A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen

Primary objective:

- To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic
control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes
participants (T2DM) who are inadequately controlled with their current anti-diabetic
treatment regimen.

Main secondary objective:

- To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM
participants (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic
hypoglycemia and gastrointestinal side effects).

Other secondary objectives:

- To assess the effect of lixisenatide compared to placebo after 24-week treatment on:

- Fasting plasma glucose (FPG);

- During liquid standardized breakfast meal challenge test : 2 hour- Postprandial
Plasma Glucose (PPG) and Plasma Glucose Excursion;

- 7-point Self-monitored plasma glucose (SMPG) profile;

- Body weight;

- Change in total daily dose of basal insulin (if taken);

- Percentage of participants requiring rescue therapy

- Safety and tolerability;

- To assess lixisenatide pharmacokinetic profile;

- To assess anti-lixisenatide antibody development.