Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2005-05-31

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.

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Detailed Description

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Conditions

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Non-insulin-dependent Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rosiglitazone

Intervention Type DRUG

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No