drugset / Trial / NCT00318656

24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes

NCT00318656 ↗

Phase 4 Completed 23 enrolled GlaxoSmithKline
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

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule — —
Subject Rosiglitazone Small molecule — —
Background Metformin Small molecule — —