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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00518882
First received: August 20, 2007
Last updated: January 25, 2017
Last verified: January 2017
Results First Received: February 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: liraglutide
Drug: exenatide

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Participant Flow for 2 periods

Period 1:   Double-Blind, Week 0-26
    Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide
STARTED   235 [1]   232 [2] 
Randomised   233   231 
COMPLETED   202   187 
NOT COMPLETED   33   45 
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 2:   Open-Label Extension, Week 26-78
    Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide
STARTED   202   187 
COMPLETED   161   138 
NOT COMPLETED   41   49 
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 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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 Total of all reporting groups

Baseline Measures
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide   Total 
Overall Participants Analyzed 
[Units: Participants]
 233   231   464 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.3  (9.8)   57.1  (10.8)   56.7  (10.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      119  51.1%      104  45.0%      223  48.1% 
Male      114  48.9%      127  55.0%      241  51.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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] 
[Units: Participants]
     
Metformin/Sulphonylurea Combination   145   147   292 
Sulphonylurea   24   21   45 
Metformin   64   63   127 
[1] OAD = Oral Anti-diabetic Drug
BMI [1] 
[Units: Kg/m2]
Mean (Standard Deviation)
 32.9  (5.5)   32.9  (5.7)   32.9  (5.6) 
[1] Body Mass Index
Duration of diabetes [1] 
[Units: Years]
Mean (Standard Deviation)
 8.5  (6.2)   7.9  (5.9)   8.2  (6.0) 
[1] Number of years since diagnosis
HbA1c [1] 
[Units: Percentage of total haemoglobin]
Mean (Standard Deviation)
 8.4  (1.0)   8.2  (1.0)   8.3  (1.0) 
[1] Glycosylated Haemoglobin at screening
Height 
[Units: m]
Mean (Standard Deviation)
 1.68  (0.10)   1.68  (0.10)   1.68  (0.10) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 93.1  (20.1)   93.0  (19.5)   93.1  (19.8) 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Change in Glycosylated A1c (HbA1c) at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Primary
Measure Title Change in Glycosylated A1c (HbA1c) at Week 26
Measure Description Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 227   226 
Change in Glycosylated A1c (HbA1c) at Week 26 
[Units: Percentage point of total HbA1c]
Least Squares Mean (Standard Error)
 -1.12  (0.08)   -0.79  (0.08) 


Statistical Analysis 1 for Change in Glycosylated A1c (HbA1c) at Week 26
Groups [1] All groups
Statistical Test Type [2] Non-Inferiority or Equivalence
Statistical Method [3] ANCOVA
P Value [4] <.0001
Estimated treatment difference, LS Mean [5] -0.33
95% Confidence Interval -0.47 to -0.18
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

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%.

[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority concluded if upper confidence interval of test is below 0.4%
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No multiplicity concerns
[5] Other relevant estimation information:
  No text entered.



2.  Secondary:   Change in Glycosylated A1c (HbA1c), Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Glycosylated A1c (HbA1c), Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 198   183 
Change in Glycosylated A1c (HbA1c), Weeks 26-78 
[Units: Percentage point of total HbA1c]
Mean (Standard Deviation)
 0.25  (0.803)   -0.00  (0.924) 


Statistical Analysis 1 for Change in Glycosylated A1c (HbA1c), Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t-test
P Value [4] <0.0001
Mean [5] 0.25
95% Confidence Interval 0.139 to 0.364
Standard Deviation (0.803)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Glycosylated A1c (HbA1c), Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t-test
P Value [4] 0.9872
Mean [5] -0.00
95% Confidence Interval -1.36 to 0.134
Standard Deviation (0.924)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



3.  Secondary:   Change in Glycosylated A1c (HbA1c) at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Glycosylated A1c (HbA1c) at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 198   183 
Change in Glycosylated A1c (HbA1c) at Week 78 
[Units: Percentage point of total HbA1c]
Mean (Standard Deviation)
 -0.98  (1.119)   -0.85  (1.105) 


