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Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

This study has been terminated.
(Enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00701935
First received: June 17, 2008
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: January 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: placebo
Drug: exenatide

  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

Initial planned enrolment was 12 months, starting August 2008. Eventual enrolment time was 3+ years – decision made to close end of 2011.

Number of patients initially planned: 94 randomized and 74 completers Final number of patients: 80 randomized and 53 completers


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 BID Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Placebo Subcutaneous injection of placebo twice a day for 6 months

Participant Flow:   Overall Study
    Exenatide BID     Placebo  
STARTED     43     37  
COMPLETED     27     26  
NOT COMPLETED     16     11  



  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 BID Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Placebo Subcutaneous injection of placebo twice a day for 6 months
Total Total of all reporting groups

Baseline Measures
    Exenatide BID     Placebo     Total  
Number of Participants  
[units: participants]
  43     37     80  
Age  
[units: years]
Mean ± Standard Deviation
  58.2  ± 12.2     57.9  ± 11.0     58.1  ± 11.6  
Gender  
[units: participants]
     
Female     20     18     38  
Male     23     19     42  



  Outcome Measures
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1.  Primary:   Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]
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Measure Type Primary
Measure Title Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
Measure Description Percentage change in abdominal visceral fat
Time Frame baseline, 6 months  
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.
Primary analysis done on the Intent To Treat (ITT) Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received

Reporting Groups
  Description
Exenatide BID Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
Placebo Subcutaneous injection of placebo twice a day for 6 months

Measured Values
    Exenatide BID     Placebo  
Number of Participants Analyzed  
[units: participants]
  29     27  
Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months  
[units: %┬áchange]
Least Squares Mean ± Standard Error
  -5.28  ± 3.23     -4.30  ± 3.53  


Statistical Analysis 1 for Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.8252
Mean Difference (Final Values) [4] -0.98
Standard Error of the mean ± 4.432
95% Confidence Interval ( -9.92 to 7.95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The power calculation is based on a two-sided t-test and significance level of 0.05.

Hypotheses for sample size:

Power: 80% Drop-out rate: 20% Difference in the percentage change in abdominal visceral fat from baseline to 6 months between exenatide and placebo: 10% Common standard deviation: 15%

94 patients are needed to attain the 37 patients randomized and analyzed in each group.

[2] Other relevant method information, such as adjustments or degrees of freedom:
  The ANCOVA model includes terms of treatment, gender, investigator and baseline abdominal visceral fat.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  p-values were not adjusted for multiple comparisons.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Percentage Change in Total Abdominal Fat From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

3.  Secondary:   Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

4.  Secondary:   Change in HbA1c From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

5.  Secondary:   Percentage of Patients With HbA1c <=7.0% at 6 Months   [ Time Frame: 6 months ]

6.  Secondary:   Change in Fasting Plasma Glucose From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

7.  Secondary:   Change in Weight From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

8.  Secondary:   Change in Systolic Blood Pressure From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

9.  Secondary:   Change in Diastolic Blood Pressure From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

10.  Secondary:   Change in Total Cholesterol From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

11.  Secondary:   Change in Triglycerides From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

12.  Secondary:   Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months   [ Time Frame: baseline, 6 months ]

13.  Secondary:   Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event   [ Time Frame: baseline, 6 months ]


  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
The dropout rate in the study was higher than anticipated (of 80 patients randomized, only 53 completed Study Period II), and enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00701935     History of Changes
Other Study ID Numbers: H8O-CA-GWCE
Study First Received: June 17, 2008
Results First Received: January 11, 2013
Last Updated: June 6, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration