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To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c (LEAD-3)

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ClinicalTrials.gov Identifier: NCT00294723
Recruitment Status : Terminated (The trial was terminated at week 195 due to an insufficient number of subjects remaining to obtain reasonable statistical power)
First Posted : February 22, 2006
Results First Posted : March 12, 2010
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: liraglutide
Drug: glimepiride
Drug: placebo
Enrollment 746
Recruitment Details A total of 138 centres in two countries: United States of America (USA) (126) and Mexico (12).
Pre-assignment Details Subjects with type 2 diabetes treated with diet/exercise or OAD (Oral Anti-Diabetic Drug) monotherapy for at least 2 months were eligible. One subject randomised to the liraglutide 1.8 mg group was withdrawn from the study prior to dosing due to protocol non compliance, subject was not included in the intent-to-treat (ITT) or safety analysis sets.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195) Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195) Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Period Title: Double-Blind Period 52 Weeks
Started 247 [1] 251 [1] 248 [1]
Exposed to Study Drug 246 [2] 251 248
Completed 173 162 152
Not Completed 74 89 96
Reason Not Completed
Adverse Event             18             25             15
Lack of Efficacy             9             15             25
Protocol Violation             11             11             5
Not specified in study report             36             38             51
[1]
Randomised
[2]
Subject withdrew before exposure to drug, and thus not included in the safety and ITT analysis sets
Period Title: Open-Label Extension 52 Weeks
Started 154 [1] 149 [2] 137 [3]
Completed 114 110 97
Not Completed 40 39 40
Reason Not Completed
Adverse Event             5             5             2
Lack of Efficacy             12             15             21
Protocol Violation             4             3             3
Not specified in study report             19             16             14
[1]
19 subjects did not continue into the extension period
[2]
13 subjects did not continue into the extension period
[3]
15 subjects did not continue into the extension period
Period Title: Additional Open-Label Extension 91 Weeks
Started 62 [1] 53 [2] 28 [3]
Completed 34 32 8
Not Completed 28 21 20
Reason Not Completed
Adverse Event             1             1             0
Lack of Efficacy             24             14             16
Protocol Violation             1             1             1
Not specified in study report             2             5             3
[1]
52 subjects did not continue into the extension period
[2]
57 subjects did not continue into the extension period
[3]
69 subjects did not continue into the extension period
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride Total
Hide Arm/Group Description Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195) Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195) Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195) Total of all reporting groups
Overall Number of Baseline Participants 247 251 248 746
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 248 participants 746 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
222
  89.9%
208
  82.9%
208
  83.9%
638
  85.5%
>=65 years
25
  10.1%
43
  17.1%
40
  16.1%
108
  14.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 247 participants 251 participants 248 participants 746 participants
52.0  (10.8) 53.7  (11.0) 53.4  (10.9) 53.0  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 248 participants 746 participants
Female
126
  51.0%
134
  53.4%
115
  46.4%
375
  50.3%
Male
121
  49.0%
117
  46.6%
133
  53.6%
371
  49.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 248 participants 746 participants
Hispanic or Latino
87
  35.2%
81
  32.3%
93
  37.5%
261
  35.0%
Not Hispanic or Latino
160
  64.8%
170
  67.7%
155
  62.5%
485
  65.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 248 participants 746 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
12
   4.9%
5
   2.0%
9
   3.6%
26
   3.5%
Native Hawaiian or Other Pacific Islander
2
   0.8%
0
   0.0%
0
   0.0%
2
   0.3%
Black or African American
30
  12.1%
34
  13.5%
30
  12.1%
94
  12.6%
White
186
  75.3%
200
  79.7%
192
  77.4%
578
  77.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
17
   6.9%
12
   4.8%
17
   6.9%
46
   6.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 248 participants 746 participants
Mexico 52 53 66 171
United States 195 198 182 575
Previous anti-diabetic treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 247 participants 251 participants 248 participants 746 participants
Diet/Exercise 87 91 94 272
Monotherapy 160 160 154 474
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 247 participants 251 participants 248 participants 746 participants
32.8  (6.3) 33.2  (5.6) 33.2  (5.6) 33.1  (5.8)
Duration of diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 247 participants 251 participants 248 participants 746 participants
5.3  (5.1) 5.2  (5.5) 5.6  (5.1) 5.4  (5.3)
[1]
Measure Description: Number of years since diagnosis
HbA1c (Glycosylated Haemoglobin A1c)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of total haemoglobin
Number Analyzed 247 participants 251 participants 248 participants 746 participants
8.3  (1.1) 8.3  (1.0) 8.4  (1.2) 8.3  (1.1)
[1]
Measure Description: HbA1c at screening
1.Primary Outcome
Title Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Hide Description Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)
Time Frame week 0, week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 234 236 241
Least Squares Mean (Standard Error)
Unit of Measure: percentage point of total HbA1c
-1.14  (0.08) -0.84  (0.08) -0.51  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The two sided 95% confidence interval for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.
Statistical Test of Hypothesis P-Value <0.0001
Comments

