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

This study has been completed.

First Received: March 22, 2006 Last Updated: October 13, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00306644

Purpose

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Metabolic Syndrome

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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

Locations

Sweden
GSK Investigational Site
MALMÖ, Sweden, SE-205 02

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, DM, FRCP

GlaxoSmithKline

More Information

No publications provided

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

Keywords provided by GlaxoSmithKline:

Insulin resistance
Type 2 diabetes
rosiglitazone
intima media thickness

Additional relevant MeSH terms:

Hyperinsulinism
Hypoglycemic Agents
Metabolic Diseases
Metabolic Syndrome X
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Insulin Resistance
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010