Statistical Analysis 1 for Change in Glycosylated A1c (HbA1c) at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t-test
P Value [4] <0.0001
Mean [5] -0.98
95% Confidence Interval -1.137 to -0.823
Standard Deviation (1.119)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Glycosylated A1c (HbA1c) at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t-test
P Value [4] <0.0001
Mean [5] -0.85
95% Confidence Interval -1.010 to -0.687
Standard Deviation (1.105)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



4.  Secondary:   Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 233   231 
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 
[Units: Percentage (%) of subjects]
   
Treatment target HbA1c < 7%   53   42 
Treatment target HbA1c =< 6.5%   34   20 

No statistical analysis provided for Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26



5.  Secondary:   Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 200   186 
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 
[Units: Percentage (%) of subjects]
   
Treatment target HbA1c < 7%   47   48 
Treatment target HbA1c =< 6.5%   31   35 

No statistical analysis provided for Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78



6.  Secondary:   Change in Body Weight at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Body Weight at Week 26
Measure Description Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 231   229 
Change in Body Weight at Week 26 
[Units: Kg]
Least Squares Mean (Standard Error)
 -3.24  (0.33)   -2.87  (0.33) 


Statistical Analysis 1 for Change in Body Weight at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.2235
Estimated treatment difference, LS Mean [5] -0.38
95% Confidence Interval -0.99 to 0.23
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



7.  Secondary:   Change in Body Weight, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Body Weight, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 199   184 
Change in Body Weight, Weeks 26-78 
[Units: Kg]
Mean (Standard Deviation)
 -0.4  (3.24)   -0.7  (3.67) 


Statistical Analysis 1 for Change in Body Weight, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0793
Mean [5] -0.4
95% Confidence Interval -0.86 to 0.05
Standard Deviation (3.24)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Body Weight, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0075
Mean [5] -0.7
95% Confidence Interval -1.26 to -0.20
Standard Deviation (3.67)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



8.  Secondary:   Change in Body Weight at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Body Weight at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 199   184 
Change in Body Weight at Week 78 
[Units: Kg]
Mean (Standard Deviation)
 -3.3  (4.63)   -3.2  (4.44) 


Statistical Analysis 1 for Change in Body Weight at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -3.3
95% Confidence Interval -3.90 to -2.61
Standard Deviation (4.63)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Body Weight at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -3.2
95% Confidence Interval -3.85 to -2.55
Standard Deviation (4.44)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



9.  Secondary:   Change in Fasting Plasma Glucose at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Fasting Plasma Glucose at Week 26
Measure Description Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 225   219 
Change in Fasting Plasma Glucose at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -1.61  (0.20)   -0.60  (0.20) 


Statistical Analysis 1 for Change in Fasting Plasma Glucose at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <0.0001
Estimated treatment difference, LS Mean [5] -1.01
95% Confidence Interval -1.37 to -0.65
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



10.  Secondary:   Change in Fasting Plasma Glucose, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Fasting Plasma Glucose, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 197   182 
Change in Fasting Plasma Glucose, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.7  (1.84)   -0.1  (2.42) 


Statistical Analysis 1 for Change in Fasting Plasma Glucose, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] 0.7
95% Confidence Interval 0.48 to 1.00
Standard Deviation (1.84)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Fasting Plasma Glucose, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.4864
Mean [5] -0.1
95% Confidence Interval -0.48 to 0.23
Standard Deviation (2.42)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



11.  Secondary:   Change in Fasting Plasma Glucose at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Fasting Plasma Glucose at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 197   182 
Change in Fasting Plasma Glucose at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -1.3  (2.50)   -0.8  (2.76) 


Statistical Analysis 1 for Change in Fasting Plasma Glucose at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -1.3
95% Confidence Interval -1.62 to -0.92
Standard Deviation (2.50)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Fasting Plasma Glucose at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -0.8
95% Confidence Interval -1.23 to -0.42
Standard Deviation (2.76)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



12.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 207   196 
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -0.83  (0.28)   -2.16  (0.28) 


Statistical Analysis 1 for Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <.0001
Estimated treatment difference, LS Mean [5] 1.33
95% Confidence Interval 0.80 to 1.86
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



