drugset / Trial / NCT00486187

Effects of ROSIglitazone on Inflammatory Markers and Adipokines in Diabetic Patients Using an Angiotensin Receptor Blocker (TELmisartan) - The ROSITEL Study

NCT00486187

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the ROSITEL study is to assess the effects of rosiglitazone, as compared to standard oral therapies for diabetes (metformin/sulfonylurea), on inflammatory markers and adipokine levels in diabetic patients using an angiotensin receptor blocker (ARB). We hypothesize that ARB-treated diabetic patients receiving rosiglitazone will experience greater reductions in vascular inflammation and levels of leptin and resistin, associated with increased adiponectin levels, compared to a metformin/sulfonylurea regimen, and that these benefits will result in part, from greater improvements in insulin sensitivity in the rosiglitazone group.

Timeline

Start
2006-04
Primary completion
2009-06
Completion
2009-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Glyburide Small molecule 5 mg
Subject Glyburide Small molecule 10 mg
Comparator Metformin Small molecule 500 mg
Comparator Metformin Small molecule 1 g
Subject Rosiglitazone Small molecule 4 mg
Subject Rosiglitazone Small molecule 8 mg