| August 24, 2005 |
| July 21, 2009 |
| October 2005 |
| July 2008 (final data collection date for primary outcome measure) |
| Change in ASIiAUC During a Hyperglycemic Clamp Test. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ] |
| *To test the hypothesis that in patients with type 2 diabetes who have not achieved adequate glycemic control with metformin treatment, the addition of exenatide and rosiglitazone will provide superior beta-cell function. |
| Complete list of historical versions of study NCT00135330 on ClinicalTrials.gov Archive Site |
- Change in AUC for Glucose During a Meal Challenge Test (MCT). [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Insulin Sensitivity Index as Measured by M-value. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Insulin AUC in the First Stage From Baseline to Endpoint. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Insulin iAUC From Baseline to Endpoint. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT). [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in AUC for C-peptide During a Meal Challenge Test (MCT). [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT). [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT). [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT). [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in HbA1c [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Fasting Serum Glucose Concentration. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Fasting C-peptide [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Fasting Insulin [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Fasting Proinsulin [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Body Weight [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Fasting Total Cholesterol. [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Fasting HDL Cholesterol [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Fasting LDL Cholesterol [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Fasting Triglycerides [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
- Change in Percent Body Fat During a Meal Challenge Test (MCT) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Change in Body Fat Mass During a Meal Challenge Test (MCT) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Change in Lean Body Mass During a Meal Challenge Test (MCT) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Change in Waist Circumference [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Change in Hip Circumference [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Change in Waist-to-hip Ratio [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Incidence of Hypoglycemia Events [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Hypoglycemia Rate Per 30 Days Per Patient [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Pedal Edema Score [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
|
- *Compare the effects of exenatide, rosiglitazone, and a combination of exenatide and rosiglitazone in subjects with type 2 diabetes treated with metformin on various pharmacodynamic measurements and safety and tolerability.
- *Compare total insulin secretion between the exenatide group, rosiglitazone group, and the exenatide plus rosiglitazone group.
|
| |
| An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus |
| An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin |
This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Diabetes Mellitus, Type 2 |
- Drug: exenatide
- Drug: rosiglitazone
|
| |
| |
| |
| Completed |
| 137 |
| July 2008 |
| July 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- HbA1c of 6.8% to 10.0%, inclusive.
- Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.
Exclusion Criteria:
|
| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00135330 |
| James Malone, MD, Study Director, Eli Lilly and Company |
| H8O-US-GWAY |
| Amylin Pharmaceuticals, Inc. |
| Eli Lilly and Company |
| Study Director: |
James Malone, MD |
Eli Lilly and Company |
|
|
| Amylin Pharmaceuticals, Inc. |
| July 2009 |