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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01029886
First received: December 8, 2009
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
Results First Received: February 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide once weekly
Drug: liraglutide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Participant Flow:   Overall Study
    Exenatide Once Weekly     Liraglutide Once Daily  
STARTED     461     451  
Intent to Treat (ITT)     461     450  
COMPLETED     400     391  
NOT COMPLETED     61     60  
Adverse Event                 12                 25  
Lost to Follow-up                 1                 0  
Physician Decision                 2                 6  
Protocol Violation                 17                 5  
Withdrawal by Subject                 8                 18  
Entry Criteria Not Met                 13                 5  
Sponsor Decision                 1                 0  
Loss Glucose Control                 7                 1  



  Baseline Characteristics
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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  
Number of Participants  
[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
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1.  Primary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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2.  Secondary:   Percentage of Patients Achieving HbA1c <7.0% at Week 26   [ Time Frame: Baseline, Week 26 ]
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3.  Secondary:   Change in Fasting Serum Glucose From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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4.  Secondary:   Change in Body Weight From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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5.  Secondary:   Change in Total Cholesterol From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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6.  Secondary:   Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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7.  Secondary:   Ratio of Fasting Triglycerides at Week 26 to Baseline   [ Time Frame: Baseline, Week 26 ]
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8.  Secondary:   Change in Systolic Blood Pressure (SBP) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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9.  Secondary:   Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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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  
Safety Issue No  

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  
Number of 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
Method [2] Mixed Models Analysis
P Value [3] 0.981
Least Squares Mean Difference [4] 0.01
Standard Error of the mean ± 0.50
95% Confidence Interval ( -0.96 to 0.98 )
[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] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] 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.
[4] Other relevant estimation information:
  No text entered.



10.  Secondary:   Assessment of Event Rate of Treatment-emergent Hypoglycemic Events   [ Time Frame: Baseline to Week 26 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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