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The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00856986
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : May 13, 2011
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: insulin detemir
Drug: metformin
Enrollment 987
Recruitment Details A total of 202 centres in 9 countries: Belgium (2), Canada (7), France (19), Germany (37), Italy (18), the Netherlands (16), Spain (14), the United Kingdom (32) and the United States (57)
Pre-assignment Details Subjects on metformin and/or sulpholynurea treatment underwent a 12-week run-in period with liraglutide + metformin. Subjects not achieving an HbA1c below 7% were randomised to liraglutide + metformin treatment with/without insulin detemir. Subjects achieving an HbA1c below 7% continued liraglutide + metformin treatment.
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0% Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0% Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0% Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Period Title: Run-in Period, Weeks -12-0
Started 161 162 498 167 0
Completed 161 162 498 0 [1] 0
Not Completed 0 0 0 167 0
Reason Not Completed
Adverse Event             0             0             0             92             0
Protocol Violation             0             0             0             24             0
Withdrawal Criteria             0             0             0             10             0
Lost to Follow-up             0             0             0             11             0
Lack of Efficacy             0             0             0             6             0
Unclassified             0             0             0             24             0
[1]
Subjects who withdrew during run-in and before randomisation were Early Withdrawals
Period Title: Main Period, Weeks 0-26
Started 161 162 498 0 0
Completed 127 144 470 0 0
Not Completed 34 18 28 0 0
Reason Not Completed
Adverse Event             6             4             9             0             0
Protocol Violation             4             5             7             0             0
Withdrawal Criteria             11             0             3             0             0
Lost to Follow-up             1             1             2             0             0
Lack of Efficacy             5             2             0             0             0
Unclassified             7             6             7             0             0
Period Title: Extension Period, Weeks 26-52
Started 127 [1] 144 470 [2] 0 0
Enrolled in Extension 122 140 461 0 0
Completed 108 130 432 0 0
Not Completed 19 14 38 0 0
Reason Not Completed
Adverse Event             3             3             10             0             0
Protocol Violation             6             2             5             0             0
Withdrawal Criteria             2             0             8             0             0
Lost to Follow-up             0             5             2             0             0
Lack of Efficacy             4             2             2             0             0
Unclassified             4             2             11             0             0
[1]
Subjects with HbA1c ≥8.0% who accepted intensification with detemir = 17 (Intensified Group)
[2]
Subjects with HbA1c ≥8.0% who accepted intensification with detemir = 7 (Intensified Group)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group Total
Hide Arm/Group Description Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0% Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0% Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0% Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group. Total of all reporting groups
Overall Number of Baseline Participants 161 162 498 166 24 1011
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
57.5  (9.8) 57  (9.5) 56.7  (9.7) 58.7  (10.8) 54.3  (10.3) 56.9  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
Female
72
  44.7%
74
  45.7%
216
  43.4%
75
  45.2%
11
  45.8%
448
  44.3%
Male
89
  55.3%
88
  54.3%
282
  56.6%
91
  54.8%
13
  54.2%
563
  55.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
Hispanic or Latino
25
  15.5%
22
  13.6%
48
   9.6%
28
  16.9%
5
  20.8%
128
  12.7%
Not Hispanic or Latino
136
  84.5%
140
  86.4%
450
  90.4%
138
  83.1%
19
  79.2%
883
  87.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
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 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
American Indian or Alaska Native
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
Asian
1
   0.6%
4
   2.5%
5
   1.0%
4
   2.4%
0
   0.0%
14
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
17
  10.6%
8
   4.9%
19
   3.8%
11
   6.6%
1
   4.2%
56
   5.5%
White
141
  87.6%
144
  88.9%
470
  94.4%
146
  88.0%
22
  91.7%
923
  91.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.2%
4
   2.5%
4
   0.8%
5
   3.0%
1
   4.2%
16
   1.6%
Height  
Mean (Standard Deviation)
Unit of measure:  Meter
Number Analyzed 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
1.7  (0.1) 1.69  (0.11) 1.7  (0.1) 1.68  (0.1) 1.72  (0.09) 1.69  (0.1)
