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Sponsors and Collaborators: |
University of Glasgow GlaxoSmithKline |
Information provided by: | University of Glasgow |
ClinicalTrials.gov Identifier: | NCT00225342 |
The principle objective of the trial is to compare rosiglitazone to gliclazide in patients with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina status changes.
Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina quality of life questionnaire.
Condition | Intervention | Phase |
Angina Pectoris Diabetes Mellitus, Type 2 |
Drug: Rosiglitazone Drug: Gliclazide (Comparison drug) |
Phase IV |
MedlinePlus related topics: | Angina Diabetes |
ChemIDplus related topics: | Rosiglitazone Rosiglitazone Maleate Gliclazide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Rosiglitazone and Sulphonylureas on Ischaemic Burden, Blood Pressure and Novel Risk Markers Inclusive of Vascular Function in Patients With Chronic Stable Angina and Type 2 Diabetes Mellitus: A Randomised, Double-Blinded Study. |
Estimated Enrollment: | 60 |
Ischaemic heart disease is one of the main complications of type 2 diabetes mellitus, both in terms of morbidity and mortality. Reducing plasma glucose with hypoglycaemic agents has not been shown to improve cardiovascular mortality or morbidity. Chronic stable angina is a common problem in patients with type 2 diabetes mellitus.
We postulate that in subjects with uncontrolled type 2 diabetes mellitus (Hba1c >7.5%), on metformin therapy, and chronic stable angina that the addition of the insulin sensitiser, rosiglitazone to control their diabetes will improve their angina when compared to the addition of the hypoglycaemic agent gliclazide. This hypothesis is based on the fact that insulin resistance is an upstream mechanism common to both conditions.
We will randomise such patients to 3 months therapy of rosiglitazone or gliclazide for 3 months, comparing angina status before and after by way of full Bruce protocol exercise testing, 24 hour ST segment analysis and angina questionnaire.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |||||
Cardiology Department, Glasgow Royal Infirmary | |||||
Glasgow, United Kingdom, G4 0SF |
University of Glasgow |
GlaxoSmithKline |
Principal Investigator: | Naveed Sattar, MBChB PhD | University of Glasgow |
Principal Investigator: | Stuart M Cobbe, MBChB MD | University of Glasgow |
Study ID Numbers: | GlasUniRosiGlic, Eudract No. 2004-000943-40 |
First Received: | September 21, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00225342 |
Health Authority: | United Kingdom: National Health Service |
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