Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina
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|ClinicalTrials.gov Identifier: NCT00225342|
Recruitment Status : Withdrawn
First Posted : September 23, 2005
Last Update Posted : September 8, 2006
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 or disease||Intervention/treatment||Phase|
|Angina Pectoris Diabetes Mellitus, Type 2||Drug: Rosiglitazone Drug: Gliclazide (Comparison drug)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|