Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00231387

Enrollment

Registered

2005-10-04

Start date

2002-09-30

Completion date

2005-05-31

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-insulin-dependent Diabetes Mellitus

Keywords

diabetes rosiglitazone plaque

Brief 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.

Interventions

DRUGrosiglitazone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	52 Weeks

Secondary

Measure	Time frame
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.	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026