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Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01029886
Recruitment Status : Completed
First Posted : December 10, 2009
Results First Posted : March 21, 2012
Last Update Posted : April 9, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide once weekly
Drug: liraglutide

  Participant Flow


  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
Exenatide Once Weekly Subcutaneous injection, 2mg, once weekly
Liraglutide Once Daily Subcutaneous injection, forced titration to 1.8mg, once daily
Total Total of all reporting groups

Baseline Measures
   Exenatide Once Weekly   Liraglutide Once Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 461   450   911 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   386   360   746 
>=65 years   75   90   165 
Age 
[Units: Years]
Mean (Standard Deviation) 		 56.6  (9.43)   56.7  (9.59)   56.6  (9.51) 
Gender 
[Units: Participants]
 		     
Female   207   205   412 
Male   254   245   499 
Glycosylated hemoglobin (HbA1c) 
[Units: Percentage of total hemoglobin]
Mean (Standard Deviation) 		 8.45  (1.014)   8.43  (0.996)   8.44  (1.004) 
Weight 
[Units: Kg]
Mean (Standard Deviation) 		 90.88  (19.472)   91.13  (19.118)   91.00  (19.288) 
Background Oral Antidiabetic Agent (OAD) 
[Units: Participants]
 		     
Metformin (MET)   150   136   286 
Sulfonylurea (SU)   18   18   36 
Pioglitazone (PIO)   1   0   1 
MET+SU   275   277   552 
MET+PIO   16   18   34 
MET+SU+PIO   1   1   2 


  Outcome Measures

1.  Primary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Patients Achieving HbA1c <7.0% at Week 26   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 2

3.  Secondary:   Change in Fasting Serum Glucose From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 3

4.  Secondary:   Change in Body Weight From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 4

5.  Secondary:   Change in Total Cholesterol From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 5

6.  Secondary:   Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 6

7.  Secondary:   Ratio of Fasting Triglycerides at Week 26 to Baseline   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 7

8.  Secondary:   Change in Systolic Blood Pressure (SBP) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
  Show Outcome Measure 8

9.  Secondary:   Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
  Hide Outcome Measure 9

Measure Type Secondary
Measure Title Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
Measure Description Change in DBP from baseline to the treatment endpoint at Week 26.
Time Frame Baseline, 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.
ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.

Reporting Groups
  Description
Exenatide Once Weekly Subcutaneous injection, 2mg, once weekly
Liraglutide Once Daily Subcutaneous injection, forced titration to 1.8mg, once daily

Measured Values
   Exenatide Once Weekly   Liraglutide Once Daily 
Participants Analyzed 
[Units: Participants]
 		 404   398 
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26 
[Units: mmHg]
Least Squares Mean (Standard Error) 		 -0.49  (0.37)   -0.51  (0.37) 


Statistical Analysis 1 for Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Mixed Models Analysis
P Value [4] 0.981
Least Squares Mean Difference [5] 0.01
95% Confidence Interval -0.96 to 0.98
Standard Error of the mean (0.50)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.
[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.



10.  Secondary:   Assessment of Event Rate of Treatment-emergent Hypoglycemic Events   [ Time Frame: Baseline to Week 26 ]
  Show Outcome Measure 10


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information