Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes

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: NCT01272232
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : February 9, 2015
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Metabolism and Nutrition Disorder
Obesity
Interventions Drug: liraglutide
Drug: placebo
Enrollment 846
Recruitment Details A total of 126 sites in 9 countries participated: France (7), Germany (10), Israel (5), South Africa (6), Spain (8), Sweden (5), Turkey (3), United Kingdom (15), United States (67).
Pre-assignment Details If eligible based on screened assessments, subjects were randomised to 1 of the 3 treatment arms in a 2:1:1 manner (liraglutide 3.0 mg, liraglutide 1.8 mg and placebo, respectively).
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%. Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%. Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Period Title: Weeks 0-56
Started 423 211 212
Exposed 422 [1] 210 [1] 212
Completed 324 164 140
Not Completed 99 47 72
Reason Not Completed
Adverse Event             39             18             7
Lack of Efficacy             0             0             3
Protocol Violation             12             8             13
Withdrawal criteria             32             14             37
Unclassified             16             7             12
[1]
1 subject dropped out after randomisation and before exposure to trial drug.
Period Title: Off Drug Follow-up Period (Weeks 56-68)
Started 324 164 140
Completed 310 154 135
Not Completed 14 10 5
Reason Not Completed
Adverse Event             1             1             0
Lack of Efficacy             1             0             0
Protocol Violation             1             0             1
Withdrawal criteria             9             7             4
Unclassified             2             2             0
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo Total
Hide Arm/Group Description Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%. Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%. Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%. Total of all reporting groups
Overall Number of Baseline Participants 423 211 212 846
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 423 participants 211 participants 212 participants 846 participants
55.0  (10.8) 54.9  (10.7) 54.7  (9.8) 54.9  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 423 participants 211 participants 212 participants 846 participants
Female
203
  48.0%
103
  48.8%
115
  54.2%
421
  49.8%
Male
220
  52.0%
108
  51.2%
97
  45.8%
425
  50.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 423 participants 211 participants 212 participants 846 participants
Hispanic or Latino
46
  10.9%
17
   8.1%
24
  11.3%
87
  10.3%
Not Hispanic or Latino
375
  88.7%
194
  91.9%
187
  88.2%
756
  89.4%
Unknown or Not Reported
2
   0.5%
0
   0.0%
1
   0.5%
3
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 423 participants 211 participants 212 participants 846 participants
American Indian or Alaska Native
4
   0.9%
0
   0.0%
0
   0.0%
4
   0.5%
Asian
11
   2.6%
4
   1.9%
4
   1.9%
19
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
44
  10.4%
27
  12.8%
27
  12.7%
98
  11.6%
White
353
  83.5%
177
  83.9%
175
  82.5%
705
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
   2.6%
3
   1.4%
6
   2.8%
20
   2.4%
Age group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 423 participants 211 participants 212 participants 846 participants
18- < 40 years 38 15 13 66
40- < 65 years 300 162 161 623
65- < 75 years 74 32 36 142
>= 75 years 11 2 2 15
Fasting body weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 423 participants 211 participants 212 participants 846 participants
105.7  (21.9) 105.8  (21.0) 106.5  (21.3) 105.9  (21.5)
[1]
Measure Description: Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  m
Number Analyzed 423 participants 211 participants 212 participants 846 participants
1.69  (0.11) 1.69  (0.10) 1.69  (0.10) 1.69  (0.10)
[1]
Measure Description: Height was recorded without shoes.
