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Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting (SCALE™ IBT)

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: NCT02963935
Recruitment Status : Completed
First Posted : November 15, 2016
Results First Posted : July 30, 2019
Last Update Posted : March 11, 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
Behavioral: CMS Intensive Behavior Therapy
Enrollment 282
Recruitment Details The trial was conducted at 17 sites in the United States.
Pre-assignment Details All the subjects received Intensive Behaviour Therapy (IBT) for obesity in a primary care setting according to Centers for Medicare & Medicaid Services (CMS) visit schedule during the trial.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Period Title: Overall Study
Started 142 140
Completed [1] 114 103
Not Completed 28 37
Reason Not Completed
Adverse Event             12             6
Protocol Violation             2             1
Lack of Efficacy             0             2
Lost to Follow-up             1             6
Unclassified             13             22
[1]
Completed without discontinuation of trial product
Arm/Group Title Liraglutide 3.0 mg Placebo Total
Hide Arm/Group Description Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial. Total of all reporting groups
Overall Number of Baseline Participants 142 140 282
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 142 participants 140 participants 282 participants
45.4  (11.6) 49  (11.2) 47.2  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 140 participants 282 participants
Female
119
  83.8%
116
  82.9%
235
  83.3%
Male
23
  16.2%
24
  17.1%
47
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 140 participants 282 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   1.4%
3
   2.1%
5
   1.8%
Native Hawaiian or Other Pacific Islander
1
   0.7%
0
   0.0%
1
   0.4%
Black or African American
27
  19.0%
22
  15.7%
49
  17.4%
White
112
  78.9%
115
  82.1%
227
  80.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 142 participants 140 participants 282 participants
108.5  (22.1) 106.7  (22.0) 107.6  (22.0)
1.Primary Outcome
Title Change in Body Weight (%)
Hide Description

Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which subjects are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).

The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented.

Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: percent change
In-trial observation period Number Analyzed 141 participants 130 participants
-7.4  (7.9) -4.0  (7.4)
On-drug observation period Number Analyzed 114 participants 103 participants
-9.1  (7.4) -4.8  (7.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Treatrment policy estimand. The hypothesis and the alternative are: H: μliraglutide ≥ μplacebo against the alternative HA: μliraglutide < μplacebo. μliraglutide and μplacebo denote the true mean of % weight change for liraglutide 3.0 mg and placebo group, respectively. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.
Type of Statistical Test Superiority
Comments The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised subjects regardless of premature discontinuation of trial product.
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments Missing observations were imputed from the placebo arm based on a jump to reference (x100) multiple imputation approach.
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -3.45
Confidence Interval (2-Sided) 95%
-5.31 to -1.59
Estimation Comments Liraglutide 3.0 mg - placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Hypothetical estimand. Analysis of on-drug data before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit.
Type of Statistical Test Other
Comments The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised subjects assuming that all subjects remained on trial product (on-treatment principle)
Statistical Test of Hypothesis P-Value 0.0000
Comments [Not Specified]
Method Mixed models repeated measurement (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -4.59
Confidence Interval (2-Sided) 95%
-6.54 to -2.64
Estimation Comments Liraglutide 3.0 mg - placebo
2.Primary Outcome
Title Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56
Hide Description The estimated mean percentage of subjects losing at least 5% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: percentage of participants
In-trial observation period Number Analyzed 141 participants 130 participants
61.47 38.82
On-drug observation period Number Analyzed 142 participants 140 participants
64.08 38.57
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.51
Confidence Interval (2-Sided) 95%
1.53 to 4.14
Estimation Comments Liraglutide 3.0 mg/Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments [Not Specified]
Method Mixed models repeated measurement (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.84
Confidence Interval (2-Sided) 95%
1.75 to 4.61
Estimation Comments Liraglutide 3.0 mg/placebo
3.Secondary Outcome
Title Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56
Hide Description The estimated mean percentage of subjects losing more than 10% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: percentage of participants
In-trial observation period Number Analyzed 141 participants 130 participants
30.45 19.75
On-drug observation period Number Analyzed 142 participants 140 participants
33.80 19.29
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x10000) imputation approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0469
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.78
Confidence Interval (2-Sided) 95%
1.01 to 3.14
Estimation Comments Liraglutide 3.0 mg/Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method Mixed models repeated measurement (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.14
Confidence Interval (2-Sided) 95%
1.24 to 3.69
Estimation Comments Liraglutide 3.0 mg/placebo
4.Secondary Outcome
Title Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56
Hide Description The estimated mean percentage of subjects losing more than 15% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: percentage of participants
In-trial observation period Number Analyzed 141 participants 130 participants
18.11 8.92
On-drug observation period Number Analyzed 142 participants 140 participants
20.42 8.57
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0311
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.26
Confidence Interval (2-Sided) 95%
1.08 to 4.74
Estimation Comments Liraglutide 3.0 mg/Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0060
Comments [Not Specified]
Method Mixed models repeated measurement (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.74
Confidence Interval (2-Sided) 95%
1.33 to 5.62
Estimation Comments Liraglutide 3.0 mg/placebo
5.Secondary Outcome
Title Proportion of Subjects Losing 4% or More of Baseline Body Weight
Hide Description The estimated mean percentage of subjects losing 4% or more of baseline body weight at week 16 is presented. The endpoint was evaluated for treatment policy estimand (in-trial data).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: percentage of participants
78.73 52.70
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments

Treatment policy estimand. Week 16 responders were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.

Missing values are considered as non-responders.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.32
Confidence Interval (2-Sided) 95%
1.93 to 5.72
Estimation Comments Liraglutide 3.0 mg/placebo
6.Secondary Outcome
Title Change in Waist Circumference (cm)
Hide Description Observed mean change from baseline in waist circumference. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: cm
In-trial observation period Number Analyzed 141 participants 127 participants
-9.27  (9.22) -6.91  (8.22)
On-drug observation period Number Analyzed 114 participants 103 participants
-10.46  (9.22) -7.24  (8.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter treatment difference
Estimated Value -2.72
Confidence Interval (2-Sided) 95%
-4.68 to -0.77
Estimation Comments Liraglutide 3.0 mg - placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Mixed model repeated measurements (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value -3.45
Confidence Interval (2-Sided) 95%
-5.62 to -1.28
Estimation Comments Liraglutide 3.0 mg - placebo
7.Secondary Outcome
Title Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
Hide Description

SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).

SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical functioning score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.

Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
In-trial observation period Number Analyzed 138 participants 121 participants
3.55  (6.98) 4.21  (6.85)
On-drug observation period Number Analyzed 114 participants 103 participants
4.03  (6.49) 4.77  (6.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8137
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-1.19 to 1.52
Estimation Comments Liraglutide 3.0 mg - placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8053
Comments [Not Specified]
Method Mixed model repeated measurements (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-1.12 to 1.43
Estimation Comments Liraglutide 3.0 mg- placebo
8.Secondary Outcome
Title Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score
Hide Description

Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trials Version (IWQoL-Lite for CT ) score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life.

The endpoint was evaluated based on in-trial data and on-drug data.

Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
In-trial observation period Number Analyzed 138 participants 121 participants
13.5  (21.4) 15.5  (23.0)
On-drug observation period Number Analyzed 114 participants 103 participants
15.2  (21.4) 17.5  (21.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.
Type of Statistical Test Superiority
Comments Superiority was not tested as part of confirmatory testing strategy.
Statistical Test of Hypothesis P-Value 0.6916
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
-3.41 to 5.14
Estimation Comments Liraglutide 3.0 mg - placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5572
Comments [Not Specified]
Method Mixed models repeated measurements (MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter treatment difference
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
-2.95 to 5.45
Estimation Comments Liraglutide 3.0 mg - placebo
9.Secondary Outcome
Title Change in Six Minutes Walking Distance Test (6MWT)
Hide Description Observed mean change from baseline in 6 minutes walking distance test. The 6MWT is a common test of functional exercise capacity that assesses the distance a subject can walk in 6 minutes. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: meter
In-trial observation period Number Analyzed 135 participants 116 participants
47  (59) 49  (69)
On-drug observation period Number Analyzed 112 participants 101 participants
53  (61) 51  (69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.
Type of Statistical Test Superiority
Comments Superiority was not tested as part of confirmatory testing strategy.
Statistical Test of Hypothesis P-Value 0.6986
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 3.12
Confidence Interval (2-Sided) 95%
-12.68 to 18.92
Estimation Comments Liraglutide 3.0 mg - placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3700
Comments [Not Specified]
Method Mixed model repeated measurements (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment difference
Estimated Value 7.66
Confidence Interval (2-Sided) 95%
-9.15 to 24.48
Estimation Comments Liraglutide 3.0 mg - placebo
10.Secondary Outcome
Title Change From Baseline in HbA1c (%)
Hide Description Observed mean change from baseline to week 56 in glycosylated haemoglobin (HbA1c). Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: percentage
-0.2  (0.3) -0.1  (0.2)
11.Secondary Outcome
Title Change From Baseline in FPG (mg/dL)
Hide Description Observed mean change from baseline (week 0) in fasting plasma glucose (FPG). Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mg/dL
-4.04  (9.59) -0.28  (11.46)
12.Secondary Outcome
Title Change From Baseline sBP (mmHg)
Hide Description Observed mean change in systolic blood pressure from baseline to week 56.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmHg
-2  (14) -1  (13)
13.Secondary Outcome
Title Change From Baseline dBP (mmHg)
Hide Description Observed mean change from baseline (week 0) to week 56 in diastolic blood pressure (dBP). Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmHg
-1  (11) -1  (10)
14.Secondary Outcome
Title Change From Baseline in Lipids -Total Cholesterol
Hide Description Observed mean change from baseline (week 0) to week 56 in total cholesterol (TC). Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.01  (0.59) 0.00  (0.77)
15.Secondary Outcome
Title Change From Baseline in Lipids - LDL Cholesterol
Hide Description Observed mean change from baseline in low density cholesterol (LDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.01  (0.52) -0.01  (0.64)
16.Secondary Outcome
Title Change From Baseline in Lipids - HDL Cholesterol
Hide Description Observed mean change from baseline in high density (HDL) cholesterol from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.06  (0.19) 0.02  (0.22)
17.Secondary Outcome
Title Change From Baseline in Lipids - VLDL Cholesterol
Hide Description Observed mean change from baseline in very low density cholesterol (VLDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.06  (0.31) -0.01  (0.26)
18.Secondary Outcome
Title Change From Baseline in Lipids - TG
Hide Description Observed mean change from baseline in triglyceride (TG) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.19  (1.04) -0.01  (0.58)
19.Secondary Outcome
Title Change From Baseline in Lipids - FFA
Hide Description Observed mean change from baseline in free fatty acids (FFA) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.07  (0.28) -0.06  (0.31)
20.Secondary Outcome
Title Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)
Hide Description

SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).

SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Results are evaluated based on in-trial data.

Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Bodily Pain Number Analyzed 138 participants 121 participants
0.67  (7.61) 1.21  (8.88)
General Health Perception Number Analyzed 138 participants 121 participants
1.89  (6.31) 1.08  (6.62)
Mental Health Number Analyzed 138 participants 121 participants
-0.93  (7.80) -0.68  (6.89)
Role Lim Emotion Prob Number Analyzed 138 participants 121 participants
-1.27  (7.72) -2.21  (8.59)
Role Lim. Phy Health Number Analyzed 138 participants 121 participants
2.01  (6.55) 2.11  (7.68)
Social Functioning Number Analyzed 138 participants 121 participants
1.22  (8.69) -0.45  (9.61)
Vitality Number Analyzed 138 participants 121 participants
2.64  (8.99) 2.43  (7.78)
21.Secondary Outcome
Title Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))
Hide Description Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain physical component summary (PCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical component summary (PCS) score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.41  (6.65) 3.83  (7.22)
22.Secondary Outcome
Title Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)
Hide Description Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain mental component summary (MCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 mental component summary is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.22  (8.74) -2.20  (8.11)
23.Secondary Outcome
Title Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score
Hide Description Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) domain pain and discomfort. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: scores on a scale
10.1  (21.2) 8.6  (23.1)
24.Secondary Outcome
Title Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score
Hide Description Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) psychosocial domain. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: score
13.5  (20.3) 12.4  (21.8)
25.Secondary Outcome
Title Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score
Hide Description Observed mean change from baseline (week 0) to week 56 in IWQoL-Lite for CT total score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: scores on a scale
13.2  (18.5) 12.8  (20.7)
26.Secondary Outcome
Title Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score
Hide Description

Observed mean change from baseline (week 0) to week 56 in WRSS measure, total score. The WRSS measures the presence and bothersome associated with weight-related symptoms.

