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The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00700817
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : August 4, 2010
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: liraglutide
Drug: sitagliptin
Drug: metformin
Enrollment 665
Recruitment Details A total of 158 centres in 13 countries participated: Canada (11), Croatia (3), Germany (12), Ireland (5), Italy (8), Netherlands (8), Romania (4), Serbia (3), Slovakia (6), Slovenia (3), Spain (9), United Kingdom (20) and United States (66). Of the 158 sites approved by an Independent Ethics Committee, 151 actively screened and enrolled subjects.
Pre-assignment Details Between screening and randomisation, eligible subjects were to continue their usual pre-study metformin dose and dosing frequency.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Period Title: Week 0-26 (Main Period)
Started 225 [1] 221 [1] 219 [1] 0 0
Exposed 221 [2] 218 [3] 219 0 0
Completed 169 191 194 0 0
Not Completed 56 30 25 0 0
Reason Not Completed
Adverse Event             14             15             4             0             0
Lack of Efficacy             4             0             4             0             0
Protocol Violation             14             4             4             0             0
Withdrawal criteria             10             7             5             0             0
Unclassified             14             4             8             0             0
[1]
Randomised
[2]
4 subjects withdrew before exposure to trial drug and were not included in Full Analysis Set (FAS)
[3]
3 subjects withdrew before exposure to trial drug and were not included in Full Analysis Set (FAS)
Period Title: Week 26-52 (Extension Period 1)
Started 155 [1] 176 [1] 166 [1] 0 0
Completed 135 150 151 0 0
Not Completed 20 26 15 0 0
Reason Not Completed
Adverse Event             5             10             3             0             0
Protocol Violation             3             2             2             0             0
Lack of Efficacy             2             3             7             0             0
Withdrawal criteria             6             8             2             0             0
Unclassified             4             3             1             0             0
[1]
Subjects withdrew before entry to extension period 1
Period Title: Week 52-78 (Extension Period 2)
Started 134 [1] 150 0 [2] 67 [3] 68 [3]
Completed 124 135 0 59 63
Not Completed 10 15 0 8 5
Reason Not Completed
Adverse Event             0             3             0             6             0
Protocol Violation             1             2             0             1             1
Lack of Efficacy             3             3             0             0             0
Withdrawal criteria             4             3             0             1             3
Unclassified             2             4             0             0             1
[1]
Subject withdrew before entry to extension period 2
[2]
Re-randomised to lira 1.2 or 1.8 mg
[3]
Re-randomised from sita treatment group. Some subjects withdrew before entry to extension period 2.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg Total
Hide Arm/Group Description Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin. Total of all reporting groups
Overall Number of Baseline Participants 225 221 219 0 0 665
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 225 participants 221 participants 219 participants 0 participants 0 participants 665 participants
55.9  (9.6) 55.0  (9.1) 55.0  (9.0) 55.3  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants 221 participants 219 participants 0 participants 0 participants 665 participants
Female
109
  48.4%
105
  47.5%
99
  45.2%
313
  47.1%
Male
116
  51.6%
116
  52.5%
120
  54.8%
352
  52.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants 221 participants 219 participants 0 participants 0 participants 665 participants
Hispanic or Latino
39
  17.3%
34
  15.4%
35
  16.0%
108
  16.2%
Not Hispanic or Latino
186
  82.7%
187
  84.6%
184
  84.0%
557
  83.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants 221 participants 219 participants 0 participants 0 participants 665 participants
American Indian or Alaska Native
3
   1.3%
0
   0.0%
0
   0.0%
3
   0.5%
Asian
6
   2.7%
4
   1.8%
1
   0.5%
11
   1.7%
Native Hawaiian or Other Pacific Islander
1
   0.4%
0
   0.0%
1
   0.5%
2
   0.3%
Black or African American
22
   9.8%
16
   7.2%
10
   4.6%
48
   7.2%
White
184
  81.8%
193
  87.3%
199
  90.9%
576
  86.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
9
   4.0%
8
