 to 10 numeric rating scale, with higher scores representing better compliance. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
Time Frame Week 0, week 30 and week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). "Overall Number of Participants Analyzed" = FAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 0 Number Analyzed 123 participants 126 participants
7.10  (1.74) 7.07  (1.69)
Week 30 Number Analyzed 114 participants 114 participants
6.74  (2.08) 6.51  (1.91)
Week 56 Number Analyzed 100 participants 101 participants
6.87  (1.87) 6.45  (1.84)
30.Secondary Outcome
Title Number of Treatment Emergent Adverse Events
Hide Description A treatment emergent adverse event (TEAE) was defined as an event that occurred in the "on-treatment" period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit).
Time Frame Week 0-56 + 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Number
Unit of Measure: Events
777 627
31.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)
Hide Description A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia episodes were recorded as per international society for pediatric and adolescent diabetes (ISPAD) definition. And the following presented hypoglycaemia episodes were recorded as per American Diabetes Association (ADA) definition: asymptomatic hypoglycaemia, documented symptomatic hypoglycaemia, pseudo-hypoglycaemia and probable symptomatic hypoglycaemia.
Time Frame Week 0-56 + 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Number
Unit of Measure: Episodes
Severe hypoglycaemia 0 0
Asymptomatic hypoglycaemia 12 17
Documented symptomatic hypoglycaemia 31 6
Probable symptomatic hypoglycaemia 1 2
Pseudo-hypoglycaemia 30 3
Unclassifiable 4 0
32.Secondary Outcome
Title Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)
Hide Description Severe hypoglycaemia episodes were recorded as per the ISPAD definition. And the following presented hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG-confirmed: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Time Frame Week 0-56 + 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Number
Unit of Measure: Episodes
Severe hypoglycaemia 0 0
Asymptomatic BG-confirmed hypoglycaemia 1 1
Symptomatic BG-confirmed hypoglycaemia 4 0
Unclassifiable 73 27
33.Secondary Outcome
Title Occurrence of Anti-liraglutide Antibodies
Hide Description This outcome measure is only applicable for the liraglutide 3.0 mg treatment arm. Number of participants who measured with anti-liraglutide binding antibodies at weeks 0, 30, 56, 58, 70 and 82 are presented.
Time Frame Weeks 0, 30, 56, 58, 70 and 82
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125
Measure Type: Count of Participants
Unit of Measure: Participants
Weeks 0 Number Analyzed 125 participants
0
   0.0%
Weeks 30 Number Analyzed 117 participants
6
   5.1%
Weeks 56 Number Analyzed 103 participants
5
   4.9%
Weeks 58 Number Analyzed 113 participants
11
   9.7%
Weeks 70 Number Analyzed 102 participants
6
   5.9%
Weeks 82 Number Analyzed 100 participants
2
   2.0%
34.Secondary Outcome
Title Change in Pulse
Hide Description Change in pulse was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: Beats/minute
Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
4  (12) -1  (12)
Change from week 0 to week 56 Number Analyzed 101 participants 101 participants
4  (11) -1  (12)
Change from week 56 to week 82 Number Analyzed 98 participants 98 participants
-3  (9) 2  (11)
35.Secondary Outcome
Title Change in ECG
Hide Description This outcome measure presents number of subjects with electrocardiogram findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" recorded at baseline (week -14), week 30 and week 56. These findings were categorised by the investigator. Electrocardiogram (ECG) data at week 82 was not collected, thus could not be evaluated. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
Time Frame Week -14, week 30, week 56 and week 82
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Count of Participants
Unit of Measure: Participants
Week -14 Number Analyzed 125 participants 126 participants
Normal
102
  81.6%
100
  79.4%
Abnormal, NCS
23
  18.4%
26
  20.6%
Abnormal, CS
0
   0.0%
0
   0.0%
Week 30 Number Analyzed 117 participants 116 participants
Normal
97
  82.9%
95
  81.9%
Abnormal, NCS
20
  17.1%
21
  18.1%
Abnormal, CS
0
   0.0%
0
   0.0%
