Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

Inclusion criteria :

• Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before thescreening 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 thescreening visit, and who have been on a stable basal insulin regimen (ie, type ofinsulin and time/frequency of the injection), for at least 3 months before thescreening 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 2months prior to screening are acceptable.

Exclusion criteria:

• Use of oral or injectable glucose-lowering agents other than those stated in theinclusion criteria in the 3 months before screening.
• Previous use of insulin regimen other than basal insulin eg, prandial or pre-mixedinsulin (Note: Short term treatment due to intercurrent illness including gestationaldiabetes is allowed at the discretion of the investigator).
• For patients taking metformin, any contraindication to metformin use, according tolocal labeling.
• For patient not treated with metformin at screening: severe renal function impairmentwith an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stagerenal disease.
• Personal or immediate family history of medullary thyroid cancer (MTC) or geneticcondition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
• Clinically relevant history of gastrointestinal disease associated with prolongednausea and vomiting, including (but not limited to): gastroparesis, unstable (ie,worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophagealreflux disease requiring medical treatment, within 6 months prior to the time ofscreening visit; or history of surgery affecting gastric emptying.
• History of pancreatitis (unless pancreatitis was related to gallstones andcholecystectomy has been performed), pancreatitis during previous treatment withincretin therapies, chronic pancreatitis, pancreatectomy.
• Average insulin glargine daily dose <20 U or >50 U calculated for the last 3 daysbefore 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'spotential participation in a clinical trial.