Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Efpeglenatide SAR439977; Placebo; Background therapy: Metformin alone or in combination with SU
Intervention description: Pharmaceutical form: solution for injection Route of administration: subcutaneous; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling.
Intervention MeSH terms: Metformin; 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: 312.0
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 type 2 diabetes mellitus
      (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU).

      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:

          -  Participant must be greater than or equal to (>=)18 years of age at the time of
             signing the informed consent.

          -  Participants with T2DM.

          -  Diabetes diagnosed at least 1 year before screening.

          -  Participants on metformin alone or in combination with SU, for at least 3 months prior
             to screening.

          -  Glycated hemoglobin between 7.0% and 10.0% (inclusive) measured by the central
             laboratory at screening.

        Exclusion criteria:

          -  History of severe hypoglycemia requiring emergency room admission or hospitalization
             within 3 months prior to screening.

          -  Retinopathy or maculopathy with one of the following treatments, either recent (within
             3 months prior to screening) or planned: intravitreal injections or laser or
             vitrectomy surgery.

          -  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 requiring medical treatment within 6 months
             prior to screening or history of surgery affecting gastric emptying.

          -  History of pancreatitis (unless pancreatitis was related to gallstones and
             cholecystectomy has been performed), pancreatitis during previous treatment with
             incretin therapies, chronic pancreatitis, pancreatectomy.

          -  Personal or family history of medullary thyroid cancer (MTC) or genetic conditions
             that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).

          -  Body weight change of >=5 kilograms within the last 3 months prior to screening.

          -  Systolic blood pressure greater than (>)180 millimeters of mercury (mmHg) and/or
             diastolic blood pressure >100 mmHg at randomization.

          -  Severe renal disease as defined by estimated glomerular filtration rate (eGFR) of <30
             milliliters per minute per 1.73 square meter.

          -  Laboratory findings at the screening visit:

               -  Alanine aminotransferase or aspartate aminotransferase >3*upper limit of the
                  normal (ULN) or total bilirubin >1.5*ULN (except in case of documented Gilbert's
                  syndrome);

               -  Amylase and/or lipase: >3*ULN laboratory range;

               -  Calcitonin >=5.9 picomoles per liter (20 picograms per milliliter).

          -  Gastric surgery or other gastric procedures intended for weight loss within 2 years
             prior to screening, or planned during study period.

          -  Pregnant (confirmed 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 or who are unwilling to be tested for pregnancy during the study period and
             for at least 5 weeks after the last dose of study intervention.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.