Week 56 Number Analyzed 104 participants 103 participants
Normal
83
  79.8%
80
  77.7%
Abnormal, NCS
21
  20.2%
23
  22.3%
Abnormal, CS
0
   0.0%
0
   0.0%
Week 82 Number Analyzed 0 participants 0 participants
Normal
Abnormal, NCS
Abnormal, CS
36.Secondary Outcome
Title Change in Haematology: Haemoglobin
Hide Description Change in haemoglobin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: mmol/L
Change from week 0 to week 30 Number Analyzed 114 participants 115 participants
0.2  (0.5) 0.0  (0.4)
Change from week 0 to week 56 Number Analyzed 103 participants 99 participants
0.3  (0.6) 0.1  (0.6)
Change from week 56 to week 82 Number Analyzed 96 participants 92 participants
-0.1  (0.6) -0.0  (0.4)
37.Secondary Outcome
Title Change in Haematology: Haematocrit
Hide Description Change in haematocrit was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: % of red blood cells
Change from week 0 to week 30 Number Analyzed 114 participants 114 participants
0.7  (2.3) 0.1  (2.4)
Change from week 0 to week 56 Number Analyzed 103 participants 99 participants
1.2  (2.7) 0.4  (2.8)
Change from week 56 to week 82 Number Analyzed 96 participants 92 participants
-0.4  (2.9) -0.4  (1.9)
38.Secondary Outcome
Title Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes
Hide Description Change in haematological parameters, "thrombocytes, leucocytes, eosinophils, neutrophils, basophils, lymphocytes and monocytes" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Thrombocytes: Change from week 0 to week 30 Number Analyzed 113 participants 114 participants
9  (37) 14  (38)
Thrombocytes: Change from week 0 to week 56 Number Analyzed 102 participants 99 participants
7  (46) 7  (39)
Thrombocytes: Change from week 56 to week 82 Number Analyzed 95 participants 92 participants
-2  (31) 3  (37)
Leucocytes: Change from week 0 to week 30 Number Analyzed 114 participants 115 participants
0.1  (1.6) -0.1  (2)
Leucocytes: Change from week 0 to week 56 Number Analyzed 103 participants 99 participants
-0.2  (1.6) -0.4  (1.7)
Leucocytes: Change from week 56 to week 82 Number Analyzed 94 participants 91 participants
0.2  (1.5) 0.0  (2.0)
Eosinophils: Change from week 0 to week 30 Number Analyzed 112 participants 114 participants
0.03  (0.15) 0.04  (0.29)
Eosinophils: Change from week 0 to week 56 Number Analyzed 103 participants 97 participants
0.01  (0.15) 0.00  (0.23)
Eosinophils: Change from week 56 to week 82 Number Analyzed 94 participants 89 participants
-0.01  (0.12) 0.00  (0.15)
Neutrophils: Change from week 0 to week 30 Number Analyzed 112 participants 114 participants
0.18  (1.33) -0.01  (1.71)
Neutrophils: Change from week 0 to week 56 Number Analyzed 103 participants 97 participants
-0.01  (1.49) -0.13  (1.50)
Neutrophils: Change from week 56 to week 82 Number Analyzed 94 participants 89 participants
0.21  (1.35) -0.00  (1.71)
Basophils: Change from week 0 to week 30 Number Analyzed 112 participants 114 participants
0.01  (0.03) 0.01  (0.03)
Basophils: Change from week 0 to week 56 Number Analyzed 103 participants 97 participants
0.01  (0.03) 0.02  (0.03)
Basophils: Change from week 56 to week 82 Number Analyzed 94 participants 89 participants
0.00  (0.03) 0.00  (0.03)
Lymphocytes: Change from week 0 to week 30 Number Analyzed 112 participants 114 participants
-0.18  (0.69) -0.14  (0.62)
Lymphocytes: Change from week 0 to week 56 Number Analyzed 103 participants 97 participants
-0.28  (0.59) -0.27  (0.72)
Lymphocytes: Change from week 56 to week 82 Number Analyzed 94 participants 89 participants
-0.03  (0.48) -0.00  (0.61)
Monocytes: Change from week 0 to week 30 Number Analyzed 112 participants 114 participants
0.04  (0.16) 0.00  (0.18)
Monocytes: Change from week 0 to week 56 Number Analyzed 103 participants 97 participants
0.06  (0.13) 0.01  (0.17)
Monocytes: Change from week 56 to week 82 Number Analyzed 94 participants 89 participants
-0.00  (0.15) 0.04  (0.18)
39.Secondary Outcome
Title Change in Haematology: Erythrocytes
Hide Description Change in erythrocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: 10^12 cells/L
Change from week 0 to week 30 Number Analyzed 114 participants 115 participants
0.0  (0.2) -0.0  (0.3)
Change from week 0 to week 56 Number Analyzed 103 participants 99 participants
-0.0  (0.3) -0.1  (0.3)
Change from week 56 to week 82 Number Analyzed 96 participants 92 participants
-0.1  (0.3) 0.0  (0.2)
40.Secondary Outcome
