Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: March 23, 2015
Last verified: March 2015
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Other Adverse Events

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 (88.37%)   25/37 (67.57%) 
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
  Hide Limitations and Caveats

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