A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in
comparison to placebo, as an add-on treatment to basal insulin with or without metformin over
a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to basal insulin on
glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.

The secondary objectives are to assess the effects of lixisenatide when added to basal
insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal
challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of
patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in
7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total
insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide
antibody development.