The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint "Weight related sign and symptom (WRSS) measure, total score" couldn't be analysed.

Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: Score on a scale
NA [1]   (NA) NA [1]   (NA)
[1]
The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint "Weight related sign and symptom (WRSS) measure, total score" couldn't be analysed.
27.Secondary Outcome
Title Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score
Hide Description Percentage of subjects who achieved ≥ 4.3 T-score points increase from baseline in SF-36 physical functioning score at week 56 is presented. Results based on FAS in-trial data is presented.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: percentage of participants
38.7 37.9
28.Secondary Outcome
Title Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score
Hide Description Percentage of subjects who achieved ≥ 3.8 T-score points increase from baseline in SF-36 physical component score at week 56 is presented. Results based on FAS in-trial data is presented.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: Percentage of participants
43.7 41.4
29.Secondary Outcome
Title Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score
Hide Description Percentage of subjects who achieved ≥ 4.6 T-score points increase from baseline in SF-36 mental component score at week 56 is presented. Results based on FAS in-trial data is presented.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: Percentage of participants
20.4 9.3
30.Secondary Outcome
Title Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score
Hide Description Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score' was defined as '≥ 20 responder definition value for IWQoL-Lite for CT physical function domain (5-items) score. Percentage of subjects considered IWQoL-Lite for CT physical function domain score responders (increase of ≥20 points) at week 56 is presented. Results based on FAS in-trial data is presented.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: Percentage of participants
37.3 34.3
31.Secondary Outcome
Title Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product
Hide Description Adherence to trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to trial product is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: weeks
49.5  (14.0) 46.8  (16.1)
32.Secondary Outcome
Title Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet
Hide Description Adherence to caloric diet is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: weeks
38.4  (16.0) 36.1  (17.3)
33.Secondary Outcome
Title Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity
Hide Description Adherence to physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to physical activity is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: weeks
29.0  (17.1) 30.0  (17.2)
34.Secondary Outcome
Title Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity
Hide Description Adherence to caloric diet and physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet and physical activity is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: weeks
24.0  (16.0) 24.5  (15.7)
35.Secondary Outcome
Title Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product
Hide Description Adherence to caloric diet, physical activity and trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet, physical activity and trial product is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomised subjects. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: weeks
22.9  (16.1) 24.0  (15.9)
36.Secondary Outcome
Title AEs From Randomisation Until and Including the Follow-up Period
Hide Description Number of adverse events from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on SAS on-drug data is presented.
Time Frame Week 0 to week 56+30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: events
867 601
37.Secondary Outcome
Title Change in Physical Examination
Hide Description Observed change from baseline to week 56 in physical examination are categorised under parameters namely abdomen, gastrointestinal system, cardiovascular system, central and peripheral nervous system, general appearence, head, ears, eyes, nose, throat and neck, lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. The percentage of subjects assessed as normal, abnormal not clinically significant and abnormal clinically significant at baseline and week 56 is presented.
Time Frame Week 1, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: participants
Abdomen (week -1) Normal Number Analyzed 142 participants 140 participants
108 121
Abdomen (week -1) Abnormal, NCS Number Analyzed 142 participants 140 participants
34 19
Abdomen (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
0 0
Abdomen (week 56) Normal Number Analyzed 139 participants 122 participants
114 108
Abdomen (week 56) Abnormal, NCS Number Analyzed 139 participants 122 participants
25 12
Abdomen (week 56) Abnormal, CS Number Analyzed 139 participants 122 participants
0 2
Gastrointestinal System (week -1) Normal Number Analyzed 142 participants 140 participants
130 129
Gastrointestinal System (week -1) Abnormal NCS Number Analyzed 142 participants 140 participants
12 11
Gastrointestinal System (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
0 0
Gastrointestinal System (week 56) Normal Number Analyzed 139 participants 122 participants
132 116
Gastrointestinal System (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
7 6
Gastrointestinal System (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
0 0
