diabetes mellitus MedDRA version: 9.1 Level: HLT Classification code 10012654 Term: Diabetic complications cardiovascular MedDRA version: 9.1 Level: HLT Classification code 10012658 Term: Diabetic complications renal
Conditions
Interventions
Product Name: Pioglitazone
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Product Name: Glibencl
Sponsors
Societa' Italiana di Diabetologia
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our aim is to ascertain whether in patients with type 2 diabetes poorly controlled with the maximal tolerated dose of metformin, the addition of pioglitazone reduces the rate of cardiovascular events as compared with the addition of a SU. Glucose control, major CV risk factors, safety, tolerability and economic costs with the two therapeutic regimens will also be compared. Sample size and study power are calculated on the primary efficacy outcome.;Secondary Objective: PRINCIPAL secondary outcome: - A composite ischemic end point of: sudden death, fatal and non fatal MI (including silent MI), fatal and non fatal stroke, major leg amputation (above the ankle), endovascular or surgical interventions on the coronary, leg or carotid arteries OTHER secondary outcomes: - a composite cardiovascular endpoint including the primary endpoint plus heart failure - by the full version of the Boston criteria - endovascular or surgical intervention on the coronary, leg or carotid arteries, angina - by WHO criteria and confirmed by a new electrocardiogram abnormalities - intermittent claudication with an ankle/brachial index 8.0% on two consecutive occasions three months apart); - major cardiovascular risk factors (lipids, blood pressure, microalbuminuria, inflammation markers, waist circumference); - a microvascular composite e;Primary end point(s): A composite endpoint including: all-causes mortality, non fatal myocardial infarction (MI) - including silent MI- , non fatal stroke, unplanned coronary revascularization | — |
Countries
Italy
Outcome results
None listed