The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.

2-sided significance level 5%

Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.62
Confidence Interval 95%
-0.83 to -0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The two sided 95% confidence interval for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.
Statistical Test of Hypothesis P-Value 0.0014
Comments

The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.

2-sided significance level 5%

Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.33
Confidence Interval 95%
-0.53 to -0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg – liraglutide 1.2 mg) was below 0%.
Statistical Test of Hypothesis P-Value 0.0046
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.29
Confidence Interval 95%
-0.50 to -0.09
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104
Hide Description Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)
Time Frame week 0, week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 234 236 241
Least Squares Mean (Standard Error)
Unit of Measure: percentage point of total HbA1c
-0.88  (0.09) -0.59  (0.09) -0.28  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The two sided 95% confidence interval for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.
Statistical Test of Hypothesis P-Value <.0001
Comments

The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.

2-sided significance level 5%

Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.60
Confidence Interval 95%
-0.83 to -0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The two sided 95% CI for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.
Statistical Test of Hypothesis P-Value 0.0076
Comments

The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.

2-sided significance level 5%

Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.31
Confidence Interval 95%
-0.54 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg – liraglutide 1.2 mg) was below 0%.
Statistical Test of Hypothesis P-Value 0.0129
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.29
Confidence Interval 95%
-0.52 to -0.06
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156
Hide Description Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks
Time Frame week 0, week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 234 236 241
Least Squares Mean (Standard Error)
Unit of Measure: percentage point of total HbA1c
-0.71  (0.09) -0.44  (0.09) -0.16  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The two-sided 95% confidence interval (CI) for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%.
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.55
Confidence Interval 95%
-0.77 to -0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The two-sided 95% confidence interval (CI) for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.
Statistical Test of Hypothesis P-Value 0.0122
Comments The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.28
Confidence Interval 95%
-0.49 to -0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.
Statistical Test of Hypothesis P-Value 0.0123
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.28
Confidence Interval 95%
-0.49 to -0.06
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Body Weight at Week 52
Hide Description Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)
Time Frame week 0, week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 240 245 248
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.45  (0.28) -2.05  (0.28) 1.12  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value <.0001
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -3.58
Confidence Interval 95%
-4.28 to -2.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value <.0001
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -3.17
Confidence Interval 95%
-3.87 to -2.47
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.2584
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.41
Confidence Interval 95%
-1.11 to 0.30
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Body Weight at Week 104
Hide Description Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)
Time Frame week 0, week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 240 245 248
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.70  (0.32) -1.89  (0.31) 0.95  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value <.0001
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -3.65
Confidence Interval 95%
-4.44 to -2.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value <.0001
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -2.84
Confidence Interval 95%
-3.63 to -2.06
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.0462
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.80
Confidence Interval 95%
-1.59 to -0.01
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Body Weight at Week 156
Hide Description Change in body weight from baseline (week 0) to 156 weeks
Time Frame week 0, week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 240 245 248
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.43  (0.32) -1.68  (0.32) 1.05  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value <0.0001
Comments 2-sided significance level was 5%.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -3.48
Confidence Interval 95%
-4.28 to -2.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value <0.0001
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -2.72
Confidence Interval 95%
-3.52 to -1.93
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariance.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.0642
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.75
Confidence Interval 95%
-1.55 to 0.05
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Fasting Plasma Glucose at Week 52
Hide Description Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)
Time Frame week 0, week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 230 234 242
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-25.57  (3.50) -15.21  (3.50) -5.29  (3.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value <.0001
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -20.28
Confidence Interval 95%
-29.09 to -11.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.0270
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -9.92
Confidence Interval 95%
-18.70 to -1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.0223
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -10.36
Confidence Interval 95%
-19.24 to -1.48
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Fasting Plasma Glucose at Week 104
Hide Description Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)
Time Frame week 0, week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 230 234 242
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-15.82  (3.85) -9.36  (3.85) 1.97  (3.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.0003
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -17.79
Confidence Interval 95%
-27.48 to -8.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.0217
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -11.33
Confidence Interval 95%
-20.99 to -1.66
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg
Statistical Test of Hypothesis P-Value 0.1942
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -6.46
Confidence Interval 95%
-16.23 to 3.30
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Fasting Plasma Glucose at Week 156
Hide Description Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks
Time Frame week 0, week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 230 234 242
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-12.06  (3.8) -5.45  (3.8) 4.57  (3.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.0007
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -16.63
Confidence Interval 95%
-26.19 to -7.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.0395
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -10.02
Confidence Interval 95%
-19.56 to -0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.1789
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -6.60
Confidence Interval 95%
-16.24 to 3.03
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Hide Description Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Time Frame week 0, week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 191 187 182
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-37.4  (3.37) -30.8  (3.40) -24.5  (3.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in mean postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.0038
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -12.9
Confidence Interval 95%
-21.6 to -4.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.1616
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -6.3
Confidence Interval 95%
-15.0 to 2.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.1319
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -6.6
Confidence Interval 95%
-15.3 to 2.0
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Hide Description Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Time Frame week 0, week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 191 187 183
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-37.15  (3.64) -27.34  (3.68) -24.85  (3.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.0105
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -12.30
Confidence Interval 95%
-21.71 to -2.89
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.6060
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -2.49
Confidence Interval 95%
-11.95 to 6.98
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.0392
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -9.81
Confidence Interval 95%
-19.14 to -0.49
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Hide Description Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Time Frame week 0, week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 191 187 183
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-34.83  (3.65) -25.68  (3.69) -23.84  (3.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.0227
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -10.98
Confidence Interval 95%
-20.42 to -1.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.7047
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -1.83
Confidence Interval 95%
-11.33 to 7.66
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.0553
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -9.15
Confidence Interval 95%
-18.51 to 0.21
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Hide Description Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
Time Frame week 0, week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 191 187 182
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-9.6  (2.07) -8.4  (2.10) -5.6  (2.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.1396
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -4.0
Confidence Interval 95%
-9.4 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.2968
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -2.9
Confidence Interval 95%
-8.3 to 2.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in postprandial (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.6639
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -1.2
Confidence Interval 95%
-6.5 to 4.1
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Hide Description Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
Time Frame week 0, week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 191 187 183
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-11.76  (2.11) -8.28  (2.14) -7.95  (2.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.1720
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -3.81
Confidence Interval 95%
-9.28 to 1.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.9060
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.33
Confidence Interval 95%
-5.82 to 5.16
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.2089
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -3.48
Confidence Interval 95%
-8.91 to 1.95
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Hide Description Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
Time Frame week 0, week 156
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 191 187 183
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-11.01  (2.11) -7.53  (2.14) -7.97  (2.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Glimepiride
Comments Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.2749
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -3.04
Confidence Interval 95%
-8.51 to 2.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lira 1.2, Glimepiride
Comments Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
Statistical Test of Hypothesis P-Value 0.8765
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 0.43
Confidence Interval 95%
-5.05 to 5.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lira 1.8, Lira 1.2
Comments Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Statistical Test of Hypothesis P-Value 0.2088
Comments 2-sided significance level 5%
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -3.48
Confidence Interval 95%
-8.90 to 1.95
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Hypoglycaemic Episodes
Hide Description Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
Time Frame weeks 0-104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full safety analysis set is all subjects who had been exposed to at least one dose of the study products.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 246 251 248
Measure Type: Number
Unit of Measure: episodes
Major 1 0 0
Minor 71 68 533
Symptoms only 87 133 405
17.Secondary Outcome
Title Hypoglycaemic Episodes
Hide Description Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
Time Frame weeks 104-195
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set is all subjects who entered the year 3 extension at week 104.
Arm/Group Title Lira 1.8 Lira 1.2 Glimepiride
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Overall Number of Participants Analyzed 62 53 28
Measure Type: Number
Unit of Measure: episodes
Major 0 0 1
Minor 13 3 34
Symptoms only 3 1 4
Time Frame The adverse events were collected in a time span of 195 weeks.
Adverse Event Reporting Description The full safety analysis set is all subjects who had been exposed to at least one dose of the study products.
 
