Safety of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Treated With Thiazolidinedione Alone or Thiazolidinedione in Combination With Metformin

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00753896
First received: September 15, 2008
Last updated: September 17, 2013
Last verified: September 2013
Results First Received: February 14, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Intervention: Drug: exenatide

  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
Exenatide Once Weekly Subcutaneous injection, 2.0mcg, once weekly.

Participant Flow:   Overall Study
    Exenatide Once Weekly  
STARTED     134  
COMPLETED     118  
NOT COMPLETED     16  
Adverse Event                 4  
Death                 1  
Lost to Follow-up                 2  
Protocol Violation                 1  
Withdrawal by Subject                 4  
Entry Criteria Not Met                 4  



  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.
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Reporting Groups
  Description
Exenatide Once Weekly Subcutaneous injection, 2.0mcg, once weekly.

Baseline Measures
    Exenatide Once Weekly  
Number of Participants  
[units: participants]
  134  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     114  
>=65 years     20  
Age  
[units: years]
Mean ± Standard Deviation
  55.0  ± 9.74  
Gender  
[units: participants]
 
Female     60  
Male     74  
Glycosylated hemoglobin (HbA1c)  
[units: percentage of total hemoglobin]
Mean ± Standard Deviation
  7.2  ± 0.95  
Weight  
[units: kg]
Mean ± Standard Deviation
  98.1  ± 18.71  
Background Oral Antidiabetic Agent  
[units: participants]
 
Metformin + Thiazolidinedione (TZD)     118  
TZD     16  



  Outcome Measures
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1.  Primary:   Percentage of Patients Experiencing Adverse Events   [ Time Frame: Baseline to Week 52 ]

2.  Primary:   Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events   [ Time Frame: Baseline to Week 52 ]

3.  Secondary:   Change in HbA1c From Baseline to Week 52   [ Time Frame: Baseline, Week 52 ]

4.  Secondary:   Percentage of Patients Achieving HbA1c <=7% at Week 52   [ Time Frame: Baseline, Week 52 ]

5.  Secondary:   Percentage of Patients Achieving HbA1c <=6.5% at Week 52   [ Time Frame: Baseline, Week 52 ]

6.  Secondary:   Change in Fasting Serum Glucose From Baseline to Week 52   [ Time Frame: Baseline, Week 52 ]

7.  Secondary:   Change in Body Weight From Baseline to Week 52   [ Time Frame: Baseline, Week 52 ]

8.  Secondary:   Change in Total Cholesterol From Baseline to Week 52   [ Time Frame: Baseline, Week 52 ]

9.  Secondary:   Change in High-density Lipoprotein (HDL) From Baseline to Week 52   [ Time Frame: Baseline, Week 52 ]

10.  Secondary:   Change in Triglycerides From Baseline to Week 52   [ Time Frame: Baseline, Week 52 ]

11.  Secondary:   Change in Blood Pressure From Baseline to Week 52   [ Time Frame: Baseline, Week 52 ]


  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: 1-877-285-4559
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: NCT00753896     History of Changes
Other Study ID Numbers: H8O-MC-GWDC
Study First Received: September 15, 2008
Results First Received: February 14, 2012
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration