Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus
Intervention: Rosiglitazone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trial, DM, FRCP, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: 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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.
Secondary outcome: Plaque occurrence & stenosis within the right carotid artery.
Eligibility
Minimum age: 35 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Malmo SE-205 02, Sweden
Additional Information
Starting date: May 2002
Last updated: March 22, 2006
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