Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus

Non-insulin-dependent Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231387
• Other study ID #: BRL-049563/351
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2005
• Last updated: January 20, 2017
• Start date: September 2002
• Est. completion date: May 2005

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Non-insulin-dependent Diabetes Mellitus

Intervention

Drug:
• rosiglitazone

Locations

Country	Name	City	State
United Kingdom	GSK Clinical Trials Call Center	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.