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 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone

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 pioglitazone 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 pioglitazone on
glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at
Week 24.

Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on
the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to
6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic
model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to
assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody
development.