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

54 weeks +/-11 days

• lixisenatide AVE0010 (Drug): Pharmaceutical form:solution Route of administration: Subcutaneous injection
• biguanide (Drug): Pharmaceutical form:tablet Route of administration: oral
• TZD (Drug): Pharmaceutical form:tablet Route of administration: oral
• alpha-GI (Drug): Pharmaceutical form:tablet Route of administration: oral
• glinide (Drug): Pharmaceutical form:tablet Route of administration: oral

Primary outcomes

• Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data [52 weeks]

Secondary outcomes

• Absolute change in HbA1c [From baseline to weeks 24 and 52]
• Absolute change in fasting plasma glucose [From baseline to weeks 24 and 52]
• Absolute change in body weight [From baseline to weeks 24 and 52]

Sex: All, ages: 20 Years to any, accepts healthy volunteers

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.

• Clinical Sciences & Operations, Study director, Sanofi