Health Condition 1: null- Acute coronary syndrome & Diabetes Health Condition 2: I249- Acute ischemic heart disease, unspecified
Conditions
Interventions
Intervention1: lixisenatide: Titration period (week 0 to 2): 10 �g lixisenatide (0.10 mL injection) once a day in the morning within 1 hour prior to breakfast
Maintenance period (week 2 to 176): 20
g volume-matched placebo ( 0.10 mL injection) once a day in the morning within 1 hour prior to breakfast
Titration period (week 0 to 2): 10 µ
g volume-matched placebo (0.10 mL injection) once a day in the morning within 1 hour prior to breakfast
Maintenance period (week 2 to 176): 20 µ
g volume-matched placebo (0.20 mL injection) once a day in the morning within 1 hour prior to breakfast
Sponsors
SanofiSynthelabo India Limited A Sir Mathuradas Vasanji Road Andheri E Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: 1.Men and women who experienced an ACS event [i.e., ST-segment elevation myocardial infarction (STEMI)] or non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina (UA)], at least 5 days and no more than 12 weeks prior to the screening visit, and providing that they are discharged from the acute care facility (i.e., emergency room, intensive care unit, etc). 2.Patients with a history of type 2 diabetes (for patients newly diagnosed, diagnosis will be based on the WHO criteria: i.e., fasting venous plasma glucose concentration >= 7.0 mmol/L [126 mg/dL] or 2-hour post glucose load venous plasma glucose >= 11.1 mmol/L [200 mg/dL], confirmed on 2 occasions) prior to the screening visit.
Exclusion criteria
Exclusion criteria: For the entry into the run-in period: 1. glycated hemoglobin A1c (HbA1c) 10.0% on last value obtained prior to the screening visit 2. fasting plasma glucose > 13.9 mmol/L ( > 250 mg/dL), on last value obtained prior to the screening visit. 3. patients who have undergone a coronary artery bypass graft surgery (CABG) prior to screening, or a percutaneous intervention (PCI) within 30 days prior to screening or a catheterization within 7 days prior to screening. 4. patients with planned revascularization procedure (PCI or CABG) at the time of screening visit. For the entry into the double-blind treatment period (randomization): 5. HbA1c 10.0% measured at screening visit. 6. fasting plasma glucose > 13.9 mmol/L ( > 250 mg/dL) measured at screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first occurrence of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, adjudicated and validated by the Cardiovascular Events Adjudication Committee (CAC)Timepoint: week 0 to week 176 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1Time to the first occurrence of any of the following clinical events, adjudicated and validated by the CAC: − Cardiovascular death, Non-fatal MI, Non-fatal stroke, Hospitalization for unstable angina, Hospitalization for heart failure, Coronary revascularization procedure. 2 Percent change in the urinary albumin/creatinine ratio from baseline to 108 weeks 3 Other endpoints: - Cardiometabolic markers, Body weight, Adverse events, Anti-lixisenatide antibodies. Timepoint: week 0 to week 176 | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Egypt, Estonia, Finland, France, Germany, Guatemala, India, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States of America
Contacts
Public ContactVaishali Kanade
Sanofi-Synthelabo (I) Ltd
Outcome results
None listed