Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

Approximately 31 weeks including 24 week treatment period

Inclusion criteria :

- Older patients, aged 70 years and above, with T2DM inadequately controlled on their
current anti-diabetic pharmaceutical treatment regimen

- Signed written informed consent

Exclusion criteria:

- At screening HbA1c ≤7.0% or >10% (Acknowledging that the threshold of 7% may not be
appropriate for all older patients and that this is the responsibility of the
investigator to include the patient based on an individual evaluation of the expected
benefits of better glycemic control versus risk of hypoglycemia)

- At screening patients on both basal insulin and sulfonylurea or basal insulin and
meglitinides

- At screening FPG >250 mg/dL (>13.9 mmol/L)

- Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the
screening visit.

- Type 2 diabetes mellitus diagnosed less than 1 year prior to screening

- Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months
prior to screening

- Treatment within the 3 months preceding the screening with other antidiabetic agent
than allowed background therapy. Allowed therapy includes metformin, sulfonylurea
[except glibenclamide >10mg, glicazide >160mg], meglitinides [except repaglinide
>6mg], pioglitazone and basal insulin and should follow local product circulars and
labeling restrictions for the study population. .

- Patients who have been on an approved or an investigational GLP-1 medication
(exenatide, liraglutide, lixisenatide or others)

- History of severe hypoglycemia associated with symptoms unawareness or results in
unconsciousness/coma/seizure in the 6 months prior to screening

- BMI <22 or >40 kg/m²

- Malnutrition assessed clinically by the investigator or any sub-investigator and by
MNA-SF score <12 in countries (the judgment of the investigator prevails on
questionnaires scores)

- Cognitive disorder and dementia assessed clinically by the investigator or any sub
investigator and by MMSE score <24 (the judgment of the investigator prevails on
questionnaires scores), or any neurologic disorder that will affect the patient's
ability to participate in the study

- Patient who have an eGFR (using the Modification of Diet in Renal Disease {MDRD}
formula <30ml/min/1.73m2

- Patients with severe or uncontrolled disease, or any clinically significant
abnormality identified on physical examination or investigational clinical procedure
that, in the judgment of the investigator or any sub-investigator, would preclude
safe completion of the study or constrains efficacy assessment

- Laboratory findings at the time of screening:

- Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory
range

- ALT or AST >3 times ULN

- Calcitonin >20 pg/mL (5.9 pmol/L)

- Clinically relevant history of gastrointestinal disease associated with prolonged
nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie,
worsening) and not controlled (ie, prolonged nausea and vomiting) gastroesophageal
reflux disease within 6 months prior to screening

- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,
stomach/gastric surgery, inflammatory bowel disease

- Personal or immediate family history of medullary thyroid cancer or genetic
conditions that predisposes to medullary thyroid cancer (eg, multiple endocrine
neoplasia syndromes)

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