efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination versus insulin glargine in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: primary objective: to demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (frc) to insulin glargine in glycated hemoglobin (hba1c) change from baseline to week 30. secondary objective: to compare the overall efficacy and safety of insulin glargine/lixisenatide frc to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.

maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.

Eligibility criteria:
inclusion criteria : * type 2 diabetes mellitus diagnosed at least 1 year before the screening visit. * treatment with basal insulin for at least 6 months before the screening visit. * stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit. * stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 units/day for at least 2 months prior to the screening visit. * for participants receiving basal insulin and 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 could be 1 to 2 out of: * metformin (more than or equal to 1500 mg/day or maximal tolerated dose), * a sulfonylurea, * a glinide, * a dipeptidyl-peptidase-4 inhibitor, * a sodium glucose co-transporter 2 inhibitor, * fasting plasma glucose (fpg) less than or equal to 180 mg/dl(10.0 mmol/l) at screening visit for participants receiving basal insulin in combination with 2 oads or with 1 oad other than metformin; fpg less than or equal to 200 mg/dl (11.1 mmol/l) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit. * signed written informed consent. exclusion criteria: * age under legal age of adulthood at screening visit. * hba1c at screening visit less than 7.5% or above 10%. * pregnancy or lactation, women of childbearing potential with no effective contraceptive method. * use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening. * previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. note: short term treatment (≤10 days) due to intercurrent illness is allowed. * history discontinuation of a previous treatment with glucagon like peptide -1 receptor agonists for safety/tolerability or lack of efficacy. * participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide frc or had previously received lixisenatide. * 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 (eg, 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). * any contraindication to metformin use, according to local labeling, if the participant was taking metformin. * participant who had a renal function impairment with creatinine clearance less than 30 ml/min (using the cockcroft and gault formula) or end-stage renal disease for participants, not treated with metformin. exclusion criteria for randomization: * hba1c less than 7% or above 10% . * mean fasting smpg calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dl (7.8 mmol/l). * average insulin glargine daily dose less than 20 units or above 50 units (in the week before randomization visit). * 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.