drugset / Trial / NCT00486187
Effects of ROSIglitazone on Inflammatory Markers and Adipokines in Diabetic Patients Using an Angiotensin Receptor Blocker (TELmisartan) - The ROSITEL Study
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
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |