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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00306644
First received: March 22, 2006
Last updated: October 13, 2008
Last verified: October 2008
  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 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
Intervention Details:
    Drug: Rosiglitazone
    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
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, 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
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014