Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
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 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This is a phase IIIb, randomised, double blind, placebo controlled, study in patients with
type 2 diabetes mellitus and coexisting vascular disease or hypertension. The total duration
of the study will be approximately 60 weeks. The aim of this study is to examine the
potential beneficial effects of rosiglitazone on carotid atheroma in patients with type 2
diabetes mellitus and coexisting vascular disease or hypertension. It is hypothesised that
treatment with rosiglitazone will lead to an decrease in plaque size. In addition, it is
hoped that rosiglitazone will have a positive effect on plaque composition and stability.
Clinical Details
Official title: Rosiglitazone and Plaque Study: A 12 Month Randomised, Double-Blind, Placebo-Controlled, Magnetic Resonance Imaging Study to Evaluate the Effect of Rosiglitazone on the Structure and Composition of Carotid Atherosclerotic Plaques in Subjects With Type 2 Diabetes Mellitus and Coexisting Vascular Disease or Hypertension
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The effect of 52 wks oral treatment with rosiglitazone in comparison to placebo on change from baseline of the plaque total wall volume in the carotid artery, in patients with type 2 dm and vascular disease/hypertension, using cardiac mri.
Secondary outcome: These include magnetic resonance endpoints related to plaque lipid content, volume, plaque size and fibrous cap thickness. Colour duplex measurements, laboratory assays for glycaemia and lipids.
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Type 2 diabetes.
- Co-existing vascular disease.
- At least 6 months of statin or fibrate therapy.
- HbA1c <10% at screening and with at least one atheromatous plaque causing 10-95%
narrowing of the internal carotid artery.
Exclusion criteria:
- Patients with >2 concomitant oral anti-hyperglycaemic agents within 3 months of
screening.
- Previous exposure to a thiazolidinedione.
- History of chronic insulin use.
- Use of investigational drug within 30 days.
- Systolic blood pressure (bp) > 170 mmHg or diastolic bp >100 mmHg.
- Severe or unstable angina.
- History of: gangrene, TIA, stroke, hepatic disease, alcohol or drug abuse, surgery of
the carotid arteries or claustrophobia.
Locations and Contacts
GSK Clinical Trials Call Center, London W2 1NY, United Kingdom
Additional Information
Starting date: September 2002
Last updated: June 14, 2007
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