Effect of Efpeglenatide on Cardiovascular Outcomes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Efpeglenatide (SAR439977); Placebo
Intervention description: Pharmaceutical form: Solution for injection,
Route of administration: SC; Pharmaceutical form: Solution for injection
Route of administration: SC
Intervention MeSH terms: Efpeglenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4076.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major
      adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high
      cardiovascular (CV) risk.

      Secondary Objectives:

      To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants
      with high CV risk on the following parameters:

        -  3-point MACE.

        -  Expanded CV outcome.

        -  Composite outcome of new or worsening nephropathy.

      To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of
      care in T2DM participants at high CV risk.
    

Eligibility criteria:

        Inclusion criteria:

          -  T2DM with glycosylated hemoglobin (HbA1c) greater than (>) 7 percentage.

          -  Age 18 years or older who met at least one of the cardiovascular disease criteria or
             age 50 years (male), 55 years (female) or older with glomerular filtration rate
             greater than or equal to 25 and less than 60 milliliters per minute and at least had
             one cardiovascular risk factor.

          -  Female participants agreed to follow contraceptive guidance.

          -  Signed written informed consent.

        Exclusion criteria:

          -  Clinically relevant history of gastrointestinal disease associated with prolonged
             nausea and vomiting.

          -  History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any
             type of acute pancreatitis within 3 months prior to screening.

          -  Personal or family history of medullary thyroid cancer.

          -  Hypertension (with a systolic blood pressure >180 millimeters of Mercury [mmHg] and/or
             diastolic blood pressure >100 mmHg).

          -  Hospitalization for hypertensive emergency within 3 months prior to randomization.

          -  Planned coronary procedure or surgery after randomization.

          -  No documented ophthalmologic exam with fundoscopy within 6 months prior to
             randomization.

          -  Retinopathy or maculopathy with treatment, either recent (3 months prior to
             randomization) or planned during the study.

          -  Treated with any glucagon-like peptide-1 receptor agonist product alone (eg,
             exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in
             combination within 3 months prior to screening.

          -  Use of any Dipeptidyl peptidase 4 inhibitor within 3 months prior to screening.

          -  Antihyperglycemic treatment had not been stable within 3 months prior to screening.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.