   3.6%
8
   3.7%
25
   3.8%
Body Mass Index (BMI) at Screening  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 225 participants 221 participants 219 participants 0 participants 0 participants 665 participants
32.6  (5.2) 33.1  (5.1) 32.6  (5.4) 32.8  (5.2)
Duration of Diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 225 participants 221 participants 219 participants 0 participants 0 participants 665 participants
6.0  (4.5) 6.4  (5.4) 6.3  (5.4) 6.2  (5.1)
[1]
Measure Description: The time (in years) the patient had been diagnosed with diabetes when screened for the trial
Fasting Plasma Glucose (FPG) at Randomisation  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 225 participants 221 participants 219 participants 0 participants 0 participants 665 participants
10.1  (2.4) 9.9  (2.4) 10.0  (2.0) 10.0  (2.3)
Glycosylated Haemoglobin A1c (HbA1c) at Randomisation  
Mean (Standard Deviation)
Unit of measure:  Percentage point of total HbA1c
Number Analyzed 225 participants 221 participants 219 participants 0 participants 0 participants 665 participants
8.4  (0.8) 8.4  (0.7) 8.5  (0.7) 8.4  (0.8)
1.Primary Outcome
Title Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Hide Description Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 211 214 210 0 0
Least Squares Mean (Standard Error)
Unit of Measure: Percentage point of total HbA1c
-1.24  (0.07) -1.5  (0.06) -0.9  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg, Sita -> Sita
Comments ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.
Statistical Test of Hypothesis P-Value 0.0001
Comments Multiple comparisons not applicable due to the hieracheal testing.
Method ANCOVA
Comments Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.6
Confidence Interval 95%
-0.77 to -0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg, Sita -> Sita
Comments ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.
Statistical Test of Hypothesis P-Value 0.0001
Comments Multiple comparisons not applicable due to the hieracheal testing.
Method ANCOVA
Comments Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.34
Confidence Interval 95%
-0.51 to -0.16
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 211 214 210 0 0
Least Squares Mean (Standard Error)
Unit of Measure: Percentage point of total HbA1c
-1.29  (0.07) -1.51  (0.07) -0.88  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg, Sita -> Sita
Comments ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.
Statistical Test of Hypothesis P-Value 0.0001
Comments Multiple comparisons not applicable due to the hieracheal testing.
Method ANCOVA
Comments Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
Method of Estimation Estimation Parameter Estimated Treatment Difference, LS Mean
Estimated Value -0.63
Confidence Interval 95%
-0.81 to -0.44
Estimation Comments Lira 1.8 - Sita
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg, Sita -> Sita
Comments ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.
Statistical Test of Hypothesis P-Value 0.0001
Comments Multiple comparisons not applicable due to the hieracheal testing.
Method ANCOVA
Comments Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).
Method of Estimation Estimation Parameter Estimated Treatment Difference, LS Mean
Estimated Value -0.40
Confidence Interval 95%
-0.59 to -0.22
Estimation Comments Lira 1.2 - Sita
3.Primary Outcome
Title Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Hide Description Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
Time Frame Week 0, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 211 214 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: Percentage point of total HbA1c
-0.94  (0.08) -1.28  (0.07)
4.Primary Outcome
Title Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Hide Description Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 67 68
Mean (Standard Deviation)
Unit of Measure: Percentage point of total HbA1c
-0.24  (0.7) -0.45  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sita -> Sita -> Lira 1.2 mg
Comments The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0060
Comments Multiple comparisons is not applicable.
Method paired t-test
Comments The analysis is not a controlled comparison, and there are no adjustments
Method of Estimation Estimation Parameter Change within treatment group
Estimated Value -0.24
Confidence Interval 95%
-0.41 to -0.07
Parameter Dispersion
Type: Standard Deviation
Value: 0.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sita -> Sita -> Lira 1.8 mg
Comments The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Multiple comparisons is not applicable.
