A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

Primary Objective:

- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an
add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over
a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

- To assess the effects of lixisenatide over 24 weeks on :

- percentage of patients reaching HbA1c<7% or ≤6.5%,

- 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during
standardized meal challenge test,

- fasting plasma glucose (FPG),

- change in 7-point self-monitored plasma glucose (SMPG) profile),

- body weight,

- change in daily basal insulin dose.

- To assess lixisenatide safety and tolerability.

- To assess anti-lixisenatide antibody development.