Title Change in Biochemistry: Creatinine and Bilirubin (Total)
Hide Description Change in creatinine and bilirubin (total) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: umol/L
Creatinine: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
1  (7) 0  (8)
Creatinine: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
2  (7) 4  (9)
Creatinine: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
2  (8) 1  (10)
Bilirubin (total): Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
1  (4) 1  (5)
Bilirubin (total): Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
1  (4) 1  (5)
Bilirubin (total): Change from week 56 to week 82 Number Analyzed 99 participants 96 participants
0  (5) -0  (4)
41.Secondary Outcome
Title Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
Hide Description Change in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: U/L
Creatinine kinase: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
13  (251) 0  (225)
Creatinine kinase: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
32  (228) 0  (111)
Creatinine kinase: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
28  (321) 4  (114)
Amylase: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
4  (12) 3  (16)
Amylase: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
2  (10) -0  (9)
Amylase: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
-1  (8) 1  (11)
Lipase: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
6  (13) 1  (19)
Lipase: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
3  (13) -2  (5)
Lipase: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
-4  (9) -0  (5)
ALT: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
-2  (15) -1  (15)
ALT: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-2  (16) -0  (23)
ALT: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
1  (12) 2  (20)
AST: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
-1  (8) -1  (11)
AST: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-1  (8) -1  (11)
AST: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
1  (12) 1  (11)
ALP: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
-16  (25) -8  (66)
ALP: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-23  (36) -19  (53)
ALP: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
-2  (22) -10  (24)
42.Secondary Outcome
Title Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected
Hide Description Change in biochemistry parameters, "urea (blood urea nitrogen [BUN]), sodium, potassium, calcium total and calcium (Ca) albumin-corrected" was evaluated from baseline (week [Wk] 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: mmol/L
Urea (BUN): Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
-0.06  (1.07) 0.00  (1.14)
Urea (BUN): Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-0.26  (1.01) -0.05  (1.19)
Urea (BUN): Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
0.23  (1.11) 0.00  (1.07)
Sodium: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
0  (2) 0  (2)
Sodium: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
0  (2) 0  (3)
Sodium: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
-1  (3) -1  (3)
Potassium: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
-0.0  (0.4) 0.0  (0.3)
Potassium: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-0.1  (0.4) -0.0  (0.3)
Potassium: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
0.0  (0.3) -0.0  (0.4)
Calcium total: Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
-0.01  (0.09) -0.03  (0.09)
Calcium total: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-0.04  (0.10) -0.04  (0.09)
Calcium total: Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
-0.00  (0.09) -0.01  (0.09)
Ca albumin-corrected:Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
-0.04  (0.09) -0.03  (0.09)
Ca albumin-corrected:Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-0.07  (0.10) -0.07  (0.08)
Ca albumin-corrected: Change from Wk 56 to Wk 82 Number Analyzed 99 participants 97 participants
0.01  (0.07) -0.00  (0.09)
43.Secondary Outcome
Title Change in Biochemistry: Albumin
Hide Description Change in albumin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: g/dL
Change from week 0 to week 30 Number Analyzed 116 participants 116 participants
0.1  (0.2) 0.0  (0.3)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
0.1  (0.3) 0.1  (0.3)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