Method paired t-test
Comments The analysis is not a controlled comparison, and there are no adjustments
Method of Estimation Estimation Parameter Change within treatment group
Estimated Value -0.45
Confidence Interval 95%
-0.67 to -0.23
Parameter Dispersion
Type: Standard Deviation
Value: 0.9
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
Hide Description Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 221 218 219 0 0
Measure Type: Number
Unit of Measure: percentage of subjects
43 55 22
6.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
Hide Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 211 214 210 0 0
Measure Type: Number
Unit of Measure: percentage of subjects
50 63 27
7.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Hide Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.
Time Frame Week 0, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 211 214 0 0 0
Measure Type: Number
Unit of Measure: percentage of subjects
35 51
8.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Hide Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.
Time Frame Week 0, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 67 68
Measure Type: Number
Unit of Measure: percentage of subjects
49 50
9.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
Hide Description Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 221 218 219 0 0
Measure Type: Number
Unit of Measure: percentage of subjects
23 36 12
10.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
Hide Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 211 214 210 0 0
Measure Type: Number
Unit of Measure: percentage of subjects
24 40 17
11.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Hide Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.
Time Frame Week 0, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 211 214 0 0 0
Measure Type: Number
Unit of Measure: percentage of subjects
12 27
12.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Hide Description Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.
Time Frame Week 0, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 67 68
Measure Type: Number
Unit of Measure: percentage of subjects
29 25
13.Secondary Outcome
Title Mean Change From Baseline in Body Weight at Week 26
Hide Description Calculated as an estimate of the mean change from baseline in body weight at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 215 214 215 0 0
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.86  (0.27) -3.38  (0.27) -0.96  (0.27)
14.Secondary Outcome
Title Mean Change From Baseline in Body Weight at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in body weight at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 215 214 215 0 0
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.78  (0.31) -3.68  (0.31) -1.16  (0.31)
15.Secondary Outcome
Title Mean Change in Body Weight From Week 52 to Week 78
Hide Description Mean change in body weight from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 67 68
Mean (Standard Deviation)
Unit of Measure: kg
-1.64  (3) -2.48  (3.6)
16.Secondary Outcome
Title Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Hide Description Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 210 212 210 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.87  (0.15) -2.14  (0.15) -0.83  (0.15)
17.Secondary Outcome
Title Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 210 212 209 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.71  (0.17) -2.04  (0.17) -0.59  (0.17)
18.Secondary Outcome
Title Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
Hide Description Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.
Time Frame Week 0, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 210 212 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.30  (0.18) -1.65  (0.18)
19.Secondary Outcome
Title Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
Hide Description Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 65 67
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.84  (1.8) -1.42  (2.1)
20.Secondary Outcome
Title Mean Change From Baseline in Beta-cell Function at Week 26
Hide Description

Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.

Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 196 208 201 0 0
Least Squares Mean (Standard Error)
Unit of Measure: percentage point
27.23  (3.82) 28.70  (3.75) 4.18  (3.79)
21.Secondary Outcome
Title Mean Change From Baseline in Beta-cell Function at Week 52
Hide Description

Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.

Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 196 208 200 0 0
Least Squares Mean (Standard Error)
Unit of Measure: percentage point
22.58  (3.31) 25.76  (3.25) 3.98  (3.30)
22.Secondary Outcome
Title Mean Change in Beta-cell Function From Week 52 to Week 78
Hide Description Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 64 64
Mean (Standard Deviation)
Unit of Measure: percentage point
13.31  (29.4) 23.09  (43.7)
23.Secondary Outcome
Title Mean Change From Baseline in Total Cholesterol at Week 26
Hide Description Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 194 202 201 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.03  (0.06) -0.17  (0.05) -0.02  (0.05)
24.Secondary Outcome
Title Mean Change From Baseline in Total Cholesterol at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 195 203 200 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.01  (0.06) -0.09  (0.06) 0.03  (0.06)
25.Secondary Outcome
Title Mean Change in Total Cholesterol From Week 52 to Week 78
Hide Description Mean change in total cholesterol from Week 52 to Week 78
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 65 67
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.16  (0.8) -0.24  (0.7)
26.Secondary Outcome
Title Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
Hide Description Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 194 202 200 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.08  (0.05) 0.05  (0.05) 0.13  (0.05)
27.Secondary Outcome
Title Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
