Rosiglitazone And Plaque Study for Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00231387
First received: October 3, 2005
Last updated: June 14, 2007
Last verified: June 2007
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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:
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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00231387 History of Changes |
| Other Study ID Numbers: | BRL-049563/351 |
| Study First Received: | October 3, 2005 |
| Last Updated: | June 14, 2007 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
|
diabetes rosiglitazone plaque |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013