Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Exclusion Criteria

• •Age \< legal age of adulthood (18 years).
• •Screening HbA1c \<7% or \>10%.
• •Screening FPG \>250 mg/dL (\>13.9 mmol/L).
• •Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
• •Type 1 diabetes mellitus.
• •Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening.
• •Use of insulin within the last 6 months.
• •Previous use of insulin, except for episode(s) of short-term treatment (≤15 consecutive days) due to intercurrent illness.
• •Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN) at screening.
• •Calcitonin ≥20 pg/ml (5.9 pmol/l) at screening.
• •Alanine Transferase (ALT) \>3 ULN at screening.
• •History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
• •Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes).
• •Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure \>180 mmHg or \>110 mmHg, respectively.
• •Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures.
• •Body Mass Index (BMI) ≤20 or \>40 kg/m\^2.
• •Any previous treatment with lixisenatide
• •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.