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 423 participants 211 participants 212 participants 846 participants
37.1  (6.5) 37.0  (6.9) 37.4  (7.1) 37.1  (6.8)
Body Mass Index (BMI) group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 423 participants 211 participants 212 participants 846 participants
25.0-29.9 kg/m^2 - pre-obese 52 34 30 116
30.0-34.9 kg/m^2 - obese class I 139 62 59 260
35.0-39.9 kg/m^2 - obese class II 108 50 60 218
>40.0 kg/m^2 - obese class III 124 65 63 252
HbA1c (glycosylated haemoglobin)  
Mean (Standard Deviation)
Unit of measure:  Percent (%) glycosylated haemoglobin
Number Analyzed 423 participants 211 participants 212 participants 846 participants
7.9  (0.8) 8.0  (0.8) 7.9  (0.8) 7.9  (0.8)
Fasting plasma glucose  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 423 participants 211 participants 212 participants 846 participants
8.8  (1.9) 8.9  (2.0) 8.6  (1.8) 8.8  (1.9)
Co-morbid hypertension   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 423 participants 211 participants 212 participants 846 participants
Present 293 148 145 586
Absent 130 63 67 260
[1]
Measure Description: Presence or absence of untreated or treated hypertension
Co-morbid dyslipidaemia   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 423 participants 211 participants 212 participants 846 participants
Present 295 143 126 564
Absent 128 68 86 282
[1]
Measure Description: Presence or absence of untreated or treated dyslipidaemia
Duration of diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 423 participants 211 participants 212 participants 846 participants
7.54  (5.65) 7.43  (5.16) 6.71  (5.07) 7.30  (5.39)
1.Primary Outcome
Title Change (%) From Baseline in Body Weight (Fasting)
Hide Description Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 412 204 211
Mean (Standard Deviation)
Unit of Measure: percent change
-5.9  (5.5) -4.6  (5.5) -2.0  (4.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide Placebo
Comments The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -3.97
Confidence Interval 95%
-4.84 to -3.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide Placebo
Comments The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -2.62
Confidence Interval 95%
-3.63 to -1.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide 1.8 mg
Comments The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -1.35
Confidence Interval 95%
-2.23 to -0.48
Estimation Comments [Not Specified]
2.Primary Outcome
Title Proportion of Subjects Losing at Least 5% of Baseline Body Weight
Hide Description Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time Frame at 56 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 412 204 211
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 49.9 35.6 13.8
No 50.1 64.4 86.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide Placebo
Comments The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.81
Confidence Interval 95%
4.34 to 10.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide Placebo
Comments The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.69
Confidence Interval 95%
2.24 to 6.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide 1.8 mg
Comments The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.84
Confidence Interval 95%
1.29 to 2.64
Estimation Comments [Not Specified]
3.Primary Outcome
Title Proportion of Subjects Losing More Than 10% of Baseline Body Weight
Hide Description Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time Frame at 56 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 412 204 211
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 23.4 14.4 4.3
No 76.6 85.6 95.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide Placebo
Comments The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.10
Confidence Interval 95%
3.48 to 14.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide Placebo
Comments The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.84
Confidence Interval 95%
1.75 to 8.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide 1.8 mg
Comments The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0099
Comments Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.85
Confidence Interval 95%
1.16 to 2.95
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)
Hide Description Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 412 204 211
Mean (Standard Deviation)
Unit of Measure: percentage point change of HbA1c
-1.3  (0.9) -1.1  (1.0) -0.3  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -0.93
Confidence Interval 95%
-1.08 to -0.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -0.74
Confidence Interval 95%
-0.91 to -0.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide 1.8 mg
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0125
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -0.19
Confidence Interval 95%
-0.34 to -0.04
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Subjects Reaching Target HbA1c Below 7%
Hide Description [Not Specified]
Time Frame at 56 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 412 204 211
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 69.2 66.7 27.2
No 30.8 33.3 72.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.79
Confidence Interval 95%
5.74 to 13.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.71
Confidence Interval 95%
4.76 to 12.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide 1.8 mg
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5319
Comments p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.14
Confidence Interval 95%
0.76 to 1.71
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%
Hide Description [Not Specified]
Time Frame at 56 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 412 204 211
Measure Type: Number
Unit of Measure: percentage of subjects
Yes 56.5 45.6 15.0
No 43.5 54.4 85.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 9.61
Confidence Interval 95%
6.05 to 15.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.98
Confidence Interval 95%
3.59 to 9.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide 1.8 mg
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0142
Comments p values are 2-sided; 5% pre-defined significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.61
Confidence Interval 95%
1.10 to 2.34
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Waist Circumference
Hide Description [Not Specified]
Time Frame Week 0, week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 412 204 211
Mean (Standard Deviation)
Unit of Measure: cm
-6.1  (6.5) -4.8  (5.6) -2.7  (5.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -3.22
Confidence Interval 95%
-4.20 to -2.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -2.06
Confidence Interval 95%
-3.20 to -0.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide 1.8 mg
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0224
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -1.16
Confidence Interval 95%
-2.16 to -0.16
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change (%) From Baseline in Body Weight (Fasting)
Hide Description Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time Frame Week 0, week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 324 164 140
Mean (Standard Deviation)
Unit of Measure: percent change
-4.7  (5.0) -3.6  (5.7) -2.7  (5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -2.17
Confidence Interval 95%
-3.32 to -1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0725
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -1.20
Confidence Interval 95%
-2.51 to 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide 1.8 mg
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0717
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -0.97
Confidence Interval 95%
-2.02 to 0.09
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change (%) From Week 56 to 68 in Body Weight (Fasting)
Hide Description Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.
