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

The estimated maximum study duration for the first randomized patient will be approximately
204 weeks (± 14 days), with a median follow-up over all patients 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 patients will be followed from randomization until the end of study, which should occur
when the last randomized patient has been followed for approximately 10 months. The actual
end date of the study will be "event driven"and the study will end when there are
approximately 844 positively-adjudicated primary cardiovascular outcome events.

Inclusion criteria:

- Men and women who experienced a spontaneous acute coronary syndrome (ACS) event
[i.e., ST-segment elevation myocardial infarction (STEMI)] or non-ST-segment
elevation myocardial infarction (NSTEMI) or unstable angina (USA)] with a documented
elevation above the normal reference range of a cardiac biomarker (Troponin or
Creatinine Kinase (CK)-MB) and the clinical presentation consistent with an acute
coronary syndrome which leads to admission to an acute care facility, within 180 days
following the ACS event and prior to screening.

- Patients with a history of type 2 diabetes (for patients newly diagnosed, diagnosis
will be based on the World Health Organization (WHO) criteria: i.e., either a 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:

- Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to
screening.

- HbA1c <5.5 % or >11% measured at screening visit.

- Required to use incretin-based agents (eg, Glucagon-like peptide -1(GLP-1) agonists
or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the
doubleblind treatment period.

- Patients who have undergone CABG surgery following the qualifying ACS event.

- Patients who have undergone PCI within 15 days prior to screening.

- Patients 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 (eg,
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
patient's potential participation in a clinical trial.