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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: Rosiglitazone	Phase 4

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	556 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Effect of Rosiglitazone and Placebo on Carotid Intima Media Thickness in Patients With Insulin Resistance Syndrome and/or Type 2 Diabetes
Study Start Date :	May 2002
Actual Primary Completion Date :	November 2004
Actual Study Completion Date :	November 2004

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Arm 1; study drug	Drug: Rosiglitazone; study drug

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment. [ Time Frame: 52 weeks ]

Secondary Outcome Measures :

1. Plaque occurrence & stenosis within the right carotid artery. [ Time Frame: 52 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	35 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Clinical Study Report 

Identifier: 49653/334
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 49653/334
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 49653/334
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 49653/334
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 49653/334
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 49653/334
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 49653/334
For additional information about this study please refer to the GSK Clinical Study Register

Publications of Results:

Hedblad B, Zambanini A, Nilsson P, Janzon L, Berglund G. Rosiglitazone and carotid IMT progression rate in a mixed cohort of patients with type 2 diabetes and the insulin resistance syndrome: main results from the Rosiglitazone Atherosclerosis Study. J Intern Med. 2007 Mar;261(3):293-305.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00306644 History of Changes
Other Study ID Numbers:	49653/334
First Posted:	March 24, 2006
Last Update Posted:	September 1, 2016
Last Verified:	August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

rosiglitazone; Type 2 diabetes; intima media thickness; Insulin resistance

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Syndrome X; Glucose Metabolism Disorders; Metabolic Diseases	Insulin; Endocrine System Diseases; Hyperinsulinism; Rosiglitazone; Hypoglycemic Agents; Physiological Effects of Drugs