Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00603239
First received: January 17, 2008
Last updated: September 17, 2013
Last verified: September 2013
Results First Received: July 20, 2010  
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
A total of 165 patients, experiencing inadequate glycemic control using a thiazolidinedione (TZD) alone or in combination with metformin, following a 2-week placebo lead-in period, were randomly assigned in a proportion of 2:1 to add exenatide (111 patients) or placebo (54 patients) to their current therapy regimen.

Reporting Groups
  Description
Exenatide Twice Daily (BID) Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
Placebo Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks

Participant Flow:   Overall Study
    Exenatide Twice Daily (BID)     Placebo  
STARTED     111     54  
COMPLETED     96     50  
NOT COMPLETED     15     4  
Adverse Event                 4                 1  
Entry criteria not met                 0                 1  
Loss of glucose control                 3                 0  
Lost to Follow-up                 2                 1  
Physician Decision                 2                 0  
Protocol Violation                 2                 0  
Subject decision                 2                 1  



  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 Twice Daily (BID) Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
Placebo Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
Total Total of all reporting groups

Baseline Measures
    Exenatide Twice Daily (BID)     Placebo     Total  
Number of Participants  
[units: participants]
  111     54     165  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     97     47     144  
>=65 years     14     7     21  
Age  
[units: years]
Mean ± Standard Deviation
  54.93  ± 8.27     54.12  ± 9.36     54.67  ± 8.62  
Gender  
[units: participants]
     
Female     44     23     67  
Male     67     31     98  



  Outcome Measures
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1.  Primary:   Change in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: baseline and 26 weeks ]

2.  Secondary:   Percentage of Patients Achieving HbA1c <= 7%   [ Time Frame: 26 weeks ]

3.  Secondary:   Percentage of Patients Achieving HbA1c <= 6.5%   [ Time Frame: 26 weeks ]

4.  Secondary:   Change in Fasting Serum Glucose (FSG)   [ Time Frame: baseline and 26 weeks ]

5.  Secondary:   Change in Body Weight   [ Time Frame: baseline and 26 weeks ]

6.  Secondary:   Change in Waist Circumference   [ Time Frame: baseline and 26 weeks ]

7.  Secondary:   Change in Beta-cell Function   [ Time Frame: baseline and 26 weeks ]

8.  Secondary:   Change in Insulin Sensitivity.   [ Time Frame: baseline and 26 weeks ]

9.  Secondary:   Number of Subjects Who Experienced an Episode of Minor Hypoglycemia   [ Time Frame: 26 weeks ]

10.  Secondary:   Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score   [ Time Frame: baseline and 26 weeks ]

11.  Secondary:   Change in Euroqol – 5 Domain Quality of Life (EQ-5D) Score   [ Time Frame: baseline and 26 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
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: NCT00603239     History of Changes
Other Study ID Numbers: H8O-MC-GWCG
Study First Received: January 17, 2008
Results First Received: July 20, 2010
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
South Africa: Medicines Control Council
Canada: Health Canada
Romania: National Medicines Agency