efficacy and safety of insulin glargine/ lixisenatide fixed ratio combination compared to insulin glargine alone and lixisenatide alone on top of metformin in patients with t2dm

Conditions: Type 2 Diabetes

Summary: primary objective: to compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (hba1c) change from baseline to week 30. secondary objective: to compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (frc) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.

approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days follow-up period.

Eligibility criteria:
inclusion criteria: * participants with type 2 diabetes mellitus diagnosed for at least 1 year before the screening visit, treated for at least 3 months prior to visit 1 with metformin alone or metformin and a second oral anti-diabetic treatment that could be a sulfonylurea, a glinide, a sodium glucose co-transporter-2 inhibitor or a di-peptidyl peptidase 4 (dpp-4) inhibitors, and who were not adequately controlled with this treatment. * signed written informed consent. exclusion criteria: * hba1c at screening visit: * less than 7.5% or more than 10% for participants previously treated with metformin alone, * less than 7.0% or more than 9% for participants previously treated with metformin and a second oral anti-diabetic treatment. * pregnancy or lactation, women of childbearing potential with no effective contraceptive method. * use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening. * previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician). * history of discontinuation of a previous treatment with a glucagon-like peptide (glp-1) receptor agonist (glp-1 ra) due to safety/tolerability issue or lack of efficacy. * participant who previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or had previously received lixisenatide. * any contraindication to metformin use, according to local labeling. * use of weight loss drugs within 3 months prior to screening visit. * within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period. * history of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. * personal or immediate family history of medullary thyroid cancer (mtc) or genetic conditions that predispose to mtc (e.g, multiple endocrine neoplasia syndromes). * uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmhg or diastolic blood pressure above 95 mmhg) at screening visit. * at screening visit, body mass index (bmi) less than or equal to 20 or above 40 kg/m\^2. * at screening visit amylase and/or lipase more than 3 times the upper limit of the normal (uln) laboratory range. * at screening visit alanine aminotransferase (alt) or alkaline phosphatase (ast) more than 3 uln. * at screening visit calcitonin above or equal to 20 pg/ml (5.9 pmol/l). exclusion criteria for randomization at the end of the screening period: * hba1c less than 7% or above 10%; * fasting plasma glucose above 250 mg/dl (13.9 mmol/l); * metformin maximal tolerated dose less than 1500 mg/day; * amylase and/or lipase more than 3 uln. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.