Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

Clinical Trial ID: NCT03713684

Description

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 basal insulin alone or in combination with oral antidiabetic drugs (OADs). 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.

Study duration per participant is approximately 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension Period, and a 6-week safety Follow-up Period.


Criteria

Inclusion criteria: - Participant must be ≥18 years of age at the time of signing the informed consent. - Participants with type 2 diabetes mellitus (T2DM). - Diabetes diagnosed at least 1 year before screening. - Participants on basal insulin regimen alone or in combination with oral antidiabetic drugs (OADs) for at least 6 months prior to screening. - Glycated hemoglobin (HbA1c) 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. - 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 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 x upper limit of normal (ULN) or total bilirubin >1.5 x ULN (except in case of documented Gilbert's syndrome); - Amylase and/or lipase: >3 x ULN; - 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. - 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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  • Start Date

    2018-11-09

  • Last Updated

    2020-01-23

  • Sponsor

    Sanofi

  • Condition Name

    Type 2 Diabetes Mellitus

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