Arm/Group Title Lira 1.8 (Weeks 0-104) Lira 1.2 (Weeks 0-104) Glimepiride (Weeks 0-104) Lira 1.8 (Weeks 104-195) Lira 1.2 (Weeks 104-195) Glimepiride (Weeks 104-195)
Hide Arm/Group Description Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension period (weeks 52-104) Liraglutide 1.2 mg once daily + glimepiride placebo 8mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension period (weeks 52-104) Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension period (weeks 52-104) Open-label liraglutide 1.8 mg once daily in the additional extension period (weeks 104-195) Open-label liraglutide 1.2 mg once daily in the additional extension period (weeks 104-195) Open-label glimepiride 8 mg once daily in the additional extension period (weeks 104-195)
All-Cause Mortality
Lira 1.8 (Weeks 0-104) Lira 1.2 (Weeks 0-104) Glimepiride (Weeks 0-104) Lira 1.8 (Weeks 104-195) Lira 1.2 (Weeks 104-195) Glimepiride (Weeks 104-195)
Affected / at Risk (%) 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 (Weeks 0-104) Lira 1.2 (Weeks 0-104) Glimepiride (Weeks 0-104) Lira 1.8 (Weeks 104-195) Lira 1.2 (Weeks 104-195) Glimepiride (Weeks 104-195)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/246 (8.94%)      23/251 (9.16%)      20/248 (8.06%)      5/62 (8.06%)      1/53 (1.89%)      2/28 (7.14%)    
Blood and lymphatic system disorders             
Anaemia  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Cardiac disorders             
Acute Myocardial Infarction  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Angina Pectoris  1  1/246 (0.41%)  1 0/251 (0.00%)  0 2/248 (0.81%)  2 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Angina Unstable  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 1/28 (3.57%)  1
Atrial Fibrillation  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Cardiac Failure Congestive  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Coronary Artery Disease  1  0/246 (0.00%)  0 1/251 (0.40%)  1 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Ischaemic Cardiomyopathy  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Myocardial Infarction  1  2/246 (0.81%)  2 1/251 (0.40%)  1 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Myocardial Ischaemia  1  0/246 (0.00%)  0 0/251 (0.00%)  0 2/248 (0.81%)  2 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Supraventricular Tachycardia  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Tachycardia  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Endocrine disorders             
Adrenocortical Insufficiency Acute  1  0/246 (0.00%)  0 2/251 (0.80%)  2 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Thyroid Disorder  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Eye disorders             
Retinal Detachment  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 1/62 (1.61%)  1 0/53 (0.00%)  0 0/28 (0.00%)  0
Vision Blurred  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Gastrointestinal disorders             
Appendicitis Perforated  1  1/246 (0.41%)  1 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Crohn's Disease  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Diarrhoea  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Diverticulum Oesophageal  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Gastrointestinal Haemorrhage  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Haemorrhoids  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Ileus  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Intestinal Obstruction  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Oedematous Pancreatitis  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Pancreatitis  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Pancreatitis Acute  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
General disorders             
Chest Pain  1  0/246 (0.00%)  0 1/251 (0.40%)  1 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Hepatobiliary disorders             
Cholecystitis  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Cholelithiasis  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Hepatic cirrhosis  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 1/62 (1.61%)  1 0/53 (0.00%)  0 0/28 (0.00%)  0
Hepatic failure  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 1/62 (1.61%)  1 0/53 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations             
