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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: March 19, 2015
Last verified: March 2015
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
No text entered.

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
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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 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
Total Total of all reporting groups

Baseline Measures
   Exenatide Once Weekly   Insulin Detemir   Total 
Overall Participants Analyzed 
[Units: Participants]
 111   105   216 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   74   78   152 
>=65 years   37   27   64 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.2  (9.86)   57.8  (9.48)   58.5  (9.68) 
Gender 
[Units: Participants]
     
Female   40   33   73 
Male   71   72   143 
HbA1c [1] 
[Units: Percentage of total hemoglobin]
Mean (Standard Deviation)
 8.4  (0.85)   8.4  (0.88)   8.4  (0.86) 
[1] At visit 3 (week 0).
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 96.7  (17.03)   97.9  (15.82)   97.3  (16.42) 


  Outcome Measures
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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 ]
  Hide Outcome Measure 12

Measure Type Secondary
Measure Title Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).
Measure Description Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (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.
The analysis was done for the FAS population (as randomised). The last observation carried forward (LOCF) of post baseline values was used for this 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

Measured Values
   Exenatide Once Weekly   Insulin Detemir 
Participants Analyzed 
[Units: Participants]
 105   100 
Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26). 
[Units: mmol/L]
Least Squares Mean (Standard Error)
 0.02  (0.014)   0.04  (0.015) 


Statistical Analysis 1 for Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.4638
Least Squares Mean Difference [4] -0.01
Standard Error of the mean (0.020)
95% Confidence Interval -0.05 to 0.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.
[2] Other relevant method 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:
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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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  More Information