Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

Inclusion criteria :

• Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before thescreening visit, receiving 1 or 2 OADs that can be biguanide, thiazolidinedione,alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea,rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor.

• Signed written informed consent.

Exclusion criteria:

• At the screening visit: age <20 years.

• At the screening visit: HbA1c <7.5% or >10%.

• At the screening visit: fasting plasma glucose (FPG) >250 mg/dL (13.8 mmol/L).

• Pregnancy or lactation, women of childbearing potential with no effectivecontraceptive method.

• Use of oral or injectable glucose-lowering agents other than those stated in theinclusion criteria during the 3 months before the screening visit.

• Previous treatment with insulin (except for short-term treatment due to intercurrentillness including gestational diabetes at the discretion of the trial physician).

• Laboratory findings at the screening visit, including:

• Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN),

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN,

• Calcitonin ≥20 pg/mL (5.9 pmol/L),

• Positive serum pregnancy test.

• Contraindication to use of lixisenatide according to the local labeling. History ofhypersensitivity to any glucagon-like peptide-1 receptor agonist (GLP-1RA) or tometacresol.

• Contraindication to use of insulin glargine according to the local labeling. Historyof hypersensitivity to insulin glargine or to any of the excipients.

• Patient who has a severe renal function impairment with estimated glomerularfiltration rate (eGFR) <30 mL/min/1.73m^2 or end-stage renal disease for patient nottreated with metformin.

• Personal or immediate family history of medullary thyroid cancer (MTC) or geneticcondition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).

• History of pancreatitis (unless pancreatitis was related to gallstones andcholecystectomy has been performed), pancreatitis during previous treatment withincretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.