13.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 207   196 
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 0.06  (0.28)   0.06  (0.28) 


Statistical Analysis 1 for Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.9849
Estimated treatment difference, LS Mean [5] 0.01
95% Confidence Interval -0.52 to 0.53
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



14.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 204   196 
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -1.10  (0.31)   -2.11  (0.31) 


Statistical Analysis 1 for Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.0005
LS Mean [5] 1.01
95% Confidence Interval 0.44 to 1.57
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



15.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 191   173 
Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 -0.22  (2.866)   1.15  (3.253) 


Statistical Analysis 1 for Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.2972
Mean [5] -0.22
95% Confidence Interval -0.626 to 0.192
Standard Deviation (2.866)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] 1.15
95% Confidence Interval 0.660 to 1.637
Standard Deviation (3.253)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



16.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 191   173 
Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.05  (3.307)   -0.09  (3.419) 


Statistical Analysis 1 for Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.8396
Mean [5] 0.05
95% Confidence Interval -0.424 to 0.521
Standard Deviation (3.307)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.7278
Mean [5] -0.09
95% Confidence Interval -0.604 to 0.423
Standard Deviation (3.419)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



17.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 190   172 
Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.22  (3.053)   1.07  (3.775) 


Statistical Analysis 1 for Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.3271
Mean [5] 0.22
95% Confidence Interval -0.219 to 0.654
Standard Deviation (3.053)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0003
Mean [5] 1.07
95% Confidence Interval 0.497 to 1.634
Standard Deviation (3.775)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



18.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 192   167 
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -1.08  (3.662)   -0.99  (3.467) 


Statistical Analysis 1 for Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -1.08
95% Confidence Interval -1.605 to -0.562
Standard Deviation (3.662)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0003
Mean [5] -0.99
95% Confidence Interval -1.517 to -0.458
Standard Deviation (3.467)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



19.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 192   168 
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.26  (4.158)   -0.37  (3.838) 


Statistical Analysis 1 for Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.3859
Mean [5] 0.26
95% Confidence Interval -0.331 to 0.853
Standard Deviation (4.158)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.2119
Mean [5] -0.37
95% Confidence Interval -0.956 to 0.214
Standard Deviation (3.838)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



20.  Secondary:   Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 190   166 
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -0.35  (3.975)   -0.95  (3.230) 


Statistical Analysis 1 for Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.2290
Mean [5] -0.35
95% Confidence Interval -0.917 to 0.2211
Standard Deviation (3.975)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0002
Mean [5] -0.95
95% Confidence Interval -1.449 to -0.459
Standard Deviation (3.230)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



21.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 207   197 
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -3.20  (0.31)   -3.93  (0.30) 


Statistical Analysis 1 for Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.0124
Estimated treatment difference, LS Mean [5] 0.73
95% Confidence Interval 0.16 to 1.31
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



22.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26   [ Time Frame: week 0. week 26 ]

Measure Type Secondary
Measure Title Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 208   196 
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -2.74  (0.28)   -2.35  (0.28) 


Statistical Analysis 1 for Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.1430
Estimated treatment difference, LS Mean [5] -0.39
95% Confidence Interval -0.91 to 0.13
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



23.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 206   197 
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -3.05  (0.28)   -3.59  (0.27) 


Statistical Analysis 1 for Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.0380
Estimated treatment difference, LS Mean [5] 0.54
95% Confidence Interval 0.03 to 1.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



24.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 191   173 
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.06  (2.827)   0.72  (3.270) 


Statistical Analysis 1 for Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.7700
Mean [5] 0.06
95% Confidence Interval -0.344 to 0.463
Standard Deviation (2.827)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0042
Mean [5] 0.72
95% Confidence Interval 0.230 to 1.212
Standard Deviation (3.270)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



25.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 191   173 
Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.67  (3.041)   -0.09  (2.989) 


Statistical Analysis 1 for Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0026
Mean [5] 0.67
95% Confidence Interval 0.238 to 1.106
Standard Deviation (3.041)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.6845
Mean [5] -0.09
95% Confidence Interval -0.541 to 0.356
Standard Deviation (2.989)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



