efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination (lixilan) to insulin glargine alone on top of oral anti-diabetic drugs (oads) with type 2 diabetes in japan

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. secondary objective: to compare the overall efficacy and safety of lixilan to insulin glargine (with or without oads) over a 26 week treatment period in patients with type 2 diabetes.

the maximum study duration per patient will be approximately 29 weeks: an up to 2-week screening period, a 26-week randomized open-label 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, receiving 1 or 2 oads that can be biguanide,thiazolidinedione (tzd), -alpha-glucosidase-inhibitor (alpha-gi),sodium glucose co-transporter 2 (sglt2) inhibitor,sulfonylurea (su),rapid-acting insulin secretagogue (glinide),diphenyl-peptidase -4 inhibitor (dpp-4 inhibitor). * signed written informed consent. exclusion criteria: * at the screening visit: age \<20 years. * at the screening visit: hba1c \ 9.5%. * at the screening visit: fasting plasma glucose (fpg) \>180 mg/dl (10.0 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 during the inclusion criteria in 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 time of screening: * 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 in female of childbearing potential. * contraindication to use of lixisenatide according to the local labeling. history of hypersensitivity to any glucagon-like peptide-1 receptor agonists or to metacresol. * contraindication to use of insulin glargine according to 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/1.73 m\^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.