Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus

GlaxoSmithKline60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non-insulin-dependent Diabetes Mellitus

Interventions

rosiglitazoneDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Clinical Trials Call Center

London, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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