26.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 191   172 
Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.32  (2.705)   0.58  (3.114) 


Statistical Analysis 1 for Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.1041
Mean [5] 0.32
95% Confidence Interval -0.066 to 0.706
Standard Deviation (2.705)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0151
Mean [5] 0.58
95% Confidence Interval 0.114 to 1.052
Standard Deviation (3.114)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



27.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 192   168 
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -3.31  (3.857)   -3.13  (3.560) 


Statistical Analysis 1 for Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -3.31
95% Confidence Interval -3.861 to -2.763
Standard Deviation (3.857)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -3.13
95% Confidence Interval -3.673 to -2.589
Standard Deviation (3.560)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



28.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 192   168 
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -1.93  (3.703)   -2.17  (3.654) 


Statistical Analysis 1 for Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -1.93
95% Confidence Interval -2.457 to -1.403
Standard Deviation (3.703)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -2.17
95% Confidence Interval -2.731 to -1.618
Standard Deviation (3.654)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



29.  Secondary:   Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 191   167 
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -2.21  (3.752)   -2.55  (3.625) 


Statistical Analysis 1 for Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -2.21
95% Confidence Interval -2.747 to -1.676
Standard Deviation (3.752)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -2.55
95% Confidence Interval -3.104 to -1.997
Standard Deviation (3.625)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



30.  Secondary:   Change in Beta-cell Function at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Beta-cell Function at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 214   214 
Change in Beta-cell Function at Week 26 
[Units: Percentage point (%point)]
Least Squares Mean (Standard Error)
 32.12  (6.75)   2.74  (6.75) 


Statistical Analysis 1 for Change in Beta-cell Function at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <.0001
Estimated treatment difference, LS Mean [5] 29.37
95% Confidence Interval 16.81 to 41.93
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



31.  Secondary:   Change in Beta-cell Function, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Beta-cell Function, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 198   179 
Change in Beta-cell Function, Weeks 26-78 
[Units: Percentage point (%point)]
Mean (Standard Deviation)
 -18.18  (62.811)   2.29  (52.997) 


Statistical Analysis 1 for Change in Beta-cell Function, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -18.18
95% Confidence Interval -26.988 to -9.382
Standard Deviation (62.811)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Beta-cell Function, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.5304
Mean [5] 2.49
95% Confidence Interval -5.327 to 10.307
Standard Deviation (52.997)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



32.  Secondary:   Change in Beta-cell Function at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Beta-cell Function at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 189   176 
Change in Beta-cell Function at Week 78 
[Units: Percentage point (%point)]
Mean (Standard Deviation)
 24.86  (59.326)   11.13  (87.145) 


Statistical Analysis 1 for Change in Beta-cell Function at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] 24.86
95% Confidence Interval 16.348 to 33.374
Standard Deviation (59.326)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Beta-cell Function at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0920
Mean [5] 11.13
95% Confidence Interval -1.835 to 24.093
Standard Deviation (87.145)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



33.  Secondary:   Change in Total Cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Total Cholesterol at Week 26
Measure Description Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 226   220 
Change in Total Cholesterol at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -0.20  (0.07)   -0.09  (0.07) 


Statistical Analysis 1 for Change in Total Cholesterol at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.0946
Estimated treatment difference, LS Mean [5] -0.11
95% Confidence Interval -0.23 to 0.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



34.  Secondary:   Change in Total Cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Total Cholesterol, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 199   184 
Change in Total Cholesterol, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.11  (0.774)   0.12  (0.804) 


Statistical Analysis 1 for Change in Total Cholesterol, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0513
Mean [5] 0.11
95% Confidence Interval -0.001 to 0.216
Standard Deviation (0.774)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Total Cholesterol, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0513
Mean [5] 0.12
95% Confidence Interval -0.001 to 0.233
Standard Deviation (0.804)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



35.  Secondary:   Change in Total Cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Total Cholesterol at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 198   183 
Change in Total Cholesterol at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -0.07  (0.859)   0.09  (0.890) 


