Back to resultsRosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
Primary Purpose
Non-insulin-dependent Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
rosiglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Non-insulin-dependent Diabetes Mellitus focused on measuring diabetes rosiglitazone plaque
Eligibility 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.
Sites / Locations
- GSK Clinical Trials Call Center
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00231387
Brief Title
Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2002 (Actual)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-insulin-dependent Diabetes Mellitus
Keywords
diabetes rosiglitazone plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rosiglitazone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
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