a study to assess the safety and efficacy of sar425899 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: the primary objective of this study was to assess the dose-response relationship of sar425899 versus placebo in terms of glycemic control as measured by the change in glycosylated hemoglobin (hba1c). secondary objectives: * to assess the effect of sar425899 on body weight. * to assess the safety and immunogenicity profile of sar425899, including assessment of the heart rate (hr) change by electrocardiogram (ecg) and holter monitor. * to assess the proportion of participants achieving predefined hba1c targets of \ =5% and \>=10% body weight loss. * to assess the effect of once daily dosing of sar425899 on additional parameters of glycemic control and lipid metabolism. * to assess the effect of once daily dosing of sar425899 on additional pharmacodynamic (pd) biomarkers. * to assess the pharmacokinetic (pk) profile and parameters of sar425899, inter-individual and inter-occasion variability in pk parameters using a population pk approach.

the total study duration will be approximately 30 weeks, consisting of 3 weeks screening period at the site, a 26 weeks treatment period, and 3 days post treatment follow up period.

Eligibility criteria:
inclusion criteria : * participants with type-2 diabetes mellitus (t2dm) for at least 3 months before the screening visit. * on diet/exercise and/or treatment with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 3 months prior to screening. * signed informed consent. exclusion criteria: * at screening, participant's age \ 80 years. * glycated hemoglobin at screening visit \ 10.0%. * body mass index (bmi) \ 45.0 kg/m\^2. * pregnant or lactating women. * women of childbearing potential (wocbp) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. * diagnosis of type 1 diabetes mellitus. * fasting plasma glucose of \>15 mmol/l (270 mg/dl) measured by the central laboratory at screening (visit 1), and confirmed (\>15 mmol/l \[270 mg/dl\]) by a repeat test before randomization. * treatment with glucose-lowering agents(s) other than metformin, currently or within the 3 months prior to screening. * previous insulin use, except for episode(s) of short-term treatment (≤15 consecutive days) for intercurrent illness or pregnancy, or use of insulin within the last 6 months. * contraindication(s) to metformin use. * contraindication(s) to liraglutide use. * significant change in body weight in the 3 months before screening. * poorly controlled hypertension (a resting systolic blood pressure (sbp) \>160 mm hg and/or diastolic blood pressure (dbp) \>95 mm hg at screening). * history of long qt syndrome and/or qtc more than 450 ms at screening visit. * history of pancreatitis or pancreatectomy. * history of weight loss surgery. * personal or immediate family history of medullary thyroid cancer (mtc) or genetic conditions that predispose to mtc. * any prior exposure to drugs belonging to the class of glucagon-like peptide-1 (glp-1) receptor agonists/glp-1 analogs. * contraindications or known hypersensitivity reaction to glucagon. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.