Cardiovascular System (week-1) Normal Number Analyzed 142 participants 140 participants
136 127
Cardiovascular System (week-1) Abnormal NCS Number Analyzed 142 participants 140 participants
6 13
Cardiovascular System (week-1) Abnormal CS Number Analyzed 142 participants 140 participants
0 0
Cardiovascular System (week 56) Normal Number Analyzed 139 participants 122 participants
138 116
Cardiovascular System (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
1 5
Cardiovascular System (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
0 1
Nervous System (week -1) Normal Number Analyzed 142 participants 140 participants
135 127
Nervous System (week -1) Abnormal NCS Number Analyzed 142 participants 140 participants
5 6
Nervous System (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
2 7
Nervous System (week 56) Normal Number Analyzed 139 participants 122 participants
132 112
Nervous System (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
6 9
Nervous System (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
1 1
General Appearance (week -1) Normal Number Analyzed 142 participants 140 participants
118 123
General Appearance (week -1) Abnormal NCS Number Analyzed 142 participants 140 participants
24 17
General Appearance (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
0 0
General Appearance (week 56) Normal Number Analyzed 139 participants 122 participants
122 112
General Appearance (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
17 10
General Appearance (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
0 0
Head, ENTand Neck (week -1) Normal Number Analyzed 142 participants 140 participants
129 128
Head, ENTand Neck (week -1) Abnormal NCS Number Analyzed 142 participants 140 participants
13 12
Head, ENTand Neck (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
0 0
Head, ENTand Neck (week 56) Normal Number Analyzed 139 participants 122 participants
126 115
Head, ENTand Neck (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
13 7
Head, ENTand Neck (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
0 0
Lymph Node Palpation (week -1) Normal Number Analyzed 142 participants 140 participants
142 140
Lymph Node Palpation (week -1) Abnormal NCS Number Analyzed 142 participants 140 participants
0 0
Lymph Node Palpation (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
0 0
Lymph Node Palpation (week 56) Normal Number Analyzed 139 participants 122 participants
139 121
Lymph Node Palpation (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
0 0
Lymph Node Palpation (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
0 1
Musculoskeletal System (week -1) Normal Number Analyzed 142 participants 140 participants
131 128
Musculoskeletal System (week -1) Abnormal NCS Number Analyzed 142 participants 140 participants
11 12
Musculoskeletal System (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
0 0
Musculoskeletal System (week 56) Normal Number Analyzed 139 participants 122 participants
130 112
Musculoskeletal System (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
9 9
Musculoskeletal System (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
0 1
Respiratory System (week -1) Normal Number Analyzed 142 participants 140 participants
140 138
Respiratory System (week -1) Abnormal NCS Number Analyzed 142 participants 140 participants
2 2
Respiratory System (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
0 0
Respiratory System (week 56) Normal Number Analyzed 139 participants 122 participants
138 120
Respiratory System (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
1 2
Respiratory System (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
0 0
Skin (week -1) Normal Number Analyzed 142 participants 140 participants
116 114
Skin (week -1) Abnormal NCS Number Analyzed 142 participants 140 participants
26 24
Skin (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
1 0
Skin (week 56) Normal Number Analyzed 139 participants 122 participants
117 98
Skin (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
21 24
Skin (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
1 0
Thyroid Gland (week -1) Normal Number Analyzed 142 participants 140 participants
138 138
Thyroid Gland (week -1) Abnormal NCS Number Analyzed 142 participants 140 participants
4 2
Thyroid Gland (week -1) Abnormal CS Number Analyzed 142 participants 140 participants
0 0
Thyroid Gland (week 56) Normal Number Analyzed 139 participants 122 participants
136 120
Thyroid Gland (week 56) Abnormal NCS Number Analyzed 139 participants 122 participants
3 2
Thyroid Gland (week 56) Abnormal CS Number Analyzed 139 participants 122 participants
0 0
38.Secondary Outcome
Title Change in Resting Pulse
Hide Description Observed mean change in pulse rate measured at resting position is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: beats/min
2  (10) 1  (10)
39.Secondary Outcome
Title Change in ECG
Hide Description The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of subjects in each ECG category at baseline and week 56 are presented.
Time Frame Week -1, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Measure Type: Number
Unit of Measure: participants
Normal (week -1) Number Analyzed 142 participants 140 participants
100 91
Abnormal NCS (week -1) Number Analyzed 142 participants 140 participants
41 49
Abnormal CS (week -1) Number Analyzed 142 participants 140 participants
1 0
Normal (week 56) Number Analyzed 138 participants 124 participants
102 81
Abnormal NCS (week 56) Number Analyzed 138 participants 124 participants
36 42
Abnormal CS (week 56) Number Analyzed 138 participants 124 participants
