Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

Exclusion Criteria

• •Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.
• •Glycosylated hemoglobin (HbA1c) \<5.5 % or \>11% measured at screening visit.
• •Required to use incretin-based agents (e.g., Glucagon-like peptide -1 (GLP-1) agonists or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the double-blind treatment period.
• •Participants who had undergone coronary artery bypass graft (CABG) surgery following the qualifying ACS event.
• •Participants who had undergone percutaneous coronary intervention (PCI) within 15 days prior to screening.
• •Participants with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit.
• •History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).
• •Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases.
• •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.