EUCTR2008-000738-39-IT进行中（未招募）不适用
EFFECTS ON INCIDENCE OF CARDIOVASCULAR EVENTS OF THE ADDITION OF PIOGLITAZONE AS COMPARED WITH A SULFONYLUREA IN TYPE 2 DIABETIC PATIENTS INADEQUATELYCONTROLLED WITH METFORMINThiazolidinediones Or Sulphonylureas and Cardiovascular Accidents (TOSCA) - TOSCA Study
Societa' Italiana di Diabetologia0 个研究点开始时间: 2008年7月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients with type 2 diabetes (WHO criteria) of at least 2 years duration
- •-Males and females
- •-Age 50-75 years
- •-BMI 20-40 Kg/m2
- •-Stable treatment for the last three months with metformin in monotherapy
- •-Glycated haemoglobin (HbA1c) >7.0% and <9.0%
- •-Potentially childbearing women must use a reliable contraceptive method
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Type 1 diabetes
- •-Previous or current use of insulin (if not on pregnancy or for surgery or for intercurrent acute illness).
- •-Current use of glucose lowering therapies other than metformin
- •-Contraindication/intolerance to metformin or sulphonylureas or thiazolidinediones
- •-Chronic use of glucocorticoids
- •-Documented coronary or cerebrovascular events in the previous 6 months
- •-Serum creatinine >1.5 mg/dl
- •-Proliferative retinopathy
- •-Ischemic ulcer or gangrene
- •-History of congestive heart failure, NYHA (New York Heart Association ) class I or higher
- •-Liver cirrhosis or severe hepatic dysfunction (2.5 times the upper limit of normal concentration of alanine aminotransferase)
- •-Pregnancy or breast feeding
- •-Cancer, substance abuse, any health problem that may interfere with the compliance to study protocol or limit life expectancy
研究者
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