Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina
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.
Diabetes Mellitus, Type 2
Drug: Gliclazide (Comparison drug)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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.|
- Angina status at 3 months
- Pulse wave velocity at 3 months
- Small vessel function at 3 months
- Haemostatic markers at 3 months
- Biochemical markers of inflammation at 3 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225342
|Cardiology Department, Glasgow Royal Infirmary|
|Glasgow, United Kingdom, G4 0SF|
|Principal Investigator:||Naveed Sattar, MBChB PhD||University of Glasgow|
|Principal Investigator:||Stuart M Cobbe, MBChB MD||University of Glasgow|