Dataset from A Randomized, Double-Blind, Placebo-Controlled, 2-arm Parallel-group, Multicenter Study With a 24-Week Treatment Period Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Sulfonylurea

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 sulfonylurea,
over a period of 24 weeks of treatment.

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 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 daily basal insulin and total insulin doses; to evaluate
safety, tolerability, pharmacokinetics (PK), and anti-lixisenatide antibody development.