A Randomized, Open Label, Parallel-group (One-step Titration and Two-step Titration), Multicenter 52-Week Study Followed by a 24-Week Extension Assessing the Safety and Tolerability of AVE0010 Monotherapy in Patients With Type 2 Diabetes

The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) used
as 2-step initiation regimen and 1-step initiation regimen in Japan, over a period of 24
weeks of treatment, followed by an extension up to Week 76.

The primary objective of this study is to evaluate the safety of lixisenatide once daily
treatment in monotherapy at Week 24 by a descriptive comparison of a 1-step initiation and a
2-step initiation regimen in patients with type 2 diabetes in Japan.

The secondary objectives are to assess the overall safety of lixisenatide once daily
treatment in monotherapy at Week 52 and Week 76; to assess the effects of lixisenatide on
glycosylated hemoglobin (HbA1c) reduction at Week 52 and Week 76, body weight, and fasting
plasma glucose (FPG); to assess pharmacokinetics (PK) and anti-lixisenatide antibody
development.