Hide Description Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 195 203 199 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.09  (0.05) 0.09  (0.05) 0.17  (0.05)
28.Secondary Outcome
Title Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
Hide Description Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 65 67
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.22  (0.7) -0.25  (0.6)
29.Secondary Outcome
Title Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
Hide Description Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 194 201 201 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.00  (0.01) 0.00  (0.01) 0.00  (0.01)
30.Secondary Outcome
Title Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 195 202 200 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.01  (0.01) 0.02  (0.01) 0.01  (0.01)
31.Secondary Outcome
Title Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
Hide Description Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 65 67
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.02  (0.1) -0.01  (0.2)
32.Secondary Outcome
Title Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
Hide Description Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 194 201 199 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.11  (0.03) -0.20  (0.03) -0.15  (0.03)
33.Secondary Outcome
Title Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
Hide Description Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 195 202 198 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.11  (0.04) -0.19  (0.04) -0.15  (0.04)
34.Secondary Outcome
Title Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
Hide Description Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 65 67
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.03  (0.3) 0.02  (0.3)
35.Secondary Outcome
Title Mean Change From Baseline in Triglycerides (TG) at Week 26
Hide Description Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 191 199 198 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.19  (0.10) -0.43  (0.09) -0.40  (0.09)
36.Secondary Outcome
Title Mean Change From Baseline in Triglycerides (TG) at Week 52
Hide Description Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 194 200 197 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.10  (0.10) -0.32  (0.10) -0.23  (0.10)
37.Secondary Outcome
Title Mean Change in Triglycerides (TG) From Week 52 to Week 78
Hide Description Mean change in triglycerides (TG) from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 64 66
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.20  (0.8) -0.26  (0.8)
38.Secondary Outcome
Title Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
Hide Description Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 147 149 158 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.03  (0.02) -0.07  (0.02) -0.05  (0.02)
39.Secondary Outcome
Title Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
Hide Description Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 170 177 176 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.07  (0.02) -0.10  (0.02) -0.06  (0.02)
40.Secondary Outcome
Title Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
Hide Description Mean change in free fatty acids (FFA) from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 60 65
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.02  (0.3) -0.01  (0.3)
41.Secondary Outcome
Title Mean Change From Baseline in Apolipoprotein B at Week 26
Hide Description Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 164 175 182 0 0
Least Squares Mean (Standard Error)
Unit of Measure: g/L
-0.06  (0.01) -0.07  (0.01) -0.05  (0.01)
42.Secondary Outcome
Title Mean Change From Baseline in Apolipoprotein B at Week 52
Hide Description Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 184 192 195 0 0
Least Squares Mean (Standard Error)
Unit of Measure: g/L
-0.03  (0.01) -0.03  (0.01) -0.03  (0.01)
43.Secondary Outcome
Title Mean Change in Apolipoprotein B From Week 52 to Week 78
Hide Description Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 66 68
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.23  (0.4) 0.17  (0.4)
44.Secondary Outcome
Title Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
Hide Description Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 205 209 205 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
-1.02  (0.31) -0.99  (0.31) -0.66  (0.31)
45.Secondary Outcome
Title Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
Hide Description Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 188 198 182 0 0
Least Squares Mean (Standard Error)
Unit of Measure: U/L
-833  (945.1) -561  (941.1) 586  (952)
46.Secondary Outcome
Title Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
Hide Description Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 204 210 206 0 0
Least Squares Mean (Standard Error)
Unit of Measure: pg/mL
-1.70  (2.49) 1.71  (2.47) 0.91  (2.49)
47.Secondary Outcome
Title Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Hide Description Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 204 209 205 0 0
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
5.19  (2.07) 3.74  (2.06) 3.71  (2.07)
48.Secondary Outcome
Title Mean Change From Baseline in Adiponectin at Week 26.
Hide Description Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 202 210 207 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mcg/mL
1.69  (0.19) 1.51  (0.19) 1.35  (0.19)
49.Secondary Outcome
Title Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Hide Description Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 195 204 196 0 0
Least Squares Mean (Standard Error)
Unit of Measure: pg/mL
-0.55  (0.25) -0.74  (0.25) -0.53  (0.25)
50.Secondary Outcome
Title Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
Hide Description Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 189 193 183 0 0
Least Squares Mean (Standard Error)
Unit of Measure: percentage point
-1.73  (2.77) -4.34  (2.76) -1.8  (2.82)
51.Secondary Outcome
Title Mean Change From Baseline in Waist to Hip Ratio at Week 26.
