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 on March 22, 2006. Last Updated on 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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	See Detailed Description

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 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

Intervention Details:

Other Name: Rosiglitazone

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:	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
rosiglitazone
intima media thickness

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Hyperinsulinism
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012