Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01003184
First received: October 15, 2009
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: November 20, 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: insulin detemir

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
6 patients who were enrolled and randomized, subsequently discontinued the study before receiving study drug. These patients were not included in analysis.

Reporting Groups
  Description
Exenatide Once Weekly Exenatide once weekly : subcutaneous injection, 2mg, once a week
Insulin Detemir Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day

Participant Flow:   Overall Study
    Exenatide Once Weekly     Insulin Detemir  
STARTED     111     111  
Full Analysis Set (FAS)     111     105  
COMPLETED     92     99  
NOT COMPLETED     19     12  
Adverse Event                 12                 5  
Lost to Follow-up                 1                 0  
Loss of glucose control                 1                 1  
Protocol Violation                 3                 0  
Withdrawal by Subject                 1                 6  
Physician Decision                 1                 0  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)   [ Time Frame: Baseline, Week 26 ]

2.  Secondary:   Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)   [ Time Frame: Baseline, Week 26 ]

3.  Secondary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

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

5.  Secondary:   Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint   [ Time Frame: Week 26 ]

6.  Secondary:   Percentage of Patients Achieving ≤7.0% at Endpoint   [ Time Frame: Week 26 ]

7.  Secondary:   Percentage of Patients Achieving ≤6.5% at Endpoint   [ Time Frame: Week 26 ]

8.  Secondary:   Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).   [ Time Frame: Baseline, Week 26 ]

9.  Secondary:   Changes in Systolic Blood Pressure From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

10.  Secondary:   Change in Diastolic Blood Pressure From Baseline to Week 26.   [ Time Frame: Baseline, Week 26 ]

11.  Secondary:   Change in Total Cholesterol From Baseline to Endpoint (Week 26).   [ Time Frame: Baseline, Week 26 ]

12.  Secondary:   Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).   [ Time Frame: Baseline, Week 26 ]

13.  Secondary:   Change in Triglycerides From Baseline to Endpoint (Week 26).   [ Time Frame: Baseline, Week 26 ]

14.  Secondary:   Hypoglycemia Rate Per Year   [ Time Frame: Baseline, Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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