Time Frame Week 56, week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 324 164 140
Mean (Standard Deviation)
Unit of Measure: percent change
2.3  (2.9) 2.0  (2.9) -0.1  (2.2)
10.Secondary Outcome
Title Change From Baseline in Waist Circumference
Hide Description [Not Specified]
Time Frame Week 0, week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 324 164 140
Mean (Standard Deviation)
Unit of Measure: cm
-5.7  (6.3) -4.4  (6.0) -3.2  (6.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -2.49
Confidence Interval 95%
-3.75 to -1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Liraglutide 1.8 mg, Liraglutide Placebo
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0457
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -1.47
Confidence Interval 95%
-2.92 to -0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Liraglutide 1.8 mg
Comments Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0961
Comments p values are 2-sided; 5% pre-defined significance level.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -1.02
Confidence Interval 95%
-2.22 to 0.18
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Week 56 to 68 in Waist Circumference
Hide Description [Not Specified]
Time Frame Week 56, week 68
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 324 164 140
Mean (Standard Deviation)
Unit of Measure: cm
1.21  (3.94) 1.02  (3.55) -0.22  (3.23)
12.Secondary Outcome
Title Incidence of Hypoglycaemic Episodes
Hide Description Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]).
Time Frame Weeks 0-56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set, comprising all randomised subjects who had been exposed to at least one dose of trial product.
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description:
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
Overall Number of Participants Analyzed 422 210 212
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
Minor 34 46 13
ADA: Severe 1 2 0
ADA: Documented, symptomatic 87 95 31
ADA: Asymptomatic 151 142 46
ADA: Probable, symptomatic 2 2 1
ADA: Relative 17 16 5
ADA: Unclassifiable 14 7 3
Time Frame Adverse events were recorded for up to 68 weeks.
Adverse Event Reporting Description Safety Analysis Set comprising all randomised subjects who had been exposed to at least one dose of trial product.
 
Arm/Group Title Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Hide Arm/Group Description Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%. Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%. Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
All-Cause Mortality
Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/422 (8.77%)      18/210 (8.57%)      13/212 (6.13%)    
Cardiac disorders       
Angina pectoris  1  1/422 (0.24%)  2 0/210 (0.00%)  0 0/212 (0.00%)  0
Angina unstable  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Arteriosclerosis coronary artery  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Cardiomyopathy  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Coronary artery disease  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Coronary artery stenosis  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Myocardial infarction  1  1/422 (0.24%)  1 2/210 (0.95%)  2 1/212 (0.47%)  1
Ear and labyrinth disorders       
Meniere  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Eye disorders       
Ulcerative keratitis  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Abdominal pain upper  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Colonic polyp  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Gastrooesophageal reflux disease  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Oesophageal ulcer  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
General disorders       
Chest discomfort  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Chest pain  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Non-cardiac chest pain  1  2/422 (0.47%)  2 0/210 (0.00%)  0 0/212 (0.00%)  0
Hepatobiliary disorders       
Bile duct obstruction  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Cholecystitis acute  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Cholelithiasis  1  3/422 (0.71%)  3 1/210 (0.48%)  1 0/212 (0.00%)  0
Infections and infestations       
Appendicitis  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Arthritis infective  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Bronchitis  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Erysipelas  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Lobar pneumonia  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Viral upper respiratory tract infection  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Injury, poisoning and procedural complications       
Coronary artery restenosis  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Fall  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Joint injury  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Spinal compression fracture  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Investigations       
Blood calcitonin increased  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Catheterisation cardiac  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Pancreatic enzymes increased  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Metabolism and nutrition disorders       
Hyperglycaemia  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Hyperlipasaemia  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Back pain  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Flank pain  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Osteoarthritis  1  1/422 (0.24%)  1 2/210 (0.95%)  2 0/212 (0.00%)  0
Osteonecrosis  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Synovitis  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Tendon disorder  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon adenoma  1  1/422 (0.24%)  2 0/210 (0.00%)  0 0/212 (0.00%)  0
Hepatic neoplasm malignant  1  1/422 (0.24%)  1 0/210 (0.00%)  0 1/212 (0.47%)  1