Hide Description Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 210 208 207 0 0
Least Squares Mean (Standard Error)
Unit of Measure: cm/cm
-0.01  (0.00) -0.01  (0.00) -0.00  (0.00)
52.Secondary Outcome
Title Mean Change From Baseline in Waist to Hip Ratio at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 210 208 207 0 0
Least Squares Mean (Standard Error)
Unit of Measure: cm/cm
-0.00  (0.00) -0.01  (0.00) -0.00  (0.00)
53.Secondary Outcome
Title Mean Change in Waist to Hip Ratio From Week 52 to Week 78
Hide Description Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 66 67
Mean (Standard Deviation)
Unit of Measure: cm/cm
-0.01  (0) -0.00  (0)
54.Secondary Outcome
Title Mean Change From Baseline in Waist Circumference at Week 26.
Hide Description Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 210 208 208 0 0
Least Squares Mean (Standard Error)
Unit of Measure: cm
-2.69  (0.35) -2.63  (0.36) -1.12  (0.36)
55.Secondary Outcome
Title Mean Change From Baseline in Waist Circumference at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 210 208 208 0 0
Least Squares Mean (Standard Error)
Unit of Measure: participants
-2.36  (0.38) -3.02  (0.38) -1.23  (0.38)
56.Secondary Outcome
Title Mean Change in Waist Circumference From Week 52 to Week 78
Hide Description Mean change in Waist Circumference from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 66 68
Mean (Standard Deviation)
Unit of Measure: kg
-1.33  (3.5) -2.05  (4.1)
57.Secondary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Hide Description Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 213 214 213 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.55  (0.89) -0.72  (0.89) -0.94  (0.89)
58.Secondary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 213 214 213 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.37  (0.93) -2.55  (0.93) -1.03  (0.93)
59.Secondary Outcome
Title Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
Hide Description Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 67 68
Mean (Standard Deviation)
Unit of Measure: mmHg
-2.12  (14.6) 0.35  (12.4)
60.Secondary Outcome
Title Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Hide Description Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 213 214 213 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.71  (0.60) 0.07  (0.59) -1.78  (0.60)
61.Secondary Outcome
Title Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 213 214 213 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.53  (0.57) -0.87  (0.57) -1.47  (0.57)
62.Secondary Outcome
Title Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
Hide Description Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 67 68
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.60  (10.0) 0.03  (8.9)
63.Secondary Outcome
Title Mean Change From Baseline in Pulse at Week 26
Hide Description Calculated as an estimate of the mean change from baseline in pulse at Week 26.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 212 214 211 0 0
Least Squares Mean (Standard Error)
Unit of Measure: beats/minute
2.32  (0.59) 3.94  (0.58) -0.64  (0.59)
64.Secondary Outcome
Title Mean Change From Baseline in Pulse at Week 52
Hide Description Calculated as an estimate of the mean change from baseline in pulse at Week 52.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 212 214 211 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
1.72  (0.60) 3.09  (0.60) 0.09  (0.60)
65.Secondary Outcome
Title Mean Change in Pulse From Week 52 to Week 78
Hide Description Mean change in pulse from Week 52 to Week 78.
Time Frame Week 52, Week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 0 0 0 67 68
Mean (Standard Deviation)
Unit of Measure: beats/minute
0.90  (8.4) 2.19  (7.7)
66.Secondary Outcome
Title Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
Hide Description The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia
Arm/Group Title Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Sita -> Sita Sita -> Sita -> Lira 1.2 mg Sita -> Sita -> Lira 1.8 mg
Hide Arm/Group Description:
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Overall Number of Participants Analyzed 164 171 170 0 0
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
3.51  (0.49) 4.35  (0.48) 2.96  (0.48)
67.Secondary Outcome
Title Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
Hide Description The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time Frame Week 0, Week 52