-0.0  (0.2) -0.0  (0.3)
44.Secondary Outcome
Title Change in Biochemistry: CEA
Hide Description Change in carcinoembryonic antigen (CEA) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: ng/mL
Change from week 0 to week 30 Number Analyzed 116 participants 115 participants
-0.0  (0.3) -0.1  (0.6)
Change from week 0 to week 56 Number Analyzed 104 participants 101 participants
0.0  (0.4) -0.0  (0.6)
Change from week 56 to week 82 Number Analyzed 98 participants 96 participants
0.0  (0.4) 0.0  (0.3)
45.Secondary Outcome
Title Change in Hormone Level: Calcitonin
Hide Description Change in calcitonin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: ng/L
Change from week 0 to week 30 Number Analyzed 116 participants 113 participants
0.1  (0.8) 0.1  (0.7)
Change from week 0 to week 56 Number Analyzed 105 participants 99 participants
0.0  (0.7) -0.0  (0.8)
Change from week 56 to week 82 Number Analyzed 99 participants 94 participants
-0.1  (0.6) 0.2  (1.5)
46.Secondary Outcome
Title Change in Hormone Level: TSH and Prolactin
Hide Description Change in hormone levels, "thyroid stimulating hormone (TSH) and prolactin" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: mIU/L
TSH: Change from week 0 to week 30 Number Analyzed 115 participants 114 participants
-0.35  (1.37) -0.08  (1.17)
TSH: Change from week 0 to week 56 Number Analyzed 104 participants 99 participants
-0.42  (1.36) -0.14  (1.28)
TSH: Change from week 56 to week 82 Number Analyzed 96 participants 97 participants
0.38  (1.91) 0.13  (1.57)
Prolactin: Change from week 0 to week 30 Number Analyzed 115 participants 116 participants
23  (165) -47  (452)
Prolactin: Change from week 0 to week 56 Number Analyzed 104 participants 101 participants
63  (312) -63  (684)
Prolactin: Change from week 56 to week 82 Number Analyzed 98 participants 97 participants
-29  (396) 13  (98)
47.Secondary Outcome
Title Change in Hormone Level: Free T4 and ACTH
Hide Description Change in hormone levels, "thyroxine (T4) and adrenocorticotropic hormone (ACTH)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: pmol/L
T4: Change from week 0 to week 30 Number Analyzed 115 participants 116 participants
0.6  (1.9) 0.8  (2.1)
T4: Change from week 0 to week 56 Number Analyzed 104 participants 101 participants
0.3  (1.8) 0.6  (2.1)
T4: Change from week 56 to week 82 Number Analyzed 98 participants 97 participants
0.0  (1.6) 0.2  (2.3)
ACTH: Change from week 0 to week 30 Number Analyzed 111 participants 113 participants
0.4  (4.4) 0.5  (3.9)
ACTH: Change from week 0 to week 56 Number Analyzed 100 participants 100 participants
0.6  (4.9) 0.6  (3.8)
ACTH: Change from week 56 to week 82 Number Analyzed 98 participants 96 participants
-0.8  (4.7) -0.4  (2.9)
48.Secondary Outcome
Title Change in Hormone Level: IGF-1 and Cortisol
Hide Description Change in hormone levels, "insulin-like growth factor-1 (IGF-1) and cortisol" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: ng/mL
IGF-1: Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
10.61  (89.83) 3.79  (101.12)
IGF-1: Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-4.60  (84.51) 3.69  (111.63)
IGF-1: Change from week 56 to week 82 Number Analyzed 99 participants 96 participants
-14.60  (80.82) -16.35  (65.89)
Cortisol: Change from week 0 to week 30 Number Analyzed 115 participants 116 participants
6.9  (66.9) 8.6  (60.1)
Cortisol: Change from week 0 to week 56 Number Analyzed 104 participants 101 participants
5.1  (65.2) 8.5  (57.9)
Cortisol: Change from week 56 to week 82 Number Analyzed 97 participants 97 participants
0.6  (66.6) 10.4  (61.2)
49.Secondary Outcome
Title Change in Hormone Level: DHEAS
Hide Description Change in dehydroepiandrosterone sulfate (DHEAS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: umol/L
Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
0.94  (1.66) 0.57  (1.78)
Change from week 0 to week 56 Number Analyzed 103 participants 101 participants
0.95  (1.91) 0.89  (2.05)
Change from week 56 to week 82 Number Analyzed 97 participants 97 participants
-0.08  (2.11) -0.05  (1.27)
50.Secondary Outcome
Title Change in Hormone Level: LH and FSH
Hide Description Change in hormone levels, "luteinising hormone (LH) and follicle stimulating hormone (FSH)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: IU/L
LH: Change from week 0 to week 30 Number Analyzed 115 participants 116 participants
0.4  (9.1) 0.7  (7.9)
