Available IPD datapackage for study 'Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period'

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 metformin with or without sulfonylurea, over
a period of 24 weeks of treatment.

The primary objective is to assess the effects on glycemic control of lixisenatide (AVE0010)
in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in
terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide over 24 weeks on
percentage of patients reaching HbA1c less than (< ) 7 percent (%) or HbA1c less than or
equal to (<=) 6.5%, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG)
and glucose excursion during standardized meal test, body weight; to evaluate safety,
tolerability, pharmacokinetic (PK) and anti-lixisenatide antibody development.