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

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
Diabetes Mellitus, Type 2	Drug: Rosiglitazone	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2 Metabolic Syndrome

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

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. [ Time Frame: 52 weeks ]

Secondary Outcome Measures:

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


Enrollment:	556
Study Start Date:	May 2002
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 study drug	Drug: Rosiglitazone study drug

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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	GlaxoSmithKline

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. This link exits the ClinicalTrials.gov site