Body weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
98.6  (21.3) 99.5  (21.2) 99  (20.8) 90.2  (18.5) 109  (25.7) 99  (21)
[1]
Measure Description: At Week -12
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
33.9  (6) 34.9  (6.3) 34.4  (6.7) 31.8  (6) 36.5  (7.7) 34.4  (6.5)
[1]
Measure Description: At Week -12
Diabetes History  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
8.5  (6) 8.6  (5.8) 6.6  (5.7) 8.4  (6.4) 6.8  (5.4) 7.4  (5.8)
Glycosylated haemoglobin (HbA1c)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage point of total HbA1c
Number Analyzed 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
8.3  (0.8) 8.2  (0.7) 7.7  (0.7) 8  (0.8) 8.4  (0.7) 7.9  (0.8)
[1]
Measure Description: At Week -12
Fasting plasma glucose (FPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 161 participants 162 participants 498 participants 166 participants 24 participants 1011 participants
10.3  (2.5) 10.2  (2.4) 9.2  (1.8) 9.5  (3) 10.4  (2.3) 9.6  (2.1)
[1]
Measure Description: At Week -12
1.Primary Outcome
Title Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 149 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: Percentage point of total HbA1c
0.02  (0.07) -0.51  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Insulin Detemir + Lira 1.8
Comments The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5% and with the power of 90%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Difference, LSMean
Estimated Value -0.52
Confidence Interval 95%
-0.68 to -0.36
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 149 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: Percentage point of total HbA1c
-0.1  (0.09) -0.51  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Insulin Detemir + Lira 1.8
Comments The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Difference, LSMean
Estimated Value -0.41
Confidence Interval 95%
-0.6 to -0.21
Estimation Comments The analysis values for intensified Lira 1.8 mg subjects were kept in the treatment group and the last observation carried forward (LOCF) method was applied.
3.Secondary Outcome
Title Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) includes LOCF of last observation before intensification for randomised Lira 1.8 mg treatment group subjects who were intensified.
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 149 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: Percentage point of total HbA1c
0.01  (0.09) -0.5  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Insulin Detemir + Lira 1.8
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS mean
Estimated Value -0.51
Confidence Interval 95%
-0.7 to -0.31
Estimation Comments The mean change in HbA1c from randomisation to week 52 was analysed including the values before intensification as LOCF for intensified subjects
4.Secondary Outcome
Title Mean Change From Randomisation in Fasting Plasma Glucose at Week 26
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 154 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.39  (0.19) -2.12  (0.19)
5.Secondary Outcome
Title Mean Change From Randomisation in Fasting Plasma Glucose at Week 52
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 154 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.14  (0.21) -1.91  (0.21)
6.Secondary Outcome
Title Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
Hide Description Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 133 144 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
Change at Breakfast, N=133, 144 -0.97  (0.26) -2.09  (0.26)
Change at Lunch, N= 134, 143 -0.83  (0.22) -1.43  (0.22)
Change at Dinner, N= 133, 139 -0.48  (0.24) -1.18  (0.24)
7.Secondary Outcome
Title Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52
Hide Description Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 136 148 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
Change at Breakfast, N=148, 135 -0.68  (0.25) -2.43  (0.25)
Change at Lunch, N= 145, 136 -0.51  (0.25) -1.14  (0.25)
Change at Dinner, N= 144, 135 -0.96  (0.26) -1.4  (0.25)
8.Secondary Outcome
Title Mean Change From Randomisation in Fasting Insulin at Week 26
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Mean Change From Randomisation in Fasting Insulin at Week 52
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Mean Change From Randomisation in Fasting Pro-insulin at Week 26.
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 135 152 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
-1.12  (3.27) -9.78  (3.22)
11.Secondary Outcome
Title Mean Change From Randomisation in Fasting Pro-insulin at Week 52
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 139 152 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
1.47  (3.08) -4  (3.08)
12.Secondary Outcome
Title Mean Change From Randomisation in Fasting C-peptide at Week 26.
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 136 149 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.08  (0.04) -0.32  (0.04)
13.Secondary Outcome
Title Mean Change From Randomisation in Fasting C-peptide at Week 52.
