Dataset from A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in
comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period
of 12 weeks of treatment.

The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on
glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin
(HbA1c) reduction (absolute change) at Week 12.

Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on
glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration
regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour
postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and
tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.