Statistical Analysis 1 for Change in Total Cholesterol at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.2764
Mean [5] -0.07
95% Confidence Interval -0.187 to 0.054
Standard Deviation (0.859)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Total Cholesterol at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.1911
Mean [5] 0.09
95% Confidence Interval -0.043 to 0.216
Standard Deviation (0.890)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



36.  Secondary:   Change in Low-density Lipoprotein-cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Low-density Lipoprotein-cholesterol at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 219   215 
Change in Low-density Lipoprotein-cholesterol at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -0.44  (0.06)   -0.40  (0.06) 


Statistical Analysis 1 for Change in Low-density Lipoprotein-cholesterol at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.4412
Estimated treatment difference, LS Mean [5] -0.04
95% Confidence Interval -0.15 to 0.06
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



37.  Secondary:   Change in Low-density Lipoprotein-cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Low-density Lipoprotein-cholesterol, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 199   180 
Change in Low-density Lipoprotein-cholesterol, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.03  (0.606)   0.08  (0.720) 


Statistical Analysis 1 for Change in Low-density Lipoprotein-cholesterol, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.4746
Mean [5] 0.03
95% Confidence Interval -0.054 to 0.115
Standard Deviation (0.606)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Low-density Lipoprotein-cholesterol, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.1281
Mean [5] 0.08
95% Confidence Interval -0.024 to 0.188
Standard Deviation (0.720)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



38.  Secondary:   Change in Low-density Lipoprotein-cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Low-density Lipoprotein-cholesterol at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 183   176 
Change in Low-density Lipoprotein-cholesterol at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -0.30  (0.604)   -0.21  (0.647) 


Statistical Analysis 1 for Change in Low-density Lipoprotein-cholesterol at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -0.30
95% Confidence Interval -0.390 to -0.214
Standard Deviation (0.604)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Low-density Lipoprotein-cholesterol at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] -0.21
95% Confidence Interval -0.303 to -0.110
Standard Deviation (0.647)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



39.  Secondary:   Change in Very Low-density Lipoprotein-cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Very Low-density Lipoprotein-cholesterol at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 216   212 
Change in Very Low-density Lipoprotein-cholesterol at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 0.20  (0.04)   0.27  (0.04) 


Statistical Analysis 1 for Change in Very Low-density Lipoprotein-cholesterol at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.0277
Estimated treatment difference, LS Mean [5] -0.07
95% Confidence Interval -0.13 to -0.01
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



40.  Secondary:   Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 199   180 
Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.06  (0.290)   0.03  (0.307) 


Statistical Analysis 1 for Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0030
Mean [5] 0.06
95% Confidence Interval 0.021 to 0.102
Standard Deviation (0.290)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.1452
Mean [5] 0.03
95% Confidence Interval -0.012 to 0.079
Standard Deviation (0.307)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



41.  Secondary:   Change in Very Low-density Lipoprotein-cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Very Low-density Lipoprotein-cholesterol at Week 78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 173   168 
Change in Very Low-density Lipoprotein-cholesterol at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.27  (0.306)   0.31  (0.346) 


Statistical Analysis 1 for Change in Very Low-density Lipoprotein-cholesterol at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] 0.27
95% Confidence Interval 0.223 to 0.315
Standard Deviation (0.306)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Very Low-density Lipoprotein-cholesterol at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] <0.0001
Mean [5] 0.31
95% Confidence Interval 0.259 to 0.364
Standard Deviation (0.346)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



42.  Secondary:   Change in High-density Lipoprotein-cholesterol at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in High-density Lipoprotein-cholesterol at Week 26
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 226   220 
Change in High-density Lipoprotein-cholesterol at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -0.04  (0.02)   -0.05  (0.02) 


Statistical Analysis 1 for Change in High-density Lipoprotein-cholesterol at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.5105
Estimated treatment difference, LS Mean [5] 0.01
95% Confidence Interval -0.02 to 0.04
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



43.  Secondary:   Change in High-density Lipoprotein-cholesterol, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in High-density Lipoprotein-cholesterol, Weeks 26-78
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 119   180 
Change in High-density Lipoprotein-cholesterol, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 -0.01  (0.150)   0.00  (0.141) 


