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Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-6)

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ClinicalTrials.gov Identifier: NCT00518882
Recruitment Status : Completed
First Posted : August 21, 2007
Results First Posted : March 23, 2010
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: liraglutide
Drug: exenatide
Enrollment 467
Recruitment Details A total of 133 centres in 15 countries: Austria (4), Denmark (6), Finland (5), France (5), Germany (14), Ireland (4), Macedonia (1), Norway (4), Poland (9), Romania (3), Slovenia (3), Spain (4), Sweden (2), Switzerland (4) and United States (65).
Pre-assignment Details Eligible subjects were subjects with type 2 diabetes being treated with oral anti-diabetic (OAD) therapy(ies) for at least 3 months prior to the study. Three subjects were exposed to study drug prior to randomisation, and thus only included in safety analysis set.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Period Title: Double-Blind, Week 0-26
Started 235 [1] 232 [2]
Randomised 233 231
Completed 202 187
Not Completed 33 45
Reason Not Completed
Adverse Event             23             31
Lack of Efficacy             1             0
Protocol Violation             4             3
Withdrawal criteria             1             1
Lost to follow up             2             1
Subject decision             1             1
Withdrawal of consent             1             3
Loss of trust             0             1
Fear of hypoglycaemia             0             1
Hypoglycaemia             0             2
Mutual consent             0             1
[1]
2 subjects exposed to study drug before randomisation. Subjects only included in safety analysis set
[2]
1 subject exposed to study drug before randomisation. Subject only included in safety analysis set
Period Title: Open-Label Extension, Week 26-78
Started 202 187
Completed 161 138
Not Completed 41 49
Reason Not Completed
Adverse Event             3             9
Lack of Efficacy             6             5
Protocol Violation             3             4
Withdrawel criteria             1             2
Hypoglycaemia             0             1
Lost to follow up             1             1
Consent withdrawn             2             1
Change in treatment             1             1
Creatine increased             1             0
Decreased kidney function             1             0
Exclusion criteria             2             0
Subject decision             2             0
Completed extension 1 (weeks 26-40)             18             25
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide Total
Hide Arm/Group Description Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) Total of all reporting groups
Overall Number of Baseline Participants 233 231 464
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 233 participants 231 participants 464 participants
56.3  (9.8) 57.1  (10.8) 56.7  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants 231 participants 464 participants
Female
119
  51.1%
104
  45.0%
223
  48.1%
Male
114
  48.9%
127
  55.0%
241
  51.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants 231 participants 464 participants
Hispanic or Latino
32
  13.7%
25
  10.8%
57
  12.3%
Not Hispanic or Latino
201
  86.3%
206
  89.2%
407
  87.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants 231 participants 464 participants
American Indian or Alaska Native
0
   0.0%
1
   0.4%
1
   0.2%
Asian
0
   0.0%
4
   1.7%
4
   0.9%
Native Hawaiian or Other Pacific Islander
1
   0.4%
1
   0.4%
2
   0.4%
Black or African American
13
   5.6%
12
   5.2%
25
   5.4%
White
216
  92.7%
210
  90.9%
426
  91.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   1.3%
3
   1.3%
6
   1.3%
Previous OAD treatment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 233 participants 231 participants 464 participants
Metformin/Sulphonylurea Combination 145 147 292
Sulphonylurea 24 21 45
Metformin 64 63 127
[1]
Measure Description: OAD = Oral Anti-diabetic Drug
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 233 participants 231 participants 464 participants
32.9  (5.5) 32.9  (5.7) 32.9  (5.6)
[1]
Measure Description: Body Mass Index
Duration of diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 233 participants 231 participants 464 participants
8.5  (6.2) 7.9  (5.9) 8.2  (6.0)
[1]
Measure Description: Number of years since diagnosis
HbA1c   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of total haemoglobin
Number Analyzed 233 participants 231 participants 464 participants
8.4  (1.0) 8.2  (1.0) 8.3  (1.0)
[1]
Measure Description: Glycosylated Haemoglobin at screening
Height  
Mean (Standard Deviation)
Unit of measure:  m
Number Analyzed 233 participants 231 participants 464 participants
1.68  (0.10) 1.68  (0.10) 1.68  (0.10)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 233 participants 231 participants 464 participants
93.1  (20.1) 93.0  (19.5) 93.1  (19.8)
1.Primary Outcome
Title Change in Glycosylated A1c (HbA1c) at Week 26
Hide Description Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 227 226
Least Squares Mean (Standard Error)
Unit of Measure: percentage point of total HbA1c
-1.12  (0.08) -0.79  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments

ANCOVA with treatment, country and previous OAD treatment as fixed effects and baseline HbA1c as covariate.

