A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

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 \<7% and \<6.5% as well as the proportion of participants achieving \>=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 \< legal age of adulthood and \>80 years.
* Glycated hemoglobin at screening visit \<7.0% or \>10.0%.
* Body mass index (BMI) \<25 kg/m\^2 or \>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.