NCT00231387

Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-insulin-dependent Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	rosiglitazone

Timeline

• Start date: 2002-09-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2005-10-04
• Last updated: 2017-01-23

Locations

1 site across 1 country: United Kingdom