Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Lixisenatide (AVE0010); Placebo
Intervention description: 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.
Intervention MeSH terms: Lixisenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 6068.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion criteria:

          -  Men and women who experienced a spontaneous ACS event (i.e., ST-segment elevation
             myocardial infarction (STEMI) or non-ST-segment elevation MI (NSTEMI) or unstable
             angina) 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 ACS which lead to admission to an acute care facility, within 180
             days following the ACS event and prior to screening.

          -  Participants with a history of type 2 diabetes (for participants newly diagnosed,
             diagnosis was 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.

          -  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.