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 139 150 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.02  (0.05) -0.34  (0.05)
14.Secondary Outcome
Title Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
Hide Description Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 141 152 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
Change in Total Cholesterol 0.04  (0.07) 0.05  (0.07)
Change in LDL-C -0.04  (0.06) -0.03  (0.06)
Change in VLDL-C 0.05  (0.03) 0.01  (0.03)
Change in HDL-C 0.02  (0.01) 0.05  (0.01)
15.Secondary Outcome
Title Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
Hide Description Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 141 153 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
Change in Total Cholesterol -0.02  (0.08) -0.03  (0.08)
Change in LDL-C -0.08  (0.07) -0.1  (0.07)
Change in VLDL-C 0.03  (0.04) -0.03  (0.04)
Change in HDL-C 0.02  (0.02) 0.07  (0.02)
16.Secondary Outcome
Title Mean Change From Randomisation in Lipids: Triglycerides at Week 26
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 141 151 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.24  (0.11) -0.33  (0.11)
17.Secondary Outcome
Title Mean Change From Randomisation in Lipids: Triglycerides at Week 52
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 141 152 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.22  (0.11) -0.37  (0.11)
18.Secondary Outcome
Title Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 131 140 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.03  (0.02) -0.11  (0.02)
19.Secondary Outcome
Title Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 133 141 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.03  (0.03) -0.07  (0.03)
20.Secondary Outcome
Title Mean Change From Randomisation in Body Weight at Week 26
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 157 162 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: kg
-0.95  (0.31) -0.16  (0.31)
21.Secondary Outcome
Title Mean Change From Randomisation in Body Weight at Week 52
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (last observation carried forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 157 162 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: kg
-1.02  (0.41) -0.05  (0.42)
22.Secondary Outcome
Title Mean Change From Randomisation in Waist Circumference at Week 26.
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 148 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: cm
-0.66  (0.46) -0.78  (0.46)
23.Secondary Outcome
Title Mean Change From Randomisation in Waist Circumference at Week 52.
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 148 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: participants
-0.83  (0.54) -0.83  (0.53)
24.Secondary Outcome
Title Mean Change From Randomisation in Hip Circumference at Week 26
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 148 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: cm
-0.36  (0.46) -0.38  (0.45)
25.Secondary Outcome
Title Mean Change From Randomisation in Hip Circumference at Week 52
Hide Description [Not Specified]
Time Frame Week 0, week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 148 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: cm
-0.79  (0.5) -0.28  (0.49)
26.Secondary Outcome
Title Mean Change From Randomisation in Waist to Hip Ratio at Week 26
Hide Description Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 148 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: cm/cm
-0.00356  (0.004071) -0.00332  (0.004032)
27.Secondary Outcome
Title Mean Change From Randomisation in Waist to Hip Ratio at Week 52
Hide Description Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 148 160 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: cm/cm
-0.00146  (0.004165) -0.00438  (0.004126)
28.Secondary Outcome
Title Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.
Hide Description [Not Specified]
Time Frame Week 0 (Randomisation), Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 157 162 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Systolic Blood Pressure 1.11  (1.22) 0.41  (1.23)
Diastolic Blood Pressure -1.1  (0.77) -0.4  (0.78)
29.Secondary Outcome
Title Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.
Hide Description [Not Specified]
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 157 162 0 0 0
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Systolic Blood Pressure -0.74  (1.2) 0.16  (1.21)
Diastolic Blood Pressure -0.66  (0.78) 0.11  (0.79)
30.Secondary Outcome
Title Adverse Events From Run-in (Week -12) to Week 52
Hide Description [Not Specified]
Time Frame Run-in (week -12) to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all exposed subjects
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 159 163 499 166 24
Measure Type: Number
Unit of Measure: events
716 845 2389 383 30
31.Secondary Outcome
Title Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Hide Description Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame weeks 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis.
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 158 163 499 0 0
Measure Type: Number
Unit of Measure: episodes
Major 0 0 0
Minor 2 22 31
Symptoms only 9 19 26
32.Secondary Outcome
Title Hypoglycaemic Episodes Weeks 0-52
Hide Description Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time Frame Week 0-52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description:
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
Overall Number of Participants Analyzed 159 163 499 0 24
Measure Type: Number
Unit of Measure: episodes
Major 0 0 0 0
Minor 4 33 53 1
Symptoms only 14 57 42 2
Unknown 0 1 2 0
Time Frame The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).
