efficacy and safety of lixilan versus insulin glargine alone both with metformin in japanese with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to compare lixilan to insulin glargine in glycated hemoglobin (hba1c) change from baseline to week 26 in patients with type 2 diabetes mellitus. secondary objective: to compare overall efficacy and safety of lixilan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.

the maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.

Eligibility criteria:
inclusion criteria : * patient with type 2 diabetes mellitus (t2dm) diagnosed for at least 1 year before the screening visit (v1). * patient treated with a stable, once a day basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. * the total daily basal insulin dose should be stable (± 20%) and \<15 u/day for at least 1 month before the screening visit. * patient receiving 1 or 2 oral anti-diabetic drugs (oads): the oad dose(s) must be stable during the 3 months before the screening visit. the oads can be 1 to 2 out of: * metformin; * sulfonylurea (su); * glinide; * dipeptidyl-peptidase-4 (dpp-4) inhibitor; * sodium glucose co-transporter 2 (sglt2) inhibitor; * alpha glucosidase inhibitor (alpha-gi). * signed written informed consent. exclusion criteria: * age \<20 years at screening visit. * hba1c at screening visit \ 9.5%. * fasting plasma glucose (fpg) \>180 mg/dl (10.0 mmol/l) at screening visit. * 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 in the 3 months before screening visit. * previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin. note: short-term treatment (≤10 days) due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator. * use of thiazolidinedione (tzd) within 6 months prior to screening visit. * history of discontinuation of a previous treatment with a glucagon-like peptide-1(glp-1) receptor agonist due to safety/ tolerability issues or lack of efficacy. * laboratory findings at the screening visit; including: * amylase and/or lipase \>3 times the upper limit of the normal (uln) laboratory range; * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>3 uln; * calcitonin ≥20 pg/ml (5.9 pmol/l); * positive serum pregnancy test. * any contraindication to metformin use according to local labeling. * history of hypersensitivity to any glp-1 receptor agonist or to metacresol. * contraindication to use of insulin glargine or lixisenatide according to local labeling. history of hypersensitivity to insulin glargine or to any of the excipients. * 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 now been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. * exclusion criteria for randomization at the end of the run-in phase: * hba1c \ 9.5% at visit 6 (week -1). * mean fasting self monitored plasma glucose (smpg) \>160 mg/dl (8.9 mmol/l), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization. note:fasting smpg on the day of randomization can be included if assessed before randomization. * average insulin glargine daily dose ≥15 u/day or \<5u/day calculated for the last 3 days before visit 7. * metformin total daily dose \<750 mg/day. * amylase and/or lipase \>3 uln at visit 6 (week -1). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.