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Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina

2014-08-27 03:48:44 | BioPortfolio

Summary

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.

Description

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Angina Pectoris

Intervention

Rosiglitazone, Gliclazide (Comparison drug)

Location

Cardiology Department, Glasgow Royal Infirmary
Glasgow
United Kingdom
G4 0SF

Status

Withdrawn

Source

University of Glasgow

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:48:44-0400

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A cardioselective beta-1-adrenergic blocker. It is effective in the management of hypertension and angina pectoris.

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