Available IPD datapackage for study 'A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin'

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, over a period of 24 weeks of
treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide as an add-on treatment to
metformin in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effect of lixisenatide, in comparison to placebo,
when administered in the evening within 1 hour prior to the meal in terms of HbA1c reduction,
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), plasma glucose,
plasma insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test
(only in morning injection arms), body weight, beta-cell function assessed by homeostasis
model assessment (HOMA)-beta, fasting plasma insulin (FPI) and adiponectin; to evaluate
safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development,
beta-cell function 4 weeks after study drug discontinuation (only in patients from the
morning injection arms in some selected centers).