Abscess Limb  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Cellulitis  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Clostridial Infection  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Fungaemia  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Gastroenteritis  1  1/246 (0.41%)  1 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Upper Respiratory Tract Infection  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Urinary Tract Infection  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Viral Infection  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Gastroenteritis viral  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 1/28 (3.57%)  1
Injury, poisoning and procedural complications             
Hand Fracture  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Lower Limb Fracture  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Road Traffic Accident  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Skin Laceration  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Tendon Injury  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Traumatic Coma  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Upper Limb Fracture  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Metabolism and nutrition disorders             
Dehydration  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Hypoglycaemia  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 1/28 (3.57%)  1
Hypokalaemia  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Hyponatraemia  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Diabetic ketoacidosis  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 1/62 (1.61%)  1 0/53 (0.00%)  0 0/28 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back Pain  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Intervertebral Disc Degeneration  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Lumbar Spinal Stenosis  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Muscle Spasms  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Musculoskeletal chest pain  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 1/62 (1.61%)  1 0/53 (0.00%)  0 0/28 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Benign Neoplasm Of Thyroid Gland  1  1/246 (0.41%)  1 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Breast Cancer  1  2/246 (0.81%)  2 1/251 (0.40%)  1 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Colon Cancer  1  1/246 (0.41%)  1 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Colon Cancer Stage 0  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Nasopharyngeal Cancer  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Prostate Cancer  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Thyroid Cancer  1  1/246 (0.41%)  1 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Thyroid Neoplasm  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Nervous system disorders             
Epilepsy  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Grand Mal Convulsion  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Hypoaesthesia  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Nerve Compression  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Radial Nerve Palsy  1  0/246 (0.00%)  0 1/251 (0.40%)  1 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Cervical myelopathy  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 1/62 (1.61%)  1 0/53 (0.00%)  0 0/28 (0.00%)  0
Hepatic encephalopathy  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 1/62 (1.61%)  1 0/53 (0.00%)  0 0/28 (0.00%)  0
Psychiatric disorders             
Suicidal Ideation  1  0/246 (0.00%)  0 1/251 (0.40%)  2 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Panic attack  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 1/53 (1.89%)  1 0/28 (0.00%)  0
Renal and urinary disorders             
Hydronephrosis  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Nephrolithiasis  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Urethral Stenosis  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Reproductive system and breast disorders             