LH: Change from week 0 to week 56 Number Analyzed 104 participants 101 participants
0.2  (9.1) 0.6  (6.6)
LH: Change from week 56 to week 82 Number Analyzed 98 participants 97 participants
0.4  (8.7) -0.5  (8.0)
FSH: Change from week 0 to week 30 Number Analyzed 113 participants 114 participants
0.2  (2.6) -0.2  (2.7)
FSH: Change from week 0 to week 56 Number Analyzed 104 participants 98 participants
0.6  (4.0) 0.1  (2.5)
FSH: Change from week 56 to week 82 Number Analyzed 96 participants 96 participants
-0.1  (3.6) -0.1  (3.1)
51.Secondary Outcome
Title Change in Hormone Level: Estradiol (Females)
Hide Description Change in estradiol (only for female) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 71 78
Mean (Standard Deviation)
Unit of Measure: pg/mL
Change from week 0 to week 30 Number Analyzed 65 participants 71 participants
-5.0  (81.0) 20.2  (67.6)
Change from week 0 to week 56 Number Analyzed 56 participants 60 participants
11.6  (94.4) 14.1  (63.6)
Change from week 56 to week 82 Number Analyzed 52 participants 58 participants
-2.3  (89.1) -1.7  (65.3)
52.Secondary Outcome
Title Change in Hormone Level: Testosterone (Males)
Hide Description This outcome measure presents "testosterone (only for males) results" for baseline (week 0), week 30, week 56 and week 82. ADVIA Centaur Testosterone (TSTO) assay was used for the evaluation of testosterone hormone. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame Week 0, week 30, week 56 and week 82
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 54 48
Mean (Standard Deviation)
Unit of Measure: nmol/L
Week 0 Number Analyzed 53 participants 48 participants
8.13  (3.45) 8.06  (3.66)
Week 30 Number Analyzed 51 participants 45 participants
10.00  (4.02) 9.33  (5.27)
Week 56 Number Analyzed 39 participants 33 participants
10.55  (4.14) 9.51  (3.31)
Week 82 Number Analyzed 9 participants 5 participants
11.36  (5.27) 6.16  (3.27)
53.Secondary Outcome
Title Change in NTX1
Hide Description Change in type I collagen N-telopeptide (NTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are presented in "nmol bone collagen equivalents (BCE)/L". Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: nmol BCE/L
Change from week 0 to week 30 Number Analyzed 116 participants 114 participants
-2.4  (10.4) -3.2  (12.0)
Change from week 0 to week 56 Number Analyzed 104 participants 101 participants
-3.7  (14.1) -2.9  (15.1)
Change from week 56 to week 82 Number Analyzed 97 participants 97 participants
-2.8  (12.8) -4.6  (10.0)
54.Secondary Outcome
Title Change in CTX1
Hide Description Change in type I collagen C-telopeptide (CTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: pg/mL
Change from week 0 to week 30 Number Analyzed 115 participants 114 participants
-7  (358) -84  (404)
Change from week 0 to week 56 Number Analyzed 104 participants 100 participants
-36  (353) -97  (473)
Change from week 56 to week 82 Number Analyzed 99 participants 97 participants
-107  (359) -162  (318)
55.Secondary Outcome
Title Change in P1NP
Hide Description Change in procollagen 1 N-terminal propeptide (P1NP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: ng/mL
Change from week 0 to week 30 Number Analyzed 115 participants 115 participants
-35  (124) -30  (184)
Change from week 0 to week 56 Number Analyzed 105 participants 101 participants
-55  (151) -63  (192)
Change from week 56 to week 82 Number Analyzed 99 participants 95 participants
-30  (107) -47  (84)
56.Secondary Outcome
Title Change in Alkaline Phosphatase (Bone)
Hide Description Change in alkaline phosphatase (bone specific) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: U/L
Change from week 0 to week 30 Number Analyzed 116 participants 113 participants
-15  (16) -12  (26)
Change from week 0 to week 56 Number Analyzed 105 participants 100 participants
-17  (18) -17  (30)
Change from week 56 to week 82 Number Analyzed 99 participants 96 participants
-1  (11) -4  (12)
57.Secondary Outcome
Title Change in Pubertal Status
Hide Description This outcome measure presents "pubertal status results" which is based on Tanner staging (Tanner stage 2-5), recorded at baseline (week 0), week 30, week 56 and week 82. Results are presented for the following categories: 1) For female: breast development and pubic hair development (by Tanner staging). 2) For male: penis development and pubic hair development (by Tanner staging). Each category shows number of participants in stages 2 to 5, where stage 2 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult". Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0: Breast development (for female) Number Analyzed 71 participants 78 participants