Leiomyoma  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Prostate cancer  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Prostate cancer recurrent  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Rectal cancer  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Thyroid adenoma  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Thyroid cancer  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Uterine leiomyoma  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident  1  0/422 (0.00%)  0 1/210 (0.48%)  1 1/212 (0.47%)  1
Ischaemic stroke  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Syncope  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Transient ischaemic attack  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Psychiatric disorders       
Panic attack  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Renal and urinary disorders       
Bladder prolapse  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Calculus ureteric  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Diabetic nephropathy  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Nephrolithiasis  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Urinary retention  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Reproductive system and breast disorders       
Adenomyosis  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Menorrhagia  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/422 (0.00%)  0 1/210 (0.48%)  1 1/212 (0.47%)  1
Bronchospasm  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Chronic obstructive pulmonary disease  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Dyspnoea  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Surgical and medical procedures       
Angioplasty  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Coronary arterial stent insertion  1  0/422 (0.00%)  0 0/210 (0.00%)  0 1/212 (0.47%)  1
Coronary revascularisation  1  2/422 (0.47%)  2 0/210 (0.00%)  0 1/212 (0.47%)  2
Inguinal hernia repair  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Nasal operation  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Percutaneous coronary intervention  1  0/422 (0.00%)  0 1/210 (0.48%)  1 0/212 (0.00%)  0
Vascular disorders       
Deep vein thrombosis  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Peripheral arterial occlusive disease  1  1/422 (0.24%)  1 0/210 (0.00%)  0 0/212 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Liraglutide 3.0 mg Liraglutide 1.8 mg Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   361/422 (85.55%)      173/210 (82.38%)      164/212 (77.36%)    
Gastrointestinal disorders       
Abdominal distension  1  26/422 (6.16%)  32 10/210 (4.76%)  11 3/212 (1.42%)  3
Abdominal pain  1  26/422 (6.16%)  34 4/210 (1.90%)  4 9/212 (4.25%)  9
Abdominal pain upper  1  15/422 (3.55%)  21 14/210 (6.67%)  17 2/212 (0.94%)  2
Constipation  1  68/422 (16.11%)  78 20/210 (9.52%)  24 13/212 (6.13%)  14
Diarrhoea  1  108/422 (25.59%)  173 37/210 (17.62%)  50 27/212 (12.74%)  35
Dyspepsia  1  47/422 (11.14%)  59 14/210 (6.67%)  16 5/212 (2.36%)  5
Flatulence  1  22/422 (5.21%)  26 8/210 (3.81%)  8 4/212 (1.89%)  4
Nausea  1  138/422 (32.70%)  208 66/210 (31.43%)  84 29/212 (13.68%)  34
Vomiting  1  66/422 (15.64%)  113 21/210 (10.00%)  27 12/212 (5.66%)  14
General disorders       
Fatigue  1  35/422 (8.29%)  45 11/210 (5.24%)  11 7/212 (3.30%)  7
Injection site haematoma  1  19/422 (4.50%)  33 4/210 (1.90%)  4 12/212 (5.66%)  14
Infections and infestations       
Bronchitis  1  13/422 (3.08%)  14 12/210 (5.71%)  16 11/212 (5.19%)  15
Influenza  1  22/422 (5.21%)  24 12/210 (5.71%)  14 15/212 (7.08%)  16
Nasopharyngitis  1  88/422 (20.85%)  134 34/210 (16.19%)  46 41/212 (19.34%)  54
Sinusitis  1  16/422 (3.79%)  19 15/210 (7.14%)  18 18/212 (8.49%)  22
Upper respiratory tract infection  1  40/422 (9.48%)  49 23/210 (10.95%)  25 18/212 (8.49%)  19
Urinary tract infection  1  19/422 (4.50%)  34 13/210 (6.19%)  17 12/212 (5.66%)  14
Investigations       
Lipase increased  1  50/422 (11.85%)  56 22/210 (10.48%)  26 14/212 (6.60%)  16
Metabolism and nutrition disorders       
Decreased appetite  1  40/422 (9.48%)  44 23/210 (10.95%)  23 4/212 (1.89%)  4
Hypoglycaemia  1  187/422 (44.31%)  981 84/210 (40.00%)  429 59/212 (27.83%)  154
Musculoskeletal and connective tissue disorders       
Arthralgia  1  30/422 (7.11%)  42 17/210 (8.10%)  25 12/212 (5.66%)  15
Back pain  1  42/422 (9.95%)  67 27/210 (12.86%)  36 20/212 (9.43%)  27
Musculoskeletal pain  1  22/422 (5.21%)  24 9/210 (4.29%)  10 6/212 (2.83%)  7
Pain in extremity  1  16/422 (3.79%)  20 12/210 (5.71%)  13 10/212 (4.72%)  12
Nervous system disorders       
Dizziness  1  30/422 (7.11%)  39 10/210 (4.76%)  15 6/212 (2.83%)  7
Headache  1  66/422 (15.64%)  125 26/210 (12.38%)  42 29/212 (13.68%)  40
Respiratory, thoracic and mediastinal disorders       
Cough  1  18/422 (4.27%)  21 12/210 (5.71%)  16 8/212 (3.77%)  9
Vascular disorders       
Hypertension  1  12/422 (2.84%)  12 7/210 (3.33%)  8 11/212 (5.19%)  12
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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.
Novo Nordisk reserves the right not to release data until specified milestones are available. This includes the right not to release interim results from clinical trials, as such results may lead to conclusions that are later proven incorrect. At the end of the trial, one or more manuscripts for publication will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to briefly postpone publication or communication to protect intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Publications of Results:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272232    
Other Study ID Numbers: NN8022-1922
2008-002199-88 ( EudraCT Number )
U1111-1118-7963 ( Other Identifier: WHO )
First Submitted: January 6, 2011
First Posted: January 7, 2011
Results First Submitted: January 22, 2015
Results First Posted: February 9, 2015
Last Update Posted: December 29, 2017