Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Rosiglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306644

49653/334

Details and patient eligibility

About

The study investigated the effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes.

Full description

RAS Rosiglitazone and Atherosclerosis Study: A 1 year randomised, double-blind, parallel group, placebo controlled study to evaluate the efficacy of rosiglitazone on the progression of intima-media thickness in the carotid artery in subjects with insulin resistance syndrome and/or type 2 diabetes mellitus

Enrollment: 556 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• insulin resistant syndrome or Type 2 Diabetes.

Exclusion criteria

• Use of >= 2 concomitant oral antihyperglycaemic agents within 3 months of study start.
• Initiation of anti-hypertensive or lipid lowering therapy <= 6 months prior to study start or who increased the dose 3 months prior to study start.
• Unstable or severe angina or congestive heart failure NYHA class i-iv, history of acute myocardial infarction or stroke within last 6 months.
• Any history of surgical intervention in the right carotid artery.
• Clinically significant hepatic disease.
• Creatinine clearance <40ml/min.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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556 participants in 1 patient group

Arm 1

Experimental group

Description:

study drug

Treatment:

Drug: Rosiglitazone