Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Non-insulin-dependent Diabetes Mellitus

Treatments

Drug: rosiglitazone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00231387

BRL-049563/351

Details and patient eligibility

About

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.

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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.