Effect on Weight Loss of Exenatide Versus Placebo

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00375492
First received: September 11, 2006
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: February 25, 2009  
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: Type 2 Diabetes Mellitus
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One randomized patient per group discontinued before receiving study drug. These patients are not included in the "started" category below.

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

Participant Flow:   Overall Study
    Group A (Exenatide)     Group B (Placebo)  
STARTED     96     98  
COMPLETED     70     72  
NOT COMPLETED     26     26  
Adverse Event                 4                 5  
Entry Criteria Not Met                 0                 1  
Loss of Glucose Control                 0                 1  
Lost to Follow-up                 10                 5  
Physician Decision                 0                 4  
Protocol Violation                 6                 3  
Sponsor Decision                 0                 1  
Withdrawal by Subject                 6                 6  



  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, followed by exenatide 10mcg twice daily for 20 weeks
Group B (Placebo) placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Group A (Exenatide)     Group B (Placebo)     Total  
Number of Participants  
[units: participants]
  96     98     194  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     78     82     160  
>=65 years     18     16     34  
Age  
[units: years]
Mean ± Standard Deviation
  54.52  ± 10.02     55.08  ± 8.97     54.81  ± 9.48  
Gender  
[units: participants]
     
Female     60     61     121  
Male     36     37     73  
Baseline Body Weight  
[units: kg]
Mean ± Standard Deviation
  94.90  ± 16.52     96.16  ± 16.53     95.53  ± 16.05  
Baseline Cholesterol  
[units: mmol/L]
Mean ± Standard Deviation
  4.67  ± 1.03     4.68  ± 0.90     4.68  ± 0.96  
Baseline Glycosylated Hemoglobin (HbA1c)  
[units: percent hemoglobin]
Mean ± Standard Deviation
  7.74  ± 0.87     7.51  ± 0.82     7.62  ± 0.85  
Baseline High Density Lipoprotein (HDL) Cholesterol  
[units: mmol/L]
Mean ± Standard Deviation
  1.18  ± 0.32     1.21  ± 0.31     1.20  ± 0.31  
Baseline Homeostatic Model Assessment-Beta Cell (HOMA-B)  
[units: Percent beta-cell function]
Mean ± Standard Deviation
  75.15  ± 81.20     70.72  ± 53.16     72.81  ± 67.65  
Baseline Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S)  
[units: Percent insulin sensitivity]
Mean ± Standard Deviation
  49.72  ± 32.12     62.90  ± 41.07     56.68  ± 37.57  
Baseline Low Density Lipoprotein (LDL) Cholesterol  
[units: mmol/L]
Mean ± Standard Deviation
  2.74  ± 0.88     2.78  ± 0.82     2.76  ± 0.85  
Baseline Triglycerides  
[units: mmol/L]
Mean ± Standard Deviation
  2.15  ± 0.94     2.13  ± 1.00     2.14  ± 0.97  
Baseline Waist Circumference  
[units: cm]
Mean ± Standard Deviation
  109.64  ± 11.12     108.85  ± 12.10     109.24  ± 11.60  



  Outcome Measures
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1.  Primary:   Change From Baseline in Body Weight   [ Time Frame: Baseline, Week 24 ]

2.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24   [ Time Frame: baseline, Week 24 ]

3.  Secondary:   Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24   [ Time Frame: baseline, Week 24 ]

4.  Secondary:   Change From Baseline in Waist Circumference at Week 24   [ Time Frame: baseline, Week 24 ]

5.  Secondary:   Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline   [ Time Frame: baseline, Week 24 ]

6.  Secondary:   Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline   [ Time Frame: baseline, Week 24 ]

7.  Secondary:   Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24   [ Time Frame: baseline, Week 24 ]

8.  Secondary:   Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24   [ Time Frame: baseline, Week 24 ]

9.  Secondary:   Change From Baseline in Total Cholesterol at Week 24   [ Time Frame: baseline, week 24 ]

10.  Secondary:   Ratio of Triglycerides at Week 24 to Triglycerides at Baseline   [ Time Frame: baseline, Week 24 ]

11.  Secondary:   Number of Participants With Hypoglycemic Events During the Study   [ Time Frame: Baseline to 24 weeks ]

12.  Secondary:   Rate of Hypoglycemic Events   [ Time Frame: 24 weeks ]


  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
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00375492     History of Changes
Other Study ID Numbers: H8O-US-GWBM
Study First Received: September 11, 2006
Results First Received: February 25, 2009
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration