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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
| Condition: |
Diabetes Mellitus, Type 2 |
| Interventions: |
Drug: exenatide Drug: rosiglitazone |
Baseline Characteristics
| 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. |
| 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
| 1. Primary: | Change in ASIiAUC During a Hyperglycemic Clamp Test. [ 20 weeks ] |
| 2. Secondary: | Change in AUC for Glucose During a Meal Challenge Test (MCT). [ Week 20 ] |
| 3. Secondary: | Change in Insulin Sensitivity Index as Measured by M-value. [ Week 20 ] |
| 4. Secondary: | Change in Insulin AUC in the First Stage From Baseline to Endpoint. [ Week 20 ] |
| 5. Secondary: | Change in Insulin iAUC From Baseline to Endpoint. [ Week 20 ] |
| 6. Secondary: | Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT). [ Week 20 ] |
| 7. Secondary: | Change in AUC for C-peptide During a Meal Challenge Test (MCT). [ Week 20 ] |
| 8. Secondary: | Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT). [ Week 20 ] |
| 9. Secondary: | Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT). [ Week 20 ] |
| 10. Secondary: | Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT). [ Week 20 ] |
| 11. Secondary: | Change in HbA1c [ Week 20 ] |
| 12. Secondary: | Change in Fasting Serum Glucose Concentration. [ Week 20 ] |
| 13. Secondary: | Change in Fasting C-peptide [ Week 20 ] |
| 14. Secondary: | Change in Fasting Insulin [ Week 20 ] |
| 15. Secondary: | Change in Fasting Proinsulin [ Week 20 ] |
| 16. Secondary: | Change in Body Weight [ Week 20 ] |
| 17. Secondary: | Change in Fasting Total Cholesterol. [ Week 20 ] |
| 18. Secondary: | Change in Fasting HDL Cholesterol [ Week 20 ] |
| 19. Secondary: | Change in Fasting LDL Cholesterol [ Week 20 ] |
| 20. Secondary: | Change in Fasting Triglycerides [ Week 20 ] |
| 21. Secondary: | Change in Percent Body Fat During a Meal Challenge Test (MCT) [ 20 weeks ] |
| 22. Secondary: | Change in Body Fat Mass During a Meal Challenge Test (MCT) [ 20 weeks ] |
| 23. Secondary: | Change in Lean Body Mass During a Meal Challenge Test (MCT) [ 20 weeks ] |
| 24. Secondary: | Change in Waist Circumference [ 20 weeks ] |
| 25. Secondary: | Change in Hip Circumference [ 20 weeks ] |
| 26. Secondary: | Change in Waist-to-hip Ratio [ 20 weeks ] |
| 27. Secondary: | Incidence of Hypoglycemia Events [ 20 weeks ] |
| 28. Secondary: | Hypoglycemia Rate Per 30 Days Per Patient [ 20 weeks ] |
| 29. Secondary: | Pedal Edema Score [ 20 weeks ] |
More Information
| 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:
|
| 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. |
| Responsible Party: | Eli Lilly and Company ( James Malone, MD, Study Director ) |
| Study ID Numbers: | H8O-US-GWAY |
| Study First Received: | August 24, 2005 |
| Results First Received: | July 21, 2009 |
| Last Updated: | July 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00135330 History of Changes |
| Health Authority: | United States: Food and Drug Administration |