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

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Insulin; Rosiglitazone

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.