Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: efpeglenatide (SAR439977); placebo
Intervention description: Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Pharmaceutical form: solution for injection
Route of administration: subcutaneous
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: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to
      placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes
      Mellitus) inadequately controlled with diet and exercise.

      Secondary Objectives:

        -  To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison
           to placebo on glycemic control

        -  To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison
           to placebo on body weight

        -  To evaluate the safety of once-weekly injection of efpeglenatide
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants must be at least 18 years of age at the time of signing the informed
             consent.

          -  Participants with T2DM, and treated with diet and exercise.

          -  Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory
             at Screening.

        Exclusion criteria:

          -  Clinically relevant history of gastrointestinal disease associated with prolonged
             nausea and vomiting, including (but not limited to) gastroparesis, unstable and not
             controlled gastroesophageal reflux disease within 6 months prior to Screening or
             history of surgery affecting gastric emptying.

          -  History of pancreatitis (unless pancreatitis was related to gallstone and
             cholecystectomy has been performed) and pancreatitis during previous treatment with
             incretin therapies, chronic pancreatitis, and pancreatectomy.

          -  Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions
             that predisposes to MTC (eg multiple endocrine neoplasia syndromes).

          -  Retinopathy or maculopathy with one of the following treatments, either recent (within
             3 months of screening) or planned: intravitreal injections or laser or vitrectomy
             surgery.

          -  Body weight change of ≥5 kg within the last 3 months prior to Screening.

          -  Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at
             Randomization.

          -  End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by
             Modification of Diet in Renal Disease [MDRD]) of <15 mL/min/1.73 m2.

          -  Laboratory findings at the Screening Visit:

          -  Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) >3 times the
             upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case
             of documented Gilbert's syndrome).

          -  Amylase and/or lipase: >3 times the ULN laboratory range.

          -  Calcitonin ≥5.9 pmol/L (20 pg/mL).

          -  Gastric surgery or other gastric procedures intended for weight loss within 2 years
             prior to Screening, or planned during study period.

          -  History of drug or alcohol abuse within 6 months prior to the time of Screening.

          -  Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.

          -  Women of childbearing potential not willing to use highly effective method(s) of birth
             control during the study period and for at least 5 weeks after the last dose of study
             intervention.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.