Dataset from A Randomized, Open-label, Active-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 Versus Exenatide on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin
收藏NIAID Data Ecosystem2026-05-10 收录
下载链接:
https://doi.org/10.25934/PR00007628
下载链接
链接失效反馈官方服务:
资源简介:
The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in
comparison to exenatide (Byetta®), 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 in comparison to exenatide
(Byetta®), as an add-on treatment to 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 (%) or HbA1c less than or equal to (<=) 6.5%, fasting
plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact
of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper
gastrointestinal disorders - quality of life [PAGI-QOL]).
创建时间:
2025-12-08



