A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00500370
First received: July 10, 2007
Last updated: September 17, 2013
Last verified: September 2013
Results First Received: February 26, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Drug: exenatide
Drug: placebo

  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
Subject recruitment occurred between July 2007 and August 2007 at medical clinics in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, subjects participated in a 1-week, single-blind placebo lead-in period.

Reporting Groups
  Description
Group A (Exenatide) exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
Group B (Placebo) placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP

Participant Flow:   Overall Study
    Group A (Exenatide)     Group B (Placebo)  
STARTED     80     83  
Treatment Start-Baseline (Week 0)     73     79  
Treatment Complete (Week 24)     48     54  
COMPLETED     47 [1]   49 [1]
NOT COMPLETED     33     34  
Adverse Event                 9                 3  
Lost to Follow-up                 10                 10  
Protocol Violation                 2                 4  
Sponsor Decision                 2                 0  
Subject Decision                 10                 17  
[1] COMPLETED = completion of treatment period (Week 24) plus follow-up visit 4 weeks later



  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
Group A (Exenatide) exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
Group B (Placebo) placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
Total Total of all reporting groups

Baseline Measures
    Group A (Exenatide)     Group B (Placebo)     Total  
Number of Participants  
[units: participants]
  73     79     152  
Age  
[units: years]
Mean ± Standard Deviation
  47.01  ± 10.95     45.15  ± 12.74     46.04  ± 11.91  
Gender  
[units: participants]
     
Female     58     67     125  
Male     15     12     27  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Body Weight   [ Time Frame: 24 weeks ]

2.  Secondary:   Change in Body Mass Index (BMI)   [ Time Frame: 24 weeks ]

3.  Secondary:   Change in Waist-to-hip Ratio   [ Time Frame: 24 weeks ]

4.  Secondary:   Percentage of Patients Experiencing >=5% Weight Loss   [ Time Frame: 24 weeks ]

5.  Secondary:   Change in Total Cholesterol   [ Time Frame: 24 weeks ]

6.  Secondary:   Change in High Density Lipoprotein (HDL) Cholesterol   [ Time Frame: 24 weeks ]

7.  Secondary:   Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)   [ Time Frame: 24 weeks ]

8.  Secondary:   Change in Low Density Lipoprotein (LDL) Cholesterol   [ Time Frame: 24 weeks ]

9.  Secondary:   Change in Fasting Serum Glucose   [ Time Frame: 24 weeks ]

10.  Secondary:   Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)   [ Time Frame: 24 weeks ]

11.  Secondary:   Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)   [ Time Frame: 24 weeks ]

12.  Secondary:   Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)   [ Time Frame: 24 weeks ]

13.  Secondary:   Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis   [ Time Frame: 24 weeks ]

14.  Secondary:   Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)   [ Time Frame: 24 weeks ]

15.  Secondary:   Change in High Sensitivity C-reactive Protein (hsCRP)   [ Time Frame: 24 weeks ]

16.  Secondary:   Change in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-LILLYRX
e-mail: clinicaltrials@amylin.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00500370     History of Changes
Other Study ID Numbers: H8O-MC-GWBP
Study First Received: July 10, 2007
Results First Received: February 26, 2009
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration