Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-insulin-dependent Diabetes Mellitus

Intervention / Treatment
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* Drug: rosiglitazone


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Type 2 diabetes. Co-existing vascular disease. At least 6 months of statin or fibrate therapy. HbA1c <10% at screening and with at least one atheromatous plaque causing 10-95% narrowing of the internal carotid artery. Exclusion criteria: Patients with >2 concomitant oral anti-hyperglycaemic agents within 3 months of screening. Previous exposure to a thiazolidinedione. History of chronic insulin use. Use of investigational drug within 30 days. Systolic blood pressure (bp) > 170 mmHg or diastolic bp >100 mmHg. Severe or unstable angina. History of: gangrene, TIA, stroke, hepatic disease, alcohol or drug abuse, surgery of the carotid arteries or claustrophobia.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rosiglitazone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes rosiglitazone plaque