Diabetes Mellitus, Type 2
Conditions
Keywords
rosiglitazone, Type 2 diabetes, intima media thickness, Insulin resistance
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 thickness in the carotid artery in subjects with insulin resistance syndrome and/or type 2 diabetes mellitus
Interventions
DRUGRosiglitazone
study drug
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment. | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Plaque occurrence & stenosis within the right carotid artery. | 52 weeks |
Countries
Sweden
Outcome results
None listed