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 ]

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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Exenatide BID     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     38/43     25/37  
Ear and labyrinth disorders      
vertigo * 1    
# participants affected / at risk     3/43 (6.98%)     0/37 (0.00%)  
Gastrointestinal disorders      
Nausea * 1    
# participants affected / at risk     15/43 (34.88%)     11/37 (29.73%)  
Diarrhoea * 1    
# participants affected / at risk     7/43 (16.28%)     1/37 (2.70%)  
Vomiting * 1    
# participants affected / at risk     7/43 (16.28%)     3/37 (8.11%)  
Abdominal pain upper * 1    
# participants affected / at risk     4/43 (9.30%)     1/37 (2.70%)  
Dyspepsia * 1    
# participants affected / at risk     2/43 (4.65%)     6/37 (16.22%)  
Abdominal discomfort * 1    
# participants affected / at risk     1/43 (2.33%)     2/37 (5.41%)  
General disorders      
Fatigue * 1    
# participants affected / at risk     5/43 (11.63%)     1/37 (2.70%)  
Injection site reaction * 1    
# participants affected / at risk     2/43 (4.65%)     2/37 (5.41%)  
Infections and infestations      
Nasopharyngitis * 1    
# participants affected / at risk     8/43 (18.60%)     7/37 (18.92%)  
Influenza * 1    
# participants affected / at risk     3/43 (6.98%)     2/37 (5.41%)  
Metabolism and nutrition disorders      
Decreased appetite * 1    
# participants affected / at risk     8/43 (18.60%)     4/37 (10.81%)  
Hyperglycaemia * 1    
# participants affected / at risk     0/43 (0.00%)     2/37 (5.41%)  
Musculoskeletal and connective tissue disorders      
Back pain * 1    
# participants affected / at risk     3/43 (6.98%)     2/37 (5.41%)  
Myalgia * 1    
# participants affected / at risk     3/43 (6.98%)     0/37 (0.00%)  
Arthralgia * 1    
# participants affected / at risk     1/43 (2.33%)     3/37 (8.11%)  
Nervous system disorders      
Headache * 1    
# participants affected / at risk     6/43 (13.95%)     5/37 (13.51%)  
Dizziness * 1    
# participants affected / at risk     2/43 (4.65%)     3/37 (8.11%)  
Respiratory, thoracic and mediastinal disorders      
Cough * 1    
# participants affected / at risk     1/43 (2.33%)     2/37 (5.41%)  
Oropharyngeal pain * 1    
# participants affected / at risk     1/43 (2.33%)     2/37 (5.41%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (15.0)



  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