Adverse Event Reporting Description The Safety Analysis Set included all exposed subjects
 
Arm/Group Title Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Hide Arm/Group Description Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0% Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0% Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0% Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
All-Cause Mortality
Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/159 (6.92%)      17/163 (10.43%)      62/499 (12.42%)      6/166 (3.61%)      1/24 (4.17%)    
Blood and lymphatic system disorders           
Febrile neutropenia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Thrombocytopenic purpura  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Cardiac disorders           
Angina Pectoris  1  1/159 (0.63%)  1 1/163 (0.61%)  1 1/499 (0.20%)  1 1/166 (0.60%)  1 0/24 (0.00%)  0
Coronary Artery Disease  1  0/159 (0.00%)  0 1/163 (0.61%)  1 4/499 (0.80%)  4 0/166 (0.00%)  0 0/24 (0.00%)  0
Supraventricular Tachycardia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  5 0/166 (0.00%)  0 0/24 (0.00%)  0
Cardiac failure  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Tachycardia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Ear and labyrinth disorders           
Vertigo Positional  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Endocrine disorders           
Goitre  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Thyroid ccell hyperplasia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Eye disorders           
Macular Ischaemia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Macular Oedema  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Gastrointestinal disorders           
Abdominal Pain  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Abdominal Hernia Obstructive  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Intestinal Infarction  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Pancreatitis Chronic  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Food Poisoning  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Abdominal pain upper  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Anal fistula  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Pancreatitis acute  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 1/166 (0.60%)  1 0/24 (0.00%)  0
General disorders           
Chest Pain  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Immune system disorders           
Sarcoidosis  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Infections and infestations           
Clostridium Difficile Colitis  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Helicobacter Gastritis  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Post Procedural Infection  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Viral Infection  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Cellulitis  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Diverticulitis  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Injection site abscess  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Muscle abscess  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Pneumonia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 2/499 (0.40%)  2 0/166 (0.00%)  0 0/24 (0.00%)  0
Injury, poisoning and procedural complications           
Ankle Fracture  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Head Injury  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Joint Injury  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Fall  1  0/159 (0.00%)  0 0/163 (0.00%)  0 2/499 (0.40%)  2 0/166 (0.00%)  0 0/24 (0.00%)  0
Femur Fracture  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Ligament Rupture  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Traumatic Fracture  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Traumatic Intracranial Haemorrhage  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Tendon Rupture  1  0/159 (0.00%)  0 1/163 (0.61%)  1 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Post Lumbar Puncture Syndrome  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Rib Fracture  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Thermal burn  1  0/159 (0.00%)  0 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 1/24 (4.17%)  1
Upper Limb Fracture  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Investigations           
ECG abnormal  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
ECG change  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Metabolism and nutrition disorders           
Hypoglycaemia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 0/499 (0.00%)  0 1/166 (0.60%)  1 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Osteoarthritis  1  1/159 (0.63%)  1 1/163 (0.61%)  1 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Arthritis  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Bursitis  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Interverterbal Disc Degeneration  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  2 0/166 (0.00%)  0 0/24 (0.00%)  0
Interverterbal Disc Protrusion  1  0/159 (0.00%)  0 0/163 (0.00%)  0 2/499 (0.40%)  2 0/166 (0.00%)  0 0/24 (0.00%)  0
Polymyalgia Rheumatica  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Myalgia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 0/499 (0.00%)  0 1/166 (0.60%)  1 0/24 (0.00%)  0
Periarthritis  1  0/159 (0.00%)  0 0/163 (0.00%)  0 2/499 (0.40%)  2 0/166 (0.00%)  0 0/24 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast Cancer  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Metastases to Central Nervous System  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Renal Cancer  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Thyroid Cancer  1  0/159 (0.00%)  0 0/163 (0.00%)  0 0/499 (0.00%)  0 1/166 (0.60%)  1 0/24 (0.00%)  0
Uterine Leiomyoma  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Lung Squamous Cell Carcinoma Unspecified  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
B-Cell Lymphoma  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Fibroadenoma of Breast  1  0/0  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Gallbladder Cancer  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Gastric Cancer  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Metastases to liver  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Prostate Cancer  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders           
Convulsion  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Benign Intracranial Hypertension  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Cerebrovascular Accident  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Syncope  1  0/159 (0.00%)  0 0/163 (0.00%)  0 2/499 (0.40%)  2 0/166 (0.00%)  0 0/24 (0.00%)  0
Transient Ischaemic Attack  1  0/159 (0.00%)  0 0/163 (0.00%)  0 2/499 (0.40%)  2 0/166 (0.00%)  0 0/24 (0.00%)  0
Carotid Artery Stenosis  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Partial Seizures  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Psychiatric disorders           
Depression  1  0/159 (0.00%)  0 2/163 (1.23%)  2 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Anxiety  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Renal and urinary disorders           
Nephrolithiasis  1  0/159 (0.00%)  0 1/163 (0.61%)  1 1/499 (0.20%)  1 1/166 (0.60%)  1 0/24 (0.00%)  0
Urinary Retention  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Renal Colic  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Renal Failure  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Renal failure acute  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Reproductive system and breast disorders           
Cystocele  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Benign prostatic hyperplasia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Breast hyperplasia  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Erectile Dysfunction  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Fibrocystic Breast Disease  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Vaginal Haemorrhage  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Bronchopulmonary Disease  1  0/159 (0.00%)  0 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Nasal Septum Deviation  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Epistaxis  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Pulmonary Mass  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders           
Eczema  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Skin ulcer  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  1 0/166 (0.00%)  0 0/24 (0.00%)  0
Surgical and medical procedures           
Medical device removal  1  1/159 (0.63%)  1 0/163 (0.00%)  0 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Vascular disorders           
Peripheral Arterial Occlusive Disease  1  1/159 (0.63%)  1 1/163 (0.61%)  1 0/499 (0.00%)  0 0/166 (0.00%)  0 0/24 (0.00%)  0
Poor Peripheral Circulation  1  0/159 (0.00%)  0 0/163 (0.00%)  0 1/499 (0.20%)  2 0/166 (0.00%)  0 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lira 1.8 Insulin Detemir + Lira 1.8 Non-Randomised Lira 1.8 Early Withdrawals Lira 1.8 Intensified Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   100/159 (62.89%)      102/163 (62.58%)      310/499 (62.12%)      122/166 (73.49%)      11/24 (45.83%)    
Gastrointestinal disorders           
Diarrhoea  1  26/159 (16.35%)  29 29/163 (17.79%)  42 74/499 (14.83%)  108 21/166 (12.65%)  25 1/24 (4.17%)  1
Nausea  1  37/159 (23.27%)  51 30/163 (18.40%)  40 136/499 (27.25%)  204 66/166 (39.76%)  72 1/24 (4.17%)  1
Vomiting  1  19/159 (11.95%)  21 17/163 (10.43%)  26 50/499 (10.02%)  113 21/166 (12.65%)  25 0/24 (0.00%)  0
Dyspepsia  1  8/159 (5.03%)  11 10/163 (6.13%)  11 42/499 (8.42%)  54 33/166 (19.88%)  42 0/24 (0.00%)  0
Constipation  1  11/159 (6.92%)  11 8/163 (4.91%)  10 25/499 (5.01%)  30 11/166 (6.63%)  11 0/24 (0.00%)  0
Abdominal Pain  1  8/159 (5.03%)  11 6/163 (3.68%)  7 14/499 (2.81%)  17 5/166 (3.01%)  6 0/24 (0.00%)  0
General disorders           
Fatigue  1  9/159 (5.66%)  10 12/163 (7.36%)  13 15/499 (3.01%)  16 6/166 (3.61%)  8 0/24 (0.00%)  0
Infections and infestations           
Nasopharyngitis  1  40/159 (25.16%)  57 33/163 (20.25%)  45 72/499 (14.43%)  97 2/166 (1.20%)  2 3/24 (12.50%)  3
Upper respiratory tract infection  1  9/159 (5.66%)  14 13/163 (7.98%)  13 21/499 (4.21%)  24 0/166 (0.00%)  0 0/24 (0.00%)  0
Investigations           
Lipase Increased  1  16/159 (10.06%)  17 26/163 (15.95%)  27 55/499 (11.02%)  60 6/166 (3.61%)  7 4/24 (16.67%)  4
Metabolism and nutrition disorders           
Decreased Appetite  1  9/159 (5.66%)  9 13/163 (7.98%)  13 50/499 (10.02%)  53 17/166 (10.24%)  17 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back Pain  1  10/159 (6.29%)  10 4/163 (2.45%)  6 26/499 (5.21%)  30 4/166 (2.41%)  5 1/24 (4.17%)  1
Nervous system disorders           
Headache  1  23/159 (14.47%)  41 21/163 (12.88%)  54 73/499 (14.63%)  144 13/166 (7.83%)  22 2/24 (8.33%)  2
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal Pain  1  10/159 (6.29%)  11 5/163 (3.07%)  5 17/499 (3.41%)  19 2/166 (1.20%)  2 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Novo Nordisk reserves the right not to release data until specified milestones, e.g. a clinical trial report is available. This includes the right not to release interim results from clinical trials.

At the end of the trial, one or more manuscripts for publication will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk will not suppress or veto publications. Novo Nordisk reserves the right to postpone publication for a short time to protect intellectual property.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00856986     History of Changes
Other Study ID Numbers: NN2211-1842
2007-005317-19 ( EudraCT Number )
First Submitted: March 5, 2009
First Posted: March 6, 2009
Results First Submitted: April 19, 2011
Results First Posted: May 13, 2011
Last Update Posted: March 8, 2017