drugset / Trial / NCT00318656
24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
A better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride).
Timeline
- Start
- 2005-11
- Primary completion
- 2007-10
- Completion
- 2007-10
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Avandamet® (Rosiglitazone/Metformin) vs Glimepiride/Metformin; p = 0.064; Mean Difference (Net) 5.02 (95% CI -0.32 to 10.36); ANCOVA NCT00318656 ↗
registry analysis (superiority or other test); Avandamet® (Rosiglitazone/Metformin) vs Glimepiride/Metformin; p = 0.923; Mean Difference (Net) -0.26 (95% CI -3.37 to 2.85); ANCOVA NCT00318656 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glimepiride | Small molecule | — | — |
| Subject | Rosiglitazone | Small molecule | — | — |
| Background | Metformin | Small molecule | — | — |