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

Conditions: diabetes mellitus
MedDRA version: 9.1Level: HLTClassification code 10012654Term: Diabetic complications cardiovascular
MedDRA version: 9.1Level: HLTClassification code 10012658Term: Diabetic complications renal

Registration Number: EUCTR2008-000738-39-IT

Lead Sponsor: Societa' Italiana di Diabetologia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

-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