0 1
40.Secondary Outcome
Title Change in Laboratory Measurements: Haematology (Haemoglobin Blood)
Hide Description Observed mean change from baseline in haematological parameter blood haemoglobin.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.2  (0.5) -0.1  (0.6)
41.Secondary Outcome
Title Change in Laboratory Measurements: Haematology (Haematocrit Blood)
Hide Description Observed mean change from baseline in haematological parameter blood haematocrit. Haematocrit is presented as the percentage of red blood cells in total blood. Results based on SAS on-drug data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: percentage of red blood cells
-1.5  (2.3) -0.9  (2.6)
42.Secondary Outcome
Title Change in Laboratory Measurements: Haematology (Erythrocytes)
Hide Description Observed mean change from baseline in haematological parameter - erythrocytes.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: 10^12 cells/L
-0.11  (0.25) -0.08  (0.25)
43.Secondary Outcome
Title Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)
Hide Description Observed mean change from baseline in haematological parameters - thrombocytss and leukocytes.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/L
Thrombocytes Number Analyzed 109 participants 101 participants
4  (30) 0  (36)
Leukocytes Number Analyzed 110 participants 101 participants
-0.14  (1.53) -0.11  (1.20)
44.Secondary Outcome
Title Change in Laboratory Measurements: Biochemistry (Albumin)
Hide Description Observed mean change from baseline in biochemical parameter - albumin. Results based on SAS on-drug data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: g/L
-0.1  (0.2) -0.1  (0.2)
45.Secondary Outcome
Title Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)
Hide Description Observed mean change from baseline in biochemical parameters - alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase. Results based on SAS on-drug data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: U/L
Alkaline Phosphatase Number Analyzed 111 participants 103 participants
-2  (12) -1  (13)
Alanine Aminotransferase Number Analyzed 111 participants 103 participants
-5  (14) -4  (16)
Amylase Number Analyzed 111 participants 103 participants
4  (10) 1  (13)
Aspartate aminotransferase Number Analyzed 110 participants 103 participants
-3  (10) -2  (12)
Lipase Number Analyzed 111 participants 103 participants
7  (18) 2  (22)
46.Secondary Outcome
Title Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)
Hide Description Observed mean change from baseline in biochemical parameters - bilirubin and creatinine. Results based on SAS on-drug data is presented.
Time Frame Week 0, week 56
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Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
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Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: umol/L
Bilirubin Number Analyzed 111 participants 103 participants
1.1  (3.2) 1.0  (3.2)
Creatinine Number Analyzed 111 participants 103 participants
-1.8  (7.9) -1.4  (6.1)
47.Secondary Outcome
Title Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)
Hide Description Observed mean change from baseline in biochemical parameters - total calcium, pottassium, sodium and urea. Results based on SAS on-drug data is presented.
Time Frame Week 0, week 56
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Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mmol/L
Total Calcium Number Analyzed 111 participants 103 participants
0.01  (0.10) 0.01  (0.09)
Potassium Number Analyzed 111 participants 103 participants
-0.0  (0.5) -0.0  (0.4)
Sodium Number Analyzed 111 participants 103 participants
-0.0  (2) -0  (2)
Urea Number Analyzed 111 participants 103 participants
0.0  (1.2) 0.2  (1.2)
48.Secondary Outcome
Title Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)
Hide Description Observed mean change from baseline in biochemical parameters - high sensitive c-reactive protein and uric acid. Results based on SAS on-drug data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mg/dL
High sensitive c-reactive protein Number Analyzed 111 participants 103 participants
-2.51  (4.67) -0.85  (8.96)
Uric acid Number Analyzed 111 participants 103 participants
-0.6  (0.9) -0.3  (0.9)
49.Secondary Outcome
Title Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)
Hide Description Observed mean change from baseline in biochemical parameters - estimated glomerular filtration rate. Serum GFR is estimated using MDRD formula . Results based on SAS on-drug data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
2  (11) 2  (9)
50.Secondary Outcome
Title Change in Laboratory Measurements: Biochemistry (Calcitonin)
Hide Description Observed mean change from baseline in biochemical parameter - calcitonin. Results based on SAS on-drug data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: ng/L
0.2  (0.8) 0.1  (0.8)
51.Secondary Outcome
Title Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)
Hide Description Observed mean change from baseline in biochemical parameters - thyroid stimulating hormone. Results based on SAS on-drug data is presented.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. "Number analysed"=subjects with available data.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.
Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
Overall Number of Participants Analyzed 142 140
Mean (Standard Deviation)
Unit of Measure: mIU/L
-0.2313  (1.0366) 0.2685  (3.6814)
Time Frame From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days.
Adverse Event Reporting Description

