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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00135330
Recruitment Status : Completed
First Posted : August 26, 2005
Results First Posted : August 28, 2009
Last Update Posted : April 7, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: exenatide
Drug: rosiglitazone

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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.


  More Information

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: Peter Ohman, Medical Science Director
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00135330     History of Changes
Other Study ID Numbers: H8O-US-GWAY
First Submitted: August 24, 2005
First Posted: August 26, 2005
Results First Submitted: July 21, 2009
Results First Posted: August 28, 2009
Last Update Posted: April 7, 2015