Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Efpeglenatide; Dulaglutide; Background therapy Metformin
Intervention description: Pharmaceutical form: solution for injection; Route of administration: SC; Pharmaceutical form: solution for injection; Route of administration: SC; Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.
Intervention MeSH terms: Metformin; Dulaglutide; Efpeglenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: The study was open-label for the tested versus comparator drug and double blind for the doses.
Enrollment: 908.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to
      once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants
      with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.

      Secondary Objectives:

        -  To demonstrate the superiority of once weekly injection of efpeglenatide with once
           weekly injection of dulaglutide on glycemic control.

        -  To demonstrate the superiority of once weekly injection of efpeglenatide with once
           weekly injection of dulaglutide on body weight.

        -  To evaluate the safety of once weekly injection of efpeglenatide and once weekly
           injection of dulaglutide.
    

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 stable dose of at least 1500 milligram per day (mg/day) of metformin,
             or tolerated maximum dose, or as per country regulation if less, for at least 3 months
             prior to screening.

          -  HbA1c between 7.0 percent (%) and 10.0% (inclusive) measured by the central laboratory
             at screening.

        Exclusion criteria:

          -  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 (GI) 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 had 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 predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).

          -  Body weight change of greater than or equal to (>=) 5 kilogram within the last 3
             months prior to screening.

          -  Systolic blood pressure greater than (>)180 millimeter of mercury (mmHg) and/or
             diastolic blood pressure >100 mmHg at randomization.

          -  Severe renal disease as defined by estimated glomerular filtration rate (eGFR), by
             Modification of Diet in Renal Disease (MDRD)] of less than (<)30 mL/min/1.73 m^2.

          -  Laboratory findings at the screening visit:

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 * upper limit of
             normal (ULN) or total bilirubin >1.5 * ULN (except in case of documented Gilbert's
             syndrome);

          -  Amylase and/or lipase: >3 * ULN;

          -  Calcitonin >=5.9 picomoles per liter (pmol/L) (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 (WOCBP) 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.