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.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Angina status at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic stable angina with ongoing symptoms. (The treatment goal being an improvement in symptoms)
- •Participants will have uncontrolled diabetes (Hba1c>7.5) on metformin monotherapy (so the diabetes is not over treated)
- •Participants will be diabetic for less than 8 years.
排除标准
- •Renal impairment (creatinine >130mmol/l)
- •Hepatic Impairment (ALT>70U/l, AST>80U/l)
- •Any clinical signs of heart failure
- •Physical disability precluding treadmill exercise tolerance testing
- •Abnormal resting ECG (left or right bundle-branch block, left or right ventricular hypertrophy, ventricular preexcitation, Q-wave myocardial infarction, digitalis therapy)
- •Women of childbearing potential
- •Women who are breastfeeding
结局指标
主要结局
Angina status at 3 months
次要结局
- Small vessel function at 3 months
- Biochemical markers of inflammation at 3 months
- Pulse wave velocity at 3 months
- Haemostatic markers at 3 months