Stage 2
2
   2.8%
1
   1.3%
Stage 3
6
   8.5%
8
  10.3%
Stage 4
23
  32.4%
30
  38.5%
Stage 5
40
  56.3%
39
  50.0%
Week 30: Breast development (for female) Number Analyzed 66 participants 74 participants
Stage 2
1
   1.5%
0
   0.0%
Stage 3
4
   6.1%
6
   8.1%
Stage 4
22
  33.3%
25
  33.8%
Stage 5
39
  59.1%
43
  58.1%
Week 56: Breast development (for female) Number Analyzed 57 participants 63 participants
Stage 2
0
   0.0%
0
   0.0%
Stage 3
2
   3.5%
2
   3.2%
Stage 4
14
  24.6%
20
  31.7%
Stage 5
41
  71.9%
41
  65.1%
Week 82: Breast development (for female) Number Analyzed 53 participants 61 participants
Stage 2
0
   0.0%
0
   0.0%
Stage 3
0
   0.0%
2
   3.3%
Stage 4
7
  13.2%
13
  21.3%
Stage 5
46
  86.8%
46
  75.4%
Week 0: Pubic hair development (for female) Number Analyzed 71 participants 78 participants
Stage 2
2
   2.8%
3
   3.8%
Stage 3
6
   8.5%
5
   6.4%
Stage 4
22
  31.0%
26
  33.3%
Stage 5
41
  57.7%
44
  56.4%
Week 30: Pubic hair development (for female) Number Analyzed 66 participants 74 participants
Stage 2
1
   1.5%
0
   0.0%
Stage 3
4
   6.1%
4
   5.4%
Stage 4
20
  30.3%
25
  33.8%
Stage 5
41
  62.1%
45
  60.8%
Week 56: Pubic hair development (for female) Number Analyzed 57 participants 63 participants
Stage 2
1
   1.8%
0
   0.0%
Stage 3
2
   3.5%
2
   3.2%
Stage 4
13
  22.8%
21
  33.3%
Stage 5
41
  71.9%
40
  63.5%
Week 82: Pubic hair development (for female) Number Analyzed 53 participants 61 participants
Stage 2
0
   0.0%
0
   0.0%
Stage 3
1
   1.9%
2
   3.3%
Stage 4
7
  13.2%
14
  23.0%
Stage 5
45
  84.9%
45
  73.8%
Week 0: penis development (male) Number Analyzed 54 participants 48 participants
Stage 2
4
   7.4%
7
  14.6%
Stage 3
11
  20.4%
8
  16.7%
Stage 4
16
  29.6%
14
  29.2%
Stage 5
23
  42.6%
19
  39.6%
Week 30: penis development (male) Number Analyzed 51 participants 45 participants
Stage 2
1
   2.0%
2
   4.4%
Stage 3
11
  21.6%
7
  15.6%
Stage 4
14
  27.5%
11
  24.4%
Stage 5
25
  49.0%
25
  55.6%
Week 56: penis development (male) Number Analyzed 48 participants 41 participants
Stage 2
1
   2.1%
0
   0.0%
Stage 3
6
  12.5%
6
  14.6%
Stage 4
15
  31.3%
6
  14.6%
Stage 5
26
  54.2%
29
  70.7%
Week 82: penis development (male) Number Analyzed 45 participants 38 participants
Stage 2
0
   0.0%
0
   0.0%
Stage 3
3
   6.7%
3
   7.9%
Stage 4
11
  24.4%
6
  15.8%
Stage 5
31
  68.9%
29
  76.3%
Week 0: Pubic hair development (male) Number Analyzed 54 participants 48 participants
Stage 2
6
  11.1%
9
  18.8%
Stage 3
8
  14.8%
5
  10.4%
Stage 4
19
  35.2%
13
  27.1%
Stage 5
21
  38.9%
21
  43.8%
Week 30: Pubic hair development (male) Number Analyzed 50 participants 45 participants
Stage 2
1
   2.0%
3
   6.7%
Stage 3
10
  20.0%
7
  15.6%
Stage 4
15
  30.0%
9
  20.0%
Stage 5
24
  48.0%
26
  57.8%
Week 56: Pubic hair development (male) Number Analyzed 47 participants 41 participants
Stage 2
1
   2.1%
0
   0.0%
Stage 3
7
  14.9%
6
  14.6%
Stage 4
15
  31.9%
7
  17.1%
Stage 5
24
  51.1%
28
  68.3%
Week 82: Pubic hair development (male) Number Analyzed 43 participants 38 participants
Stage 2
0
   0.0%
0
   0.0%
Stage 3
3
   7.0%
2
   5.3%
Stage 4
10
  23.3%
8
  21.1%
Stage 5
30
  69.8%
28
  73.7%
58.Secondary Outcome
Title Change in Physical Examination
Hide Description This outcome measure presents number of subjects with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0), week 30, week 56 and week 82. These findings were categorised by the investigator. Results include examination of: "general appearance"; "head, ears, eyes, nose, throat, neck"; "respiratory system"; "cardiovascular system (CVS)"; "gastrointestinal (GI) system including mouth"; "musculoskeletal system"; "central nervous system (CNS) and peripheral nervous system (PNS)"; "skin"; "thyroid gland" and "lymph node palpation". Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame Week 0, week 30, week 56 and week 82
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Count of Participants
Unit of Measure: Participants
General Appearance: Week 0 Number Analyzed 125 participants 126 participants
Normal
93
  74.4%
101
  80.2%
Abnormal, NCS
30
  24.0%
23
  18.3%
Abnormal, CS
2
