efficacy and safety of efpeglenatide versus placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise

Conditions: Type 2 Diabetes Mellitus

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

study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.

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.