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Effect on Weight Loss of Exenatide Versus Placebo

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00375492
First received: September 11, 2006
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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  
Subject Decision                 6                 6  



  Baseline Characteristics
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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: %]
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: %]
Mean ± Standard Deviation 		  75.15  ± 81.20     70.72  ± 53.16     72.81  ± 67.65  
Baseline Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S)  
[units: %]
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 in Body Weight   [ Time Frame: 24 weeks ]
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2.  Secondary:   Change in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: 24 weeks ]
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3.  Secondary:   Change in 6-point Self Monitored Blood Glucose (SMBG) Profile.   [ Time Frame: 24 weeks ]
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4.  Secondary:   Change in Waist Circumference.   [ Time Frame: 24 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change in Homeostatic Model Assessment-Beta Cell (HOMA-B)   [ Time Frame: 24 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change in Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S)   [ Time Frame: 24 weeks ]
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7.  Secondary:   Change in High Density Lipoprotein (HDL) Cholesterol   [ Time Frame: 24 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change in Low Density Lipoprotein (LDL) Cholesterol   [ Time Frame: 24 weeks ]
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9.  Secondary:   Change in Total Cholesterol   [ Time Frame: 24 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change in Triglycerides   [ Time Frame: 24 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Incidence of Hypoglycemic Events   [ Time Frame: 24 weeks ]
  Show Outcome Measure 11

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


  Serious Adverse Events
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  Other Adverse Events
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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 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
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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 Amylin Pharmaceuticals, LLC.

Publications automatically indexed to this study:


Responsible Party: Amylin Pharmaceuticals, LLC.
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: February 26, 2013
Health Authority: United States: Food and Drug Administration