Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
This is a phase IIIb, randomised, double blind, placebo controlled, study in patients with type 2 diabetes mellitus and coexisting vascular disease or hypertension. The total duration of the study will be approximately 60 weeks. The aim of this study is to examine the potential beneficial effects of rosiglitazone on carotid atheroma in patients with type 2 diabetes mellitus and coexisting vascular disease or hypertension. It is hypothesised that treatment with rosiglitazone will lead to an decrease in plaque size. In addition, it is hoped that rosiglitazone will have a positive effect on plaque composition and stability.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Rosiglitazone and Plaque Study: A 12 Month Randomised, Double-Blind, Placebo-Controlled, Magnetic Resonance Imaging Study to Evaluate the Effect of Rosiglitazone on the Structure and Composition of Carotid Atherosclerotic Plaques in Subjects With Type 2 Diabetes Mellitus and Coexisting Vascular Disease or Hypertension|
- The effect of 52 wks oral treatment with rosiglitazone in comparison to placebo on change from baseline of the plaque total wall volume in the carotid artery, in patients with type 2 dm and vascular disease/hypertension, using cardiac mri. [ Time Frame: 52 Weeks ]
- These include magnetic resonance endpoints related to plaque lipid content, volume, plaque size and fibrous cap thickness. Colour duplex measurements, laboratory assays for glycaemia and lipids.
|Study Start Date:||September 2002|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231387
|GSK Clinical Trials Call Center|
|London, United Kingdom, W2 1NY|
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|