Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus - Tabular View

Tracking Information

First Received Date ^ICMJE

October 3, 2005

Last Updated Date

June 14, 2007

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 52 Weeks ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00231387 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Non-Insulin-Dependent Diabetes Mellitus

Intervention ^ICMJE

Drug: rosiglitazone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00231387

Responsible Party

Study ID Numbers ^ICMJE

BRL-049563/351

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP