| Outcome Measures: |
Primary: A composite endpoint including: all-causes mortality, non fatal myocardial infarction (MI) - including silent MI- , non fatal stroke, unplanned coronary revascularization, 48 months | Secondary: 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, 48 months|a composite CV endpoint including the primary endpoint plus heart failure, endovascular or surgical intervention on the coronary, leg or carotid arteries, angina, intermittent claudication with an ankle/brachial index < 0.85, 48 months|glycemic control (changes from baseline in HbA1c, time to failure of oral hypoglycaemic therapy, i.e., HBA1c >8.0% on two consecutive occasions three months apart), 48 months|major cardiovascular risk factors (lipids, blood pressure, microalbuminuria, inflammation markers, waist circumference), 48 months|development of nephropathy: plasma creatinine increase of 2 times above the baseline value or creatinine clearance reduction of 20ml/min/1. 73m2 or development of microalbuminuria or overt nephropathy (dialysis o plasma creatinine >3,3 mg/dl), 48months|events of heart failure evaluated according to the American Heart Association and the American Diabetes Association consensus on glitazones and heart failure, 48 months
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| Locations: |
Ospedale Locatelli di Piario, Seriate, Bergamo, Italy|Hospitaal of Treviglio, Treviglio, Bergamo, Italy|Hospital of Lanciano, Lanciano, Chieti, Italy|Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy|ASL 4 - Chiavarese, Chiavari, Genova, Italy|ASL 64, Eboli, Salerno, Italy|Presidio Ospedaliero Atri, Atri, Teramo, Italy|"Maggiore" Hospital, Chieri, Turin, Italy|Inrca - Irccs, Ancona, Italy|San Donato Hospital, Arezzo, Italy|University of Bari, Bari, Italy|Ospedali Riuniti di Bergamo, Bergamo, Italy|Policlinico S. Orsola Malpigli, Bologna, Italy|Presidio Ospedaliero A.S.RE.Molise, Campobasso, Italy|"Garibaldi di Nesima" Hospital, Catania, Italy|"Mater Domini" University, Catanzaro, Italy|M. Bufalini Hospital, Cesena, Italy|ASP, Cosenza, Italy|Arcispedale "S.Anna", Ferrara, Italy|University of Ferrara, Ferrara, Italy|University of Florence, Florence, Italy|Ospedali Riuniti, Foggia, Italy|University of Genova, Genova, Italy|San Salvatore Hospital, L'Aquila, Italy|ASL Latina, Latina, Italy|Santa Maria Goretti Hospital, Latina, Italy|"Cittadella della Salute" Hospital, Lecce, Italy|ASL 6, Livorno, Italy|Hospital of Massa, Massa Carrara, Italy|Matera Hospital, Matera, Italy|"Ospedali Riuniti Papardo-Piemonte" Hospital, Messina, Italy|University of Messina, Messina, Italy|Istituto Scientifico San Raffaele, Milan, Italy|Niguarda Cà Grande Hospital, Milan, Italy|"Federico II"University of Naples, Naples, 80131, Italy|"Federico II" University, Naples, Italy|Second University, Naples, Italy|Complesso Sociosanitario dei Colli, Padua, Italy|University of Padua, Padua, Italy|University of Palermo, Palermo, Italy|University of Parma, Parma, Italy|University of Perugia, Perugia, Italy|Civil Hospital, Pescara, Italy|Ospedale Gugliemo da Saliceto, Piacenza, Italy|University of Pisa, Pisa, Italy|Spedali Riuniti di Pistoia, Pistoia, Italy|ASP, Potenza, Italy|Praia a Mare Hospital, Praia a Mare, Italy|Operative Unit of Diabetologia - ASL 4, Prato, Italy|University of Ravenna, Ravenna, Italy|Ospedale Infermi, Rimini, Italy|Ospedale Pertini, Roma, Italy|Policlinico di Tor Vergata, Roma, Italy|Sant'Andrea Hospital, Rome, Italy|University of Siena, Siena, Italy|"San Matteo degli Infermi" Hospital, Spoleto, Italy|"Molinette" Hospital, Turin, Italy|Azienda Ospedaliero Universitaria " S.Maria della Misericordia ", Udine, Italy|Hopital of Gallarate, Varese, Italy|"G. Fracastoro" Civil Hospital, Verona, Italy|Civil Hospital, Verona, Italy
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