Pelvic haematoma  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 1/62 (1.61%)  1 0/53 (0.00%)  0 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Bronchitis Chronic  1  0/246 (0.00%)  0 0/251 (0.00%)  0 1/248 (0.40%)  1 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Pulmonary Embolism  1  1/246 (0.41%)  1 0/251 (0.00%)  0 0/248 (0.00%)  0 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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 (Weeks 0-104) Lira 1.2 (Weeks 0-104) Glimepiride (Weeks 0-104) Lira 1.8 (Weeks 104-195) Lira 1.2 (Weeks 104-195) Glimepiride (Weeks 104-195)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   183/246 (74.39%)      181/251 (72.11%)      148/248 (59.68%)      40/62 (64.52%)      37/53 (69.81%)      13/28 (46.43%)    
Gastrointestinal disorders             
Nausea  1  75/246 (30.49%)  117 72/251 (28.69%)  97 21/248 (8.47%)  31 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Diarrhoea  1  48/246 (19.51%)  66 44/251 (17.53%)  75 23/248 (9.27%)  37 5/62 (8.06%)  9 3/53 (5.66%)  3 1/28 (3.57%)  1
Vomiting  1  25/246 (10.16%)  36 33/251 (13.15%)  38 10/248 (4.03%)  12 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Constipation  1  29/246 (11.79%)  35 21/251 (8.37%)  24 12/248 (4.84%)  12 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Flatulence  1  13/246 (5.28%)  14 4/251 (1.59%)  4 5/248 (2.02%)  5 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Gastritis  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 3/62 (4.84%)  4 2/53 (3.77%)  2 2/28 (7.14%)  3
General disorders             
Fatigue  1  13/246 (5.28%)  15 8/251 (3.19%)  9 9/248 (3.63%)  10 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Infections and infestations             
Upper respiratory tract infection  1  32/246 (13.01%)  42 36/251 (14.34%)  48 22/248 (8.87%)  30 8/62 (12.90%)  9 8/53 (15.09%)  10 1/28 (3.57%)  1
Influenza  1  27/246 (10.98%)  37 23/251 (9.16%)  35 21/248 (8.47%)  27 3/62 (4.84%)  4 5/53 (9.43%)  8 2/28 (7.14%)  2
Sinusitis  1  18/246 (7.32%)  31 21/251 (8.37%)  25 18/248 (7.26%)  24 4/62 (6.45%)  4 1/53 (1.89%)  3 0/28 (0.00%)  0
Urinary tract infection  1  14/246 (5.69%)  18 26/251 (10.36%)  35 13/248 (5.24%)  15 6/62 (9.68%)  8 4/53 (7.55%)  4 0/28 (0.00%)  0
Nasopharyngitis  1  16/246 (6.50%)  21 23/251 (9.16%)  26 18/248 (7.26%)  19 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Bronchitis  1  9/246 (3.66%)  12 15/251 (5.98%)  17 11/248 (4.44%)  14 4/62 (6.45%)  4 2/53 (3.77%)  2 0/28 (0.00%)  0
Pharyngitis  1  0/246 (0.00%)  0 0/251 (0.00%)  0 0/248 (0.00%)  0 4/62 (6.45%)  7 2/53 (3.77%)  4 1/28 (3.57%)  1
Musculoskeletal and connective tissue disorders             
Back pain  1  17/246 (6.91%)  18 18/251 (7.17%)  21 17/248 (6.85%)  17 3/62 (4.84%)  3 4/53 (7.55%)  4 1/28 (3.57%)  1
Arthralgia  1  6/246 (2.44%)  6 11/251 (4.38%)  14 15/248 (6.05%)  15 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Pain in extremity  1  15/246 (6.10%)  15 9/251 (3.59%)  10 8/248 (3.23%)  9 1/62 (1.61%)  1 3/53 (5.66%)  3 0/28 (0.00%)  0
Nervous system disorders             
Headache  1  18/246 (7.32%)  26 28/251 (11.16%)  53 23/248 (9.27%)  30 1/62 (1.61%)  2 2/53 (3.77%)  2 3/28 (10.71%)  3
Dizziness  1  19/246 (7.72%)  21 13/251 (5.18%)  19 13/248 (5.24%)  14 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Psychiatric disorders             
Depression  1  14/246 (5.69%)  14 8/251 (3.19%)  11 5/248 (2.02%)  5 0/62 (0.00%)  0 0/53 (0.00%)  0 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  14/246 (5.69%)  16 5/251 (1.99%)  6 11/248 (4.44%)  13 2/62 (3.23%)  2 3/53 (5.66%)  3 0/28 (0.00%)  0
Vascular disorders             
Hypertension  1  11/246 (4.47%)  11 14/251 (5.58%)  14 17/248 (6.85%)  19 2/62 (3.23%)  2 6/53 (11.32%)  6 2/28 (7.14%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Trial terminated due to an insufficient number of subjects remaining to obtain reasonable statistical power. Efficacy data was not analysed after week 156. Safety data was collected through week 195. No data was available from week 195 to 260
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 to not release data until specified milestones. This includes the right to not release interim results, because the release of such information can invalidate the results of the entire trial. At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
Results Point of Contact
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00294723     History of Changes
Obsolete Identifiers: NCT00853359
Other Study ID Numbers: NN2211-1573
First Submitted: February 20, 2006
First Posted: February 22, 2006
Results First Submitted: February 23, 2010
Results First Posted: March 12, 2010
Last Update Posted: March 7, 2017