Evaluation of safety was based on safety analysis set (SAS) which comprised of all randomised subjects who received at least one dose of trial product.

AEs with onset during the on-drug observation period (the period when subjects were exposed to trial product) were considered treatment-emergent.

 
Arm/Group Title Lira 3.0 mg Placebo
Hide Arm/Group Description Subjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial. Subjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.
All-Cause Mortality
Lira 3.0 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/142 (0.00%)      0/140 (0.00%)    
Hide Serious Adverse Events
Lira 3.0 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/142 (4.23%)      2/140 (1.43%)    
Gastrointestinal disorders     
Colitis  1  1/142 (0.70%)  1 0/140 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute  1  1/142 (0.70%)  1 0/140 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  0/142 (0.00%)  0 1/140 (0.71%)  1
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/142 (0.70%)  2 0/140 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Papillary thyroid cancer  1  1/142 (0.70%)  1 0/140 (0.00%)  0
Nervous system disorders     
Headache  1  1/142 (0.70%)  1 0/140 (0.00%)  0
Hydrocephalus  1  0/142 (0.00%)  0 1/140 (0.71%)  1
Reproductive system and breast disorders     
Ovarian cyst  1  1/142 (0.70%)  1 0/140 (0.00%)  0
1
Term from vocabulary, MedDRA 21
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lira 3.0 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   124/142 (87.32%)      101/140 (72.14%)    
Gastrointestinal disorders     
Abdominal discomfort  1  8/142 (5.63%)  9 4/140 (2.86%)  4
Constipation  1  43/142 (30.28%)  57 26/140 (18.57%)  34
Diarrhoea  1  31/142 (21.83%)  47 23/140 (16.43%)  26
Dyspepsia  1  8/142 (5.63%)  13 3/140 (2.14%)  3
Nausea  1  68/142 (47.89%)  102 25/140 (17.86%)  33
Vomiting  1  33/142 (23.24%)  47 7/140 (5.00%)  7
General disorders     
Fatigue  1  13/142 (9.15%)  15 5/140 (3.57%)  5
Infections and infestations     
Gastroenteritis viral  1  3/142 (2.11%)  5 9/140 (6.43%)  9
Influenza  1  5/142 (3.52%)  5 13/140 (9.29%)  13
Nasopharyngitis  1  13/142 (9.15%)  17 9/140 (6.43%)  13
Sinusitis  1  9/142 (6.34%)  10 18/140 (12.86%)  20
Upper respiratory tract infection  1  32/142 (22.54%)  38 15/140 (10.71%)  17
Urinary tract infection  1  8/142 (5.63%)  15 3/140 (2.14%)  3
Injury, poisoning and procedural complications     
Ligament sprain  1  6/142 (4.23%)  6 9/140 (6.43%)  9
Muscle strain  1  3/142 (2.11%)  3 7/140 (5.00%)  8
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/142 (6.34%)  10 16/140 (11.43%)  20
Back pain  1  8/142 (5.63%)  10 13/140 (9.29%)  14
Nervous system disorders     
Dizziness  1  9/142 (6.34%)  10 6/140 (4.29%)  6
Headache  1  20/142 (14.08%)  23 13/140 (9.29%)  29
Migraine  1  3/142 (2.11%)  3 9/140 (6.43%)  12
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/142 (4.93%)  7 9/140 (6.43%)  11
Oropharyngeal pain  1  2/142 (1.41%)  2 7/140 (5.00%)  8
1
Term from vocabulary, MedDRA 21
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Results Point of Contact
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Name/Title: Clinical Reporting Anchor and Disclosure (1452)
Organization: Novo Nordisk A/S
Phone: (+1) 866-867-7178
EMail: clinicaltrials@novonordisk.com
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02963935    
Other Study ID Numbers: NN8022-4274
U1111-1177-5059 ( Other Identifier: World Health Organization (WHO) )
First Submitted: November 10, 2016
First Posted: November 15, 2016
Results First Submitted: May 21, 2019
Results First Posted: July 30, 2019
Last Update Posted: March 11, 2020