An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00135330
First received: August 24, 2005
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: July 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: exenatide
Drug: rosiglitazone

  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
Enrollment occurred between 18 October 2005 and 14 March 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Exenatide Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.

Participant Flow:   Overall Study
    Exenatide     Exenatide Plus Rosiglitazone     Rosiglitazone  
STARTED     45     47     45  
COMPLETED     33     34     34  
NOT COMPLETED     12     13     11  
Adverse Event                 2                 5                 1  
Lost to Follow-up                 0                 2                 3  
Physician Decision                 1                 1                 0  
Protocol Violation                 4                 3                 3  
Patient Decision                 5                 1                 4  
Sponsor Decision                 0                 1                 0  



  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 Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
Exenatide Plus Rosiglitazone Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
Rosiglitazone Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
Total Total of all reporting groups

Baseline Measures
    Exenatide     Exenatide Plus Rosiglitazone     Rosiglitazone     Total  
Number of Participants  
[units: participants]
  45     47     45     137  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     36     37     36     109  
>=65 years     9     10     9     28  
Age  
[units: years]
Mean ± Standard Deviation
  56.99  ± 9.71     54.63  ± 9.91     55.54  ± 10.71     55.70  ± 10.09  
Gender  
[units: participants]
       
Female     22     25     20     67  
Male     23     22     25     70  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in ASIiAUC During a Hyperglycemic Clamp Test.   [ Time Frame: 20 weeks ]

2.  Secondary:   Change in AUC for Glucose During a Meal Challenge Test (MCT).   [ Time Frame: Week 20 ]

3.  Secondary:   Change in Insulin Sensitivity Index as Measured by M-value.   [ Time Frame: Week 20 ]

4.  Secondary:   Change in Insulin AUC in the First Stage From Baseline to Endpoint.   [ Time Frame: Week 20 ]

5.  Secondary:   Change in Insulin iAUC From Baseline to Endpoint.   [ Time Frame: Week 20 ]

6.  Secondary:   Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).   [ Time Frame: Week 20 ]

7.  Secondary:   Change in AUC for C-peptide During a Meal Challenge Test (MCT).   [ Time Frame: Week 20 ]

8.  Secondary:   Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).   [ Time Frame: Week 20 ]

9.  Secondary:   Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).   [ Time Frame: Week 20 ]

10.  Secondary:   Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).   [ Time Frame: Week 20 ]

11.  Secondary:   Change in HbA1c   [ Time Frame: Week 20 ]

12.  Secondary:   Change in Fasting Serum Glucose Concentration.   [ Time Frame: Week 20 ]

13.  Secondary:   Change in Fasting C-peptide   [ Time Frame: Week 20 ]

14.  Secondary:   Change in Fasting Insulin   [ Time Frame: Week 20 ]

15.  Secondary:   Change in Fasting Proinsulin   [ Time Frame: Week 20 ]

16.  Secondary:   Change in Body Weight   [ Time Frame: Week 20 ]

17.  Secondary:   Change in Fasting Total Cholesterol.   [ Time Frame: Week 20 ]

18.  Secondary:   Change in Fasting HDL Cholesterol   [ Time Frame: Week 20 ]

19.  Secondary:   Change in Fasting LDL Cholesterol   [ Time Frame: Week 20 ]

20.  Secondary:   Change in Fasting Triglycerides   [ Time Frame: Week 20 ]

21.  Secondary:   Change in Percent Body Fat During a Meal Challenge Test (MCT)   [ Time Frame: 20 weeks ]

22.  Secondary:   Change in Body Fat Mass During a Meal Challenge Test (MCT)   [ Time Frame: 20 weeks ]

23.  Secondary:   Change in Lean Body Mass During a Meal Challenge Test (MCT)   [ Time Frame: 20 weeks ]

24.  Secondary:   Change in Waist Circumference   [ Time Frame: 20 weeks ]

25.  Secondary:   Change in Hip Circumference   [ Time Frame: 20 weeks ]

26.  Secondary:   Change in Waist-to-hip Ratio   [ Time Frame: 20 weeks ]

27.  Secondary:   Incidence of Hypoglycemia Events   [ Time Frame: 20 weeks ]

28.  Secondary:   Hypoglycemia Rate Per 30 Days Per Patient   [ Time Frame: 20 weeks ]

29.  Secondary:   Pedal Edema Score   [ Time Frame: 20 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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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 AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00135330     History of Changes
Other Study ID Numbers: H8O-US-GWAY
Study First Received: August 24, 2005
Results First Received: July 21, 2009
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration