Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

Exclusion Criteria

• •At screening
• •age \<20 years;
• •HbA1c \<7% or \>9.5% (for patients on OAD \<6.5% or \>8.5%);
• •fasting plasma glucose \>250 mg/dL (\>13.9 mmol/L);
• •Use of more than one OAD within 3 months prior to screening;
• •Use of Thiazolidinedione (TZD) within 6 months prior to screening;
• •Use of insulin within 3 months prior to screening; Note: Short time use (≤10 days) of insulin due to acute illness or surgery (eg, infectious disease) is allowed.
• •Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP-1 receptor agonist;
• •Type 1 diabetes mellitus
• •Women of childbearing potential with no effective contraceptive method;
• •Pregnancy or lactation;
• •Laboratory findings at the time of screening:
• •oAmylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN);
• •ALT \>3 ULN;
• •Calcitonin ≥20 pg/mL (5.9 pmol/L);
• •Positive serum pregnancy test in women of childbearing potential;
• •History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease;
• •Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes);
• •Allergic reaction to metacresol.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.