Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00231387

Purpose

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.

Condition	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus	Drug: rosiglitazone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure Vascular Diseases

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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.

Estimated Enrollment:	60
Study Start Date:	September 2002

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231387

Locations

United Kingdom
GSK Clinical Trials Call Center
London, United Kingdom, W2 1NY

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	BRL-049563/351
Study First Received:	October 3, 2005
Last Updated:	June 14, 2007
ClinicalTrials.gov Identifier:	NCT00231387 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

diabetes rosiglitazone plaque

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009