Primary Objective: \- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event. Secondary Objectives: To demonstrate that when compared to placebo, lixisenatide can reduce: * composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure. * composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. * urinary albumin excretion (based on the urinary albumin/creatinine ratio). To assess the safety and tolerability of lixisenatide.
The estimated maximum study duration for the first randomized participant was approximately 204 weeks (± 14 days), with a median follow-up over all participants of approximately 91 weeks, broken down as follows: * placebo-run-in period: 7 days (+ 3 days) * double-blind study treatment period: 203 weeks (± 14 days) (with about a 37 months of recruitment period) * post-treatment follow-up period: 3 days (± 1 day) All participants were followed from randomization until the end of study, which should occur when the last randomized participant had been followed for approximately 10 months. The actual end date of the study was "event driven" and the study end when there were approximately 844 positively-adjudicated primary cardiovascular outcome events.
Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.
Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.
Adrogué, Argentina
Bahía Blanca, Argentina
Bahía Blanca, Argentina
Bahía Blanca, Argentina
Caba, Argentina
Caba, Argentina
Caba, Argentina
Caba, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Cipolletti, Argentina
Ciudad Autonoma de Bs.As, Argentina
Coronel Suárez, Argentina
Corrientes, Argentina
Corrientes, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Godoy Cruz, Argentina
Haedo, Argentina
Junín, Argentina
La Plata, Argentina
Lanús, Argentina
Mar del Plata, Argentina
Mar del Plata, Argentina
Mendoza, Argentina
Morón, Argentina
Paraná, Argentina
Qilmes, Argentina
Rafaela, Argentina
Ramos Mejía, Argentina
Resistencia, Argentina
Rosario, Argentina
Rosario, Argentina
Salta, Argentina
Salta, Argentina
San Miguel de Tucumán, Argentina
San Miguel de Tucumán, Argentina
San Nicolás, Argentina
Santa Fe, Argentina
Santa Fe, Argentina
Santa Rosa, Argentina
Venado Tuerto, Argentina
Villa María, Argentina
Zárate, Argentina