Statistical Analysis 1 for Change in High-density Lipoprotein-cholesterol, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.2220
Mean [5] -0.01
95% Confidence Interval -0.034 to 0.008
Standard Deviation (0.150)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in High-density Lipoprotein-cholesterol, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.7923
Mean [5] 0.00
95% Confidence Interval -0.018 to 0.024
Standard Deviation (0.141)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



44.  Secondary:   Change in High-density Lipoprotein-cholesterol at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in High-density Lipoprotein-cholesterol at Week 78
Measure Description Change in High-density Lipoprotein-cholesterol (HDL-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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 183   176 
Change in High-density Lipoprotein-cholesterol at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -0.03  (0.159)   -0.02  (0.165) 


Statistical Analysis 1 for Change in High-density Lipoprotein-cholesterol at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0254
Mean [5] -0.03
95% Confidence Interval -0.050 to -0.003
Standard Deviation (0.159)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in High-density Lipoprotein-cholesterol at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.2244
Mean [5] -0.02
95% Confidence Interval -0.040 to 0.009
Standard Deviation (0.165)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



45.  Secondary:   Change in Triglyceride at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Triglyceride at Week 26
Measure Description Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 225   220 
Change in Triglyceride at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -0.41  (0.10)   -0.23  (0.10) 


Statistical Analysis 1 for Change in Triglyceride at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.0485
Estimated treatment difference, LS Mean [5] -0.18
95% Confidence Interval -0.37 to -0.00
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  There were no multiplicity concerns.
[5] Other relevant estimation information:
  No text entered.



46.  Secondary:   Change in Triglyceride, Weeks 26-78   [ Time Frame: week 26, week 78 ]

Measure Type Secondary
Measure Title Change in Triglyceride, Weeks 26-78
Measure Description Change in Triglyceride (TG) 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 198   184 
Change in Triglyceride, Weeks 26-78 
[Units: mmol/L]
Mean (Standard Deviation)
 0.1  (0.82)   -0.0  (0.96) 


Statistical Analysis 1 for Change in Triglyceride, Weeks 26-78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.1161
Mean [5] 0.1
95% Confidence Interval -0.02 to 0.21
Standard Deviation (0.82)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Triglyceride, Weeks 26-78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.7888
Mean [5] -0.0
95% Confidence Interval -0.16 to 0.12
Standard Deviation (0.96)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



47.  Secondary:   Change in Triglyceride at Week 78   [ Time Frame: week 0, week 78 ]

Measure Type Secondary
Measure Title Change in Triglyceride at Week 78
Measure Description Change in triglyceride (TG) 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 198   183 
Change in Triglyceride at Week 78 
[Units: mmol/L]
Mean (Standard Deviation)
 -0.3  (1.07)   -0.1  (1.47) 


Statistical Analysis 1 for Change in Triglyceride at Week 78
Groups [1] Liraglutide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.0003
Mean [5] -0.3
95% Confidence Interval -0.43 to -0.13
Standard Deviation (1.07)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change in Triglyceride at Week 78
Groups [1] Exenatide -> Liraglutide -> Liraglutide
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t test
P Value [4] 0.2078
Mean [5] -0.1
95% Confidence Interval -0.35 to 0.08
Standard Deviation (1.47)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



48.  Secondary:   Change in Free Fatty Acid at Week 26   [ Time Frame: week 0, week 26 ]

Measure Type Secondary
Measure Title Change in Free Fatty Acid at Week 26
Measure Description Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)
Time Frame week 0, week 26  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Reporting Groups
  Description
Liraglutide -> Liraglutide -> Liraglutide 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 -> Liraglutide -> Liraglutide 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)

Measured Values
   Liraglutide -> Liraglutide -> Liraglutide   Exenatide -> Liraglutide -> Liraglutide 
Participants Analyzed 
[Units: Participants]
 220   222 
Change in Free Fatty Acid at Week 26 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 -0.17  (0.02)   -0.10  (0.02) 


Statistical Analysis 1 for Change in Free Fatty Acid at Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.0014
Estimated treatment difference, LS Mean [5] -0.07
95% Confidence Interval -0.11 to -0.03
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: