efficacy and safety of lixisenatide versus insulin glulisine on top of insulin glargine with or without metformin in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: primary objective: - to compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (hba1c) reduction and body weight change at week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. secondary objectives: - to compare the treatments/regimens on: * the percentage of participants reaching the target of hba1c \<7% or ≤6.5%, * body weight, * self-monitored glucose profiles, * fasting plasma glucose (fpg), * post-prandial plasma glucose (ppg) /glucose excursions during a standardized meal test (subset of participants), * daily doses of insulins, * safety and tolerability.

approximately 41 weeks including a 26 week treatment period.

Eligibility criteria:
inclusion criteria : * participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (v1). * participants treated with basal insulin for at least 6 months. * participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). the insulin dose should be stable (± 20%) and ≥20 u/day for at least 2 months prior to visit 1. * participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (oads) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (su), a dipeptidyl-peptidase-4 (dpp-4) inhibitor, a glinide. the dose of oads should be stable for at least 3 months prior to visit 1. exclusion criteria: * at screening: age \< legal age of majority. * at screening, hba1c: \ 10.0% for participants treated with basal insulin alone or in combination with metformin only; \ 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a su and/or a dpp-4 inhibitor and/or a glinide. * women of childbearing potential with no effective contraceptive method, pregnancy or lactation. * type 1 diabetes mellitus. * treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening. * previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness. * any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (glp-1) receptor agonist due to safety/tolerability issue or lack of efficacy. * at screening, body mass index (bmi) ≤20 or \>40 kg/m\^2. * weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening. * within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. planned coronary, carotid or peripheral artery revascularisation procedures. * history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. * at screening resting systolic blood pressure \>180 mmhg or diastolic blood pressure \>95 mmhg. * personal or immediate family history of medullary thyroid cancer (mtc) or genetic condition that predisposed to mtc (e.g. multiple endocrine neoplasia syndromes). * contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide. * participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. * at screening, amylase and/or lipase \>3 times the upper limit of the normal laboratory range (uln). * at screening alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>3 uln. * at screening calcitonin ≥20 pg/ml (5.9 pmol/l). exclusion criteria for randomization at the end of the screening period before randomization: * hba1c \ 9.0%. * 7-day mean fasting smpg \>140 mg/dl (7.8 mmol/l). * amylase and/or lipase \>3 times uln. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.