Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

54 weeks +/-11 days

Inclusion criteria

• Patients with type 2 diabetes mellitus diagnosed at least 1 year before the screening visit
• Patient treated for at least 3 months prior to screening visit with one of following OADs at a stable dose of at least usual maintenance dose as described in the label

• a biguanide (metformin hydrochloride);
• a thiazolidinedione (TZD) (pioglitazone hydrochloride);
• an alpha-glucosidase inhibitor (alpha-GI) (acarbose, voglibose or miglitol);
• or a glinide (nateglinide, repaglinide or mitiglinide);
• Signed written informed consent

Exclusion criteria

• At screening HbA1c <7% or >9.5%;
• At screening: fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
• Use of any glucose-lowering agent(s) other than the authorized patient's background treatment defined in I02 (as given in inclusion critieria) within 3 months prior to screening;
• Type 1 diabetes mellitus;
• Women of childbearing potential with no effective contraceptive method;
• Pregnancy or lactation;
• Laboratory findings at the time of screening:

• Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN);
• ALT >3 ULN;
• Any contra-indication to the patient's background oral anti-diabetic treatment;
• 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);
• Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP1 receptor agonist.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.