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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Rosiglitazone

• Registration Number: NCT00306644
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2006-03-22
• Study First Submitted QC: 2006-03-22
• Study First Posted: 2006-03-24
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Rosiglitazone	study drug

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plaque occurrence & stenosis within the right carotid artery.	52 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Malmö, Sweden