A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 on Top of a Sulfonylurea in Patients With Type 2 Diabetes Not Adequately Controlled With 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 sulfonylurea without or with metformin, over
a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to sulfonylurea
with or without 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 percentage of patients
reaching HbA1c less than (<) 7 percent (%); percentage of patients reaching HbA1c less than
or equal to (<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed
by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG),
glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a
sub-study in all patients in selected centers; to evaluate safety, tolerability,
pharmacokinetics (PK) and anti-lixisenatide antibody development.

本研究旨在评估利西拉肽（lixisenatide，AVE0010）对比安慰剂，作为伴或不伴二甲双胍的磺脲类药物的附加治疗方案的获益与风险，治疗周期为24周，后续设有延长期。

主要研究目的为评估：在第24周时，利西拉肽联合伴或不伴二甲双胍的磺脲类治疗，对糖化血红蛋白（HbA1c）降幅（绝对变化值）这一血糖控制指标的影响。

次要研究目的包括：评估利西拉肽对以下指标的影响：达到HbA1c＜7%的患者占比、达到HbA1c≤6.5%的患者占比；患者体重；空腹血浆葡萄糖（FPG）；通过稳态模型评估（HOMA）评估的β细胞功能；在入选中心的全部患者中开展的亚研究内，标准化餐食刺激试验后的2小时餐后血浆葡萄糖（PPG）、胰高血糖素、胰岛素、胰岛素原及C肽水平；同时评估安全性、耐受性、药代动力学（PK）以及抗利西拉肽抗体的产生情况。