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

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

The primary objective is to assess the effects of lixisenatide in comparison to placebo, when
added to insulin glargine and metformin, on glycemic control in terms of glycosylated
hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide on the percentage of
patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%,
plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self
monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability
(including anti-lixisenatide antibody assessment), and to assess the impact on treatment
satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the
participating countries where it is validated.