Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

Approximately 41 weeks including a 26 week treatment period

Inclusion criteria :

- Patients with type 2 diabetes mellitus diagnosed at least 1 year before screening
visit (V1) .

- Patients treated with basal insulin for at least 6 months.

- Patients treated for at least 3 months prior to visit 1 with a stable basal insulin
regimen (ie type of insulin and time/frequency of the injection). The insulin dose
should be stable (± 20 %) and ≥20 U/day for at least 2 months prior to visit 1.

- Patients treated with basal insulin alone or in combination with 1 to 3 oral
anti-diabetic drugs (OADs) that can be: metformin (≥1.5g/day or maximal tolerated
dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide.
The dose of OADs should be stable for at least 3 months prior to visit 1.

Exclusion criteria:

- At screening: age < legal age of majority

- At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone
or in combination with metformin only; < 7.0% and > 10.0% for patients treated with
basal insulin and a combination of oral anti-diabetic drugs which includes a SU
and/or a DPP-4 inhibitor and/or a glinide.

- Women of childbearing potential with no effective contraceptive method, pregnancy or
lactation

- Type 1 diabetes mellitus

- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria
within 3 months prior to screening.

- Previous treatment with short or rapid acting insulin other than in relation to
hospitalization or an acute illness.

- Any previous treatment with lixisenatide, or any discontinuation from another GLP-1
receptor agonist due to safety/tolerability issue or lack of efficacy.

- At screening, Body Mass Index (BMI) ≤20 or >40 kg/m².

- Weight change of more than 5 kg during the 3 months prior to the screening visit; use
of weight loss drugs within 3 months prior to screening.

- Within the last 6 months prior to screening: history of myocardial infarction,
stroke, or heart failure requiring hospitalization. Planned coronary, carotid or
peripheral artery revascularisation procedures.

- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,
stomach/gastric surgery.

- At screening resting systolic blood pressure > 180 mmHg or diastolic blood pressure >
95 mmHg

- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic
condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)

- Contraindication related to metformin (for patient receiving this treatment), insulin
glargine, insulin glulisine or lixisenatide.

- Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or
end-stage renal disease.

- At screening, amylase and/or lipase > 3 times the upper limit of the normal
laboratory range (ULN)

- At screening ALT or AST>3ULN

- At screening calcitonin ≥20 pg/ml (5.9 pmol/L)

Exclusion Criteria for randomization at the end of the screening period before
randomization:

- HbA1c <7.0% or >9.0%.

- 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).

- Amylase and/or lipase > 3 times ULN.

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