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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 22, 2006
Last updated: October 13, 2008
Last verified: October 2008
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.

Condition Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
Drug: Rosiglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Plaque occurrence & stenosis within the right carotid artery.

Estimated Enrollment: 556
Study Start Date: May 2002
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

Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00306644

GSK Investigational Site
Malmö, Sweden, SE-205 02
Sponsors and Collaborators
Study Director: GSK Clinical Trials, DM, FRCP GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00306644     History of Changes
Other Study ID Numbers: 49653/334 
Study First Received: March 22, 2006
Last Updated: October 13, 2008
Health Authority: Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
Insulin resistance
Type 2 diabetes
intima media thickness

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016