Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

Inclusion criteria : * Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be biguanide, thiazolidinedione, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor. * Signed written informed consent. Exclusion criteria: * At the screening visit: age \<20 years. * At the screening visit: HbA1c \<7.5% or \>10%. * At the screening visit: fasting plasma glucose (FPG) \>250 mg/dL (13.8 mmol/L). * Pregnancy or lactation, women of childbearing potential with no effective contraceptive method. * Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria during the 3 months before the screening visit. * Previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician). * Laboratory findings at the screening visit, including: * Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN), * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ULN, * Calcitonin ≥20 pg/mL (5.9 pmol/L), * Positive serum pregnancy test. * Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any glucagon-like peptide-1 receptor agonist (GLP-1RA) or to metacresol. * Contraindication to use of insulin glargine according to the local labeling. History of hypersensitivity to insulin glargine or to any of the excipients. * Patient who has a severe renal function impairment with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2 or end-stage renal disease for patient not treated with metformin. * Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes). * History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.