   1.6%
2
   1.6%
General Appearance: Week 30 Number Analyzed 116 participants 116 participants
Normal
94
  81.0%
95
  81.9%
Abnormal, NCS
21
  18.1%
20
  17.2%
Abnormal, CS
1
   0.9%
1
   0.9%
General Appearance: Week 56 Number Analyzed 104 participants 102 participants
Normal
84
  80.8%
85
  83.3%
Abnormal, NCS
18
  17.3%
16
  15.7%
Abnormal, CS
2
   1.9%
1
   1.0%
General Appearance: Week 82 Number Analyzed 99 participants 99 participants
Normal
80
  80.8%
81
  81.8%
Abnormal, NCS
18
  18.2%
17
  17.2%
Abnormal, CS
1
   1.0%
1
   1.0%
Head, ears, eyes, nose, throat, neck: Week 0 Number Analyzed 125 participants 126 participants
Normal
120
  96.0%
116
  92.1%
Abnormal, NCS
5
   4.0%
10
   7.9%
Abnormal, CS
0
   0.0%
0
   0.0%
Head, ears, eyes, nose, throat, neck: Week 30 Number Analyzed 116 participants 116 participants
Normal
114
  98.3%
107
  92.2%
Abnormal, NCS
2
   1.7%
9
   7.8%
Abnormal, CS
0
   0.0%
0
   0.0%
Head, ears, eyes, nose, throat, neck: Week 56 Number Analyzed 104 participants 102 participants
Normal
101
  97.1%
98
  96.1%
Abnormal, NCS
3
   2.9%
4
   3.9%
Abnormal, CS
0
   0.0%
0
   0.0%
Head, ears, eyes, nose, throat, neck: Week 82 Number Analyzed 99 participants 99 participants
Normal
98
  99.0%
94
  94.9%
Abnormal, NCS
1
   1.0%
5
   5.1%
Abnormal, CS
0
   0.0%
0
   0.0%
Respiratory system: Week 0 Number Analyzed 125 participants 126 participants
Normal
125
 100.0%
123
  97.6%
Abnormal, NCS
0
   0.0%
3
   2.4%
Abnormal, CS
0
   0.0%
0
   0.0%
Respiratory system: Week 30 Number Analyzed 116 participants 116 participants
Normal
116
 100.0%
115
  99.1%
Abnormal, NCS
0
   0.0%
1
   0.9%
Abnormal, CS
0
   0.0%
0
   0.0%
Respiratory system: Week 56 Number Analyzed 104 participants 102 participants
Normal
104
 100.0%
101
  99.0%
Abnormal, NCS
0
   0.0%
1
   1.0%
Abnormal, CS
0
   0.0%
0
   0.0%
Respiratory system: Week 82 Number Analyzed 99 participants 99 participants
Normal
99
 100.0%
96
  97.0%
Abnormal, NCS
0
   0.0%
3
   3.0%
Abnormal, CS
0
   0.0%
0
   0.0%
Cardiovascular system: Week 0 Number Analyzed 125 participants 126 participants
Normal
124
  99.2%
125
  99.2%
Abnormal, NCS
1
   0.8%
1
   0.8%
Abnormal, CS
0
   0.0%
0
   0.0%
Cardiovascular system: Week 30 Number Analyzed 116 participants 116 participants
Normal
115
  99.1%
112
  96.6%
Abnormal, NCS
1
   0.9%
4
   3.4%
Abnormal, CS
0
   0.0%
0
   0.0%
Cardiovascular system: Week 56 Number Analyzed 104 participants 102 participants
Normal
102
  98.1%
100
  98.0%
Abnormal, NCS
2
   1.9%
2
   2.0%
Abnormal, CS
0
   0.0%
0
   0.0%
Cardiovascular system: Week 82 Number Analyzed 99 participants 99 participants
Normal
97
  98.0%
98
  99.0%
Abnormal, NCS
2
   2.0%
1
   1.0%
Abnormal, CS
0
   0.0%
0
   0.0%
GI system including mouth: Week 0 Number Analyzed 125 participants 126 participants
Normal
119
  95.2%
119
  94.4%
Abnormal, NCS
5
   4.0%
6
   4.8%
Abnormal, CS
1
   0.8%
1
   0.8%
GI system including mouth: Week 30 Number Analyzed 116 participants 116 participants
Normal
111
  95.7%
109
  94.0%
Abnormal, NCS
5
   4.3%
6
   5.2%
Abnormal, CS
0
   0.0%
1
   0.9%
GI system including mouth: Week 56 Number Analyzed 104 participants 102 participants
Normal
102
  98.1%
98
  96.1%
Abnormal, NCS
2
   1.9%
4
   3.9%
Abnormal, CS
0
   0.0%
0
   0.0%
GI system including mouth: Week 82 Number Analyzed 99 participants 99 participants
Normal
96
  97.0%
94
  94.9%
Abnormal, NCS
1
   1.0%
5
   5.1%
Abnormal, CS
2
   2.0%
0
   0.0%
Musculoskeletal system: Week 0 Number Analyzed 125 participants 126 participants
Normal
121
  96.8%
119
  94.4%
Abnormal, NCS
4
   3.2%
7
   5.6%
Abnormal, CS
0
   0.0%
0
   0.0%
Musculoskeletal system: Week 30 Number Analyzed 116 participants 116 participants
Normal
113
  97.4%
106
  91.4%
Abnormal, NCS
3
   2.6%
10
   8.6%
Abnormal, CS
0
   0.0%
0
   0.0%
Musculoskeletal system: Week 56 Number Analyzed 104 participants 102 participants
Normal
102
  98.1%
97
  95.1%
Abnormal, NCS
1
   1.0%
5
   4.9%
Abnormal, CS
1
   1.0%
0
   0.0%
Musculoskeletal system: Week 82 Number Analyzed 99 participants 99 participants
Normal
97
  98.0%
92
  92.9%
Abnormal, NCS
1
   1.0%
7
   7.1%
Abnormal, CS
1
   1.0%
0
   0.0%
CNS and PNS: Week 0 Number Analyzed 125 participants 126 participants
Normal
124
  99.2%
124
  98.4%
Abnormal, NCS
1
   0.8%
2
   1.6%
Abnormal, CS
0
   0.0%
0
   0.0%
CNS and PNS: Week 30 Number Analyzed 116 participants 116 participants
