Status:
COMPLETED
Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35-80 years
Phase:
PHASE4
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.
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT00306644
Start Date
May 1 2002
End Date
November 1 2004
Last Update
September 1 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Malmo, Sweden, SE-205 02