2 hypotheses were tested: H01: µliraglutide ≥ µexenatide + Δ, HA1: µliraglutide < µexenatide + Δ; Δ=0.4%. If non-inferiority was concluded, a test for superiority was established by a 1-sided test of the hypothesis H02: µliraglutide ≥ µexenatide against HA2: µliraglutide < µexenatide. Superiority was concluded if the upper limit of the 2-sided 95% CI for the difference was below 0%.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority concluded if upper confidence interval of test is below 0.4%
Statistical Test of Hypothesis P-Value <.0001
Comments No multiplicity concerns
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.33
Confidence Interval 95%
-0.47 to -0.18
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Glycosylated A1c (HbA1c), Weeks 26-78
Hide Description Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 198 183
Mean (Standard Deviation)
Unit of Measure: percentage point of total HbA1c
0.25  (0.803) -0.00  (0.924)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.25
Confidence Interval 95%
0.139 to 0.364
Parameter Dispersion
Type: Standard Deviation
Value: 0.803
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9872
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.00
Confidence Interval 95%
-1.36 to 0.134
Parameter Dispersion
Type: Standard Deviation
Value: 0.924
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Glycosylated A1c (HbA1c) at Week 78
Hide Description Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 198 183
Mean (Standard Deviation)
Unit of Measure: percentage point of total HbA1c
-0.98  (1.119) -0.85  (1.105)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 – µ0 = 0 against HA: µ78 – µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.98
Confidence Interval 95%
-1.137 to -0.823
Parameter Dispersion
Type: Standard Deviation
Value: 1.119
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the exenatide→liraglutide group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 – µ0 = 0 against HA: µ78 – µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.85
Confidence Interval 95%
-1.010 to -0.687
Parameter Dispersion
Type: Standard Deviation
Value: 1.105
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26
Hide Description Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 233 231
Measure Type: Number
Unit of Measure: percentage (%) of subjects
Treatment target HbA1c < 7% 53 42
Treatment target HbA1c =< 6.5% 34 20
5.Secondary Outcome
Title Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78
Hide Description Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 200 186
Measure Type: Number
Unit of Measure: percentage (%) of subjects
Treatment target HbA1c < 7% 47 48
Treatment target HbA1c =< 6.5% 31 35
6.Secondary Outcome
Title Change in Body Weight at Week 26
Hide Description Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 231 229
Least Squares Mean (Standard Error)
Unit of Measure: kg
-3.24  (0.33) -2.87  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline body weight as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the body weight in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2235
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.38
Confidence Interval 95%
-0.99 to 0.23
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Body Weight, Weeks 26-78
Hide Description Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 199 184
Mean (Standard Deviation)
Unit of Measure: kg
-0.4  (3.24) -0.7  (3.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26=0 against HA: µ78 – µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0793
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.4
Confidence Interval 95%
-0.86 to 0.05
Parameter Dispersion
Type: Standard Deviation
Value: 3.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.7
Confidence Interval 95%
-1.26 to -0.20
Parameter Dispersion
Type: Standard Deviation
Value: 3.67
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Body Weight at Week 78
Hide Description Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 199 184
Mean (Standard Deviation)
Unit of Measure: kg
-3.3  (4.63) -3.2  (4.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -3.3
Confidence Interval 95%
-3.90 to -2.61
Parameter Dispersion
Type: Standard Deviation
Value: 4.63
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -3.2
Confidence Interval 95%
-3.85 to -2.55
Parameter Dispersion
Type: Standard Deviation
Value: 4.44
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Fasting Plasma Glucose at Week 26
Hide Description Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 225 219
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.61  (0.20) -0.60  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline fasting plasma glucose as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the fasting plasma glucose in the liraglutide and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -1.01
Confidence Interval 95%
-1.37 to -0.65
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in Fasting Plasma Glucose, Weeks 26-78
Hide Description Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 197 182
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.7  (1.84) -0.1  (2.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78– µ26=0 against HA: µ78 – µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.7
Confidence Interval 95%
0.48 to 1.00
Parameter Dispersion
Type: Standard Deviation
Value: 1.84
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4864
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.1
Confidence Interval 95%
-0.48 to 0.23
Parameter Dispersion
Type: Standard Deviation
Value: 2.42
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Fasting Plasma Glucose at Week 78
Hide Description Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group)
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 197 182
Mean (Standard Deviation)
Unit of Measure: mmol/L
-1.3  (2.50) -0.8  (2.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 – µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -1.3
Confidence Interval 95%
-1.62 to -0.92
Parameter Dispersion
Type: Standard Deviation
Value: 2.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 – µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.8
Confidence Interval 95%
-1.23 to -0.42
Parameter Dispersion
Type: Standard Deviation
Value: 2.76
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26
Hide Description Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 207 196
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.83  (0.28) -2.16  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 1.33
Confidence Interval 95%
0.80 to 1.86
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26
Hide Description Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 207 196
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.06  (0.28) 0.06  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9849
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 0.01
Confidence Interval 95%
-0.52 to 0.53
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26
Hide Description Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 204 196
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.10  (0.31) -2.11  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value 1.01
Confidence Interval 95%
0.44 to 1.57
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Hide Description Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 191 173
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.22  (2.866) 1.15  (3.253)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2972
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.22
Confidence Interval 95%
-0.626 to 0.192
Parameter Dispersion
Type: Standard Deviation
Value: 2.866
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 1.15
Confidence Interval 95%
0.660 to 1.637
Parameter Dispersion
Type: Standard Deviation
Value: 3.253
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Hide Description Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 191 173
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.05  (3.307) -0.09  (3.419)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8396
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.05
Confidence Interval 95%
-0.424 to 0.521
Parameter Dispersion
Type: Standard Deviation
Value: 3.307
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7278
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.09
Confidence Interval 95%
-0.604 to 0.423
Parameter Dispersion
Type: Standard Deviation
Value: 3.419
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Hide Description Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 190 172
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.22  (3.053) 1.07  (3.775)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3271
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.22
Confidence Interval 95%
-0.219 to 0.654
Parameter Dispersion
Type: Standard Deviation
Value: 3.053
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 1.07
Confidence Interval 95%
0.497 to 1.634
Parameter Dispersion
Type: Standard Deviation
Value: 3.775
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78
Hide Description Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 192 167
Mean (Standard Deviation)
Unit of Measure: mmol/L
-1.08  (3.662) -0.99  (3.467)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -1.08
Confidence Interval 95%
-1.605 to -0.562
Parameter Dispersion
Type: Standard Deviation
Value: 3.662
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.99
Confidence Interval 95%
-1.517 to -0.458
Parameter Dispersion
Type: Standard Deviation
Value: 3.467
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78
Hide Description Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 192 168
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.26  (4.158) -0.37  (3.838)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3859
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.26
Confidence Interval 95%
-0.331 to 0.853
Parameter Dispersion
Type: Standard Deviation
Value: 4.158
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2119
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.37
Confidence Interval 95%
-0.956 to 0.214
Parameter Dispersion
Type: Standard Deviation
Value: 3.838
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78
Hide Description Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 190 166
