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

GlaxoSmithKline556 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

556

Conditions

Diabetes Mellitus, Type 2

Interventions

RosiglitazoneDRUG

study drug

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Malmo, Sweden

Outcomes

Primary Outcomes

Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.

Time frame: 52 weeks

Secondary Outcomes

Plaque occurrence & stenosis within the right carotid artery.

Time frame: 52 weeks

Data from ClinicalTrials.gov

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