Normal
115
  99.1%
115
  99.1%
Abnormal, NCS
1
   0.9%
1
   0.9%
Abnormal, CS
0
   0.0%
0
   0.0%
CNS and PNS: Week 56 Number Analyzed 104 participants 102 participants
Normal
104
 100.0%
101
  99.0%
Abnormal, NCS
0
   0.0%
1
   1.0%
Abnormal, CS
0
   0.0%
0
   0.0%
CNS and PNS: Week 82 Number Analyzed 99 participants 99 participants
Normal
99
 100.0%
98
  99.0%
Abnormal, NCS
0
   0.0%
1
   1.0%
Abnormal, CS
0
   0.0%
0
   0.0%
Skin: Week 0 Number Analyzed 125 participants 126 participants
Normal
76
  60.8%
58
  46.0%
Abnormal, NCS
47
  37.6%
64
  50.8%
Abnormal, CS
2
   1.6%
4
   3.2%
Skin: Week 30 Number Analyzed 116 participants 116 participants
Normal
71
  61.2%
56
  48.3%
Abnormal, NCS
44
  37.9%
56
  48.3%
Abnormal, CS
1
   0.9%
4
   3.4%
Skin: Week 56 Number Analyzed 104 participants 102 participants
Normal
65
  62.5%
48
  47.1%
Abnormal, NCS
35
  33.7%
53
  52.0%
Abnormal, CS
4
   3.8%
1
   1.0%
Skin: Week 82 Number Analyzed 99 participants 99 participants
Normal
57
  57.6%
50
  50.5%
Abnormal, NCS
40
  40.4%
48
  48.5%
Abnormal, CS
2
   2.0%
1
   1.0%
Thyroid gland: Week 0 Number Analyzed 125 participants 126 participants
Normal
124
  99.2%
124
  98.4%
Abnormal, NCS
1
   0.8%
2
   1.6%
Abnormal, CS
0
   0.0%
0
   0.0%
Thyroid gland: Week 30 Number Analyzed 116 participants 116 participants
Normal
115
  99.1%
114
  98.3%
Abnormal, NCS
1
   0.9%
2
   1.7%
Abnormal, CS
0
   0.0%
0
   0.0%
Thyroid gland: Week 56 Number Analyzed 104 participants 102 participants
Normal
103
  99.0%
101
  99.0%
Abnormal, NCS
1
   1.0%
1
   1.0%
Abnormal, CS
0
   0.0%
0
   0.0%
Thyroid gland: Week 82 Number Analyzed 99 participants 99 participants
Normal
97
  98.0%
98
  99.0%
Abnormal, NCS
2
   2.0%
1
   1.0%
Abnormal, CS
0
   0.0%
0
   0.0%
Lymph node palpation: Week 0 Number Analyzed 125 participants 126 participants
Normal
124
  99.2%
125
  99.2%
Abnormal, NCS
1
   0.8%
1
   0.8%
Abnormal, CS
0
   0.0%
0
   0.0%
Lymph node palpation: Week 30 Number Analyzed 116 participants 116 participants
Normal
115
  99.1%
116
 100.0%
Abnormal, NCS
1
   0.9%
0
   0.0%
Abnormal, CS
0
   0.0%
0
   0.0%
Lymph node palpation: Week 56 Number Analyzed 104 participants 102 participants
Normal
103
  99.0%
102
 100.0%
Abnormal, NCS
1
   1.0%
0
   0.0%
Abnormal, CS
0
   0.0%
0
   0.0%
Lymph node palpation: Week 82 Number Analyzed 99 participants 99 participants
Normal
98
  99.0%
98
  99.0%
Abnormal, NCS
1
   1.0%
1
   1.0%
Abnormal, CS
0
   0.0%
0
   0.0%
59.Secondary Outcome
Title Change in Height SDS
Hide Description Change in height standard deviation score (SDS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Mean (Standard Deviation)
Unit of Measure: SDS
Change from week 0 to week 30 Number Analyzed 119 participants 117 participants
0.11  (0.17) 0.13  (0.18)
Change from week 0 to week 56 Number Analyzed 115 participants 105 participants
0.20  (0.27) 0.24  (0.30)
Change from week 56 to week 82 Number Analyzed 99 participants 98 participants
0.07  (0.16) 0.06  (0.12)
60.Secondary Outcome
Title Change in C-SSRS
Hide Description This outcome measure presents number of subjects with "suicidal ideation or suicidal behaviour on the Columbia Suicidality Severity Rating Scale (C-SSRS)" assessed at baseline (week 0), week 30, week 56 and week 82. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
Time Frame (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Hide Outcome Measure Data
Hide Analysis Population Description
Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = SAS. "Number Analyzed" = number of participants with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Subjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Overall Number of Participants Analyzed 125 126
Measure Type: Count of Participants
Unit of Measure: Participants
Wk 0: Suicidal ideation Number Analyzed 122 participants 126 participants
2
   1.6%
2
   1.6%
Wk 0: Suicidal behaviour Number Analyzed 122 participants 126 participants
0
   0.0%
1
   0.8%
Wk0: Self-injurious behaviour, no suicidal intent Number Analyzed 122 participants 126 participants
0
   0.0%
1
   0.8%
Wk 30: Suicidal ideation Number Analyzed 114 participants 116 participants
0
   0.0%
0
   0.0%
Wk 30: Suicidal behaviour Number Analyzed 114 participants 116 participants
0
   0.0%
0
   0.0%
Wk30: Self-injurious behaviour, no suicidal intent Number Analyzed 114 participants 116 participants
0
   0.0%