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.35  (3.975) -0.95  (3.230)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2290
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.35
Confidence Interval 95%
-0.917 to 0.2211
Parameter Dispersion
Type: Standard Deviation
Value: 3.975
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.95
Confidence Interval 95%
-1.449 to -0.459
Parameter Dispersion
Type: Standard Deviation
Value: 3.230
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26
Hide Description Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 207 197
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-3.20  (0.31) -3.93  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0124
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 0.73
Confidence Interval 95%
0.16 to 1.31
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26
Hide Description Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time Frame week 0. week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 208 196
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-2.74  (0.28) -2.35  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1430
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.39
Confidence Interval 95%
-0.91 to 0.13
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26
Hide Description Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 206 197
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-3.05  (0.28) -3.59  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0380
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 0.54
Confidence Interval 95%
0.03 to 1.05
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Hide Description Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 191 173
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.06  (2.827) 0.72  (3.270)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7700
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.06
Confidence Interval 95%
-0.344 to 0.463
Parameter Dispersion
Type: Standard Deviation
Value: 2.827
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0042
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.72
Confidence Interval 95%
0.230 to 1.212
Parameter Dispersion
Type: Standard Deviation
Value: 3.270
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Hide Description Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 191 173
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.67  (3.041) -0.09  (2.989)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.67
Confidence Interval 95%
0.238 to 1.106
Parameter Dispersion
Type: Standard Deviation
Value: 3.041
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6845
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.09
Confidence Interval 95%
-0.541 to 0.356
Parameter Dispersion
Type: Standard Deviation
Value: 2.989
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Hide Description Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 191 172
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.32  (2.705) 0.58  (3.114)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1041
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.32
Confidence Interval 95%
-0.066 to 0.706
Parameter Dispersion
Type: Standard Deviation
Value: 2.705
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0151
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.58
Confidence Interval 95%
0.114 to 1.052
Parameter Dispersion
Type: Standard Deviation
Value: 3.114
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78
Hide Description Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 192 168
Mean (Standard Deviation)
Unit of Measure: mmol/L
-3.31  (3.857) -3.13  (3.560)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -3.31
Confidence Interval 95%
-3.861 to -2.763
Parameter Dispersion
Type: Standard Deviation
Value: 3.857
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -3.13
Confidence Interval 95%
-3.673 to -2.589
Parameter Dispersion
Type: Standard Deviation
Value: 3.560
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78
Hide Description Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 192 168
Mean (Standard Deviation)
Unit of Measure: mmol/L
-1.93  (3.703) -2.17  (3.654)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -1.93
Confidence Interval 95%
-2.457 to -1.403
Parameter Dispersion
Type: Standard Deviation
Value: 3.703
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -2.17
Confidence Interval 95%
-2.731 to -1.618
Parameter Dispersion
Type: Standard Deviation
Value: 3.654
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78
Hide Description Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 191 167
Mean (Standard Deviation)
Unit of Measure: mmol/L
-2.21  (3.752) -2.55  (3.625)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -2.21
Confidence Interval 95%
-2.747 to -1.676
Parameter Dispersion
Type: Standard Deviation
Value: 3.752
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -2.55
Confidence Interval 95%
-3.104 to -1.997
Parameter Dispersion
Type: Standard Deviation
Value: 3.625
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Change in Beta-cell Function at Week 26
Hide Description

Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5).

Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 214 214
Least Squares Mean (Standard Error)
Unit of Measure: percentage point (%point)
32.12  (6.75) 2.74  (6.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 29.37
Confidence Interval 95%
16.81 to 41.93
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Change in Beta-cell Function, Weeks 26-78
Hide Description

Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5).

Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 198 179
Mean (Standard Deviation)
Unit of Measure: percentage point (%point)
-18.18  (62.811) 2.29  (52.997)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -18.18
Confidence Interval 95%
-26.988 to -9.382
Parameter Dispersion
Type: Standard Deviation
Value: 62.811
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5304
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 2.49
Confidence Interval 95%
-5.327 to 10.307
Parameter Dispersion
Type: Standard Deviation
Value: 52.997
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Change in Beta-cell Function at Week 78
Hide Description

Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]‑3.5).

Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 189 176
Mean (Standard Deviation)
Unit of Measure: percentage point (%point)
24.86  (59.326) 11.13  (87.145)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 24.86
Confidence Interval 95%
16.348 to 33.374
Parameter Dispersion
Type: Standard Deviation
Value: 59.326
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0920
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 11.13
Confidence Interval 95%
-1.835 to 24.093
Parameter Dispersion
Type: Standard Deviation
Value: 87.145
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Change in Total Cholesterol at Week 26
Hide Description Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 226 220
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.20  (0.07) -0.09  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0946
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.11
Confidence Interval 95%
-0.23 to 0.02
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Change in Total Cholesterol, Weeks 26-78
Hide Description Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the trial products.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 199 184
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.11  (0.774) 0.12  (0.804)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0513
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.11
Confidence Interval 95%
-0.001 to 0.216
Parameter Dispersion
Type: Standard Deviation
Value: 0.774
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0513
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.12
Confidence Interval 95%
-0.001 to 0.233
Parameter Dispersion
Type: Standard Deviation
Value: 0.804
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Change in Total Cholesterol at Week 78
Hide Description Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 198 183
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.07  (0.859) 0.09  (0.890)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2764
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.07
Confidence Interval 95%
-0.187 to 0.054
Parameter Dispersion
Type: Standard Deviation
Value: 0.859
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1911
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.09
Confidence Interval 95%
-0.043 to 0.216
Parameter Dispersion
Type: Standard Deviation
Value: 0.890
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Change in Low-density Lipoprotein-cholesterol at Week 26
Hide Description Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 219 215
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.44  (0.06) -0.40  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4412
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.04
Confidence Interval 95%
-0.15 to 0.06
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Change in Low-density Lipoprotein-cholesterol, Weeks 26-78
Hide Description Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 199 180
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.03  (0.606) 0.08  (0.720)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4746
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.03
Confidence Interval 95%
-0.054 to 0.115
Parameter Dispersion
Type: Standard Deviation
Value: 0.606
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1281
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.08
Confidence Interval 95%
-0.024 to 0.188
Parameter Dispersion
Type: Standard Deviation
Value: 0.720
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Change in Low-density Lipoprotein-cholesterol at Week 78
Hide Description Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 183 176
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.30  (0.604) -0.21  (0.647)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.30
Confidence Interval 95%
-0.390 to -0.214
Parameter Dispersion
Type: Standard Deviation
Value: 0.604
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value -0.21
Confidence Interval 95%
-0.303 to -0.110
Parameter Dispersion
Type: Standard Deviation
Value: 0.647
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Change in Very Low-density Lipoprotein-cholesterol at Week 26
Hide Description Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 216 212
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.20  (0.04) 0.27  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0277
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value -0.07
Confidence Interval 95%
-0.13 to -0.01
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78
Hide Description Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 199 180
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.06  (0.290) 0.03  (0.307)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0030
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.06
Confidence Interval 95%
0.021 to 0.102
Parameter Dispersion
Type: Standard Deviation
Value: 0.290
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1452
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.03
Confidence Interval 95%
-0.012 to 0.079
Parameter Dispersion
Type: Standard Deviation
Value: 0.307
Estimation Comments [Not Specified]
41.Secondary Outcome
Title Change in Very Low-density Lipoprotein-cholesterol at Week 78
Hide Description Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Time Frame week 0, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 173 168
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.27  (0.306) 0.31  (0.346)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.27
Confidence Interval 95%
0.223 to 0.315
Parameter Dispersion
Type: Standard Deviation
Value: 0.306
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide -> Liraglutide -> Liraglutide
Comments The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean
Estimated Value 0.31
Confidence Interval 95%
0.259 to 0.364
Parameter Dispersion
Type: Standard Deviation
Value: 0.346
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Change in High-density Lipoprotein-cholesterol at Week 26
Hide Description Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 226 220
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.04  (0.02) -0.05  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide, Exenatide -> Liraglutide -> Liraglutide
Comments ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5105
Comments There were no multiplicity concerns.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference, LS Mean
Estimated Value 0.01
Confidence Interval 95%
-0.02 to 0.04
Estimation Comments [Not Specified]
43.Secondary Outcome
Title Change in High-density Lipoprotein-cholesterol, Weeks 26-78
Hide Description Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -> liraglutide group and the exenatide -> liraglutide group).
Time Frame week 26, week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
Arm/Group Title Liraglutide -> Liraglutide -> Liraglutide Exenatide -> Liraglutide -> Liraglutide
Hide Arm/Group Description:
Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Overall Number of Participants Analyzed 119 180
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.01  (0.150) 0.00  (0.141)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide -> Liraglutide -> Liraglutide
Comments A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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