Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

Inclusion criteria : * Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and treated with basal insulin for at least 6 months before screening visit (V1). * Patients who have been treated with a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before screening visit (V1). * Stable total daily basal insulin dose (±20 %) in the range of 10 and 25 U/day for at least 2 months before screening visit (V1). Total daily dose should be within the range of 10-25 U, both inclusive, on the day of screening, but individual fluctuations of ±20% within 2 months prior to screening are acceptable. * For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months prior to screening. The OAD(s) can be 1 to 2 out of: * Metformin (≥1500 mg/day or maximal tolerated dose). * Sulfonylurea (SU)/glinide. * Alpha-glucosidase inhibitor (alpha-GI). * Sodium-glucose co-transporter 2 (SGLT2) inhibitor. * Dipeptidyl-peptidase-4 (DPP-4) inhibitor. * Fasting plasma glucose (FPG) ≤160 mg/dL (8.9 mmol/L) at screening visit (V1) (can be repeated once to confirm). * Signed written informed consent. Exclusion criteria: * Age \<18 years at screening visit (V1). * Screening glycated hemoglobin A1c(HbA1c) \<7.0% or \>10.5%. * History of hypoglycemia unawareness. * History of metabolic acidosis, including diabetic ketoacidosis within one year prior to screening. * Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening. * Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin, within one year prior to screening (Note: Short term treatment \[≤10 days\] due to intercurrent illness is allowed). * History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reason or lack of efficacy. * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening. * Use of weight loss drugs within 3 months prior to screening. * Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening. * Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. * Planned coronary, carotid, or peripheral revascularization procedures to be performed during the study period. * Known history of drug or alcohol abuse within 6 months prior to screening. * Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg. * Laboratory findings at screening visit: * Amylase and/or lipase \>3 times the upper limit of normal (ULN) laboratory range. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ULN. * Total bilirubin \>1.5 ULN (except in case of Gilbert's syndrome). * Calcitonin ≥20 pg/mL (5.9 pmol/L). * Hemoglobin \<10.5 g/dL and/or neutrophils \<1500/mm3 and/or platelets \<100 000/mm3. * Positive test for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody (HCAb). * Positive urine pregnancy test in female of childbearing potential. * For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or end-stage renal disease. * Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying. * 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 immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes). * Mean fasting self-monitored plasma glucose (SMPG) is \>160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.