efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination versus insulin glargine in patients with type 2 diabetes (lixilan-india)

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (frc) to insulin glargine by demonstrating change in glycosylated hemoglobin (hba1c). secondary objectives: * to assess the effects of the frc in comparison with insulin glargine on: * percentage of patients reaching hba1c targets (\<7% ); * glycemic control in relation to a meal as evaluated by 2-hour post-prandial plasma glucose; (ppg); * body weight * fasting plasma glucose (fpg); * percentage of patients reaching hba1c targets of \<7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria); * 7-point self-monitoring plasma glucose (smpg) profile; * insulin glargine dose. * to assess the safety and tolerability in each treatment group.

the maximum study duration per patient is 33 weeks.

Eligibility criteria:
inclusion criteria : * patients with type 2 diabetes mellitus (t2dm) diagnosed for at least 1 year before the screening visit, * at screening: * age should be ≥ 18 years of age to \< 65 years; * glycosylated hemoglobin (hba1c) at screening visit ≥ 7.5% or ≤ 10%; * body mass index (bmi) ≥ 19 kg/m2 and ≤ 40 kg/m2. * patients who have been treated with a basal insulin for at least 6 months before the screening visit, and who have been on a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. the stable total daily dose should be within the range of 15-40 u, both inclusive, on the day of screening, but individual fluctuations of ± 20% within 2 months prior to screening are acceptable. exclusion criteria: * use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening. * previous use of insulin regimen other than basal insulin eg, prandial or pre-mixed insulin (note: short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator). * for patients taking metformin, any contraindication to metformin use, according to local labeling. * for patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m2 or end-stage renal disease. * personal or immediate family history of medullary thyroid cancer (mtc) or genetic condition that predisposes to mtc (eg, multiple endocrine neoplasia syndromes). * clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying. * history of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy. * average insulin glargine daily dose \ 50 u calculated for the last 3 days before visit 6. * amylase and/or lipase \>3 upper limit normal (uln) at visit 5 (week -1). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.