At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Lixisenatide (AVE0010), Pen auto-injector, and 3 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 639 participants across 18 sites in 18 countries.
Detailed Summary
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 \[PAGI-QOL\]).
Study Details
Timeline
Interventions
Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Self administered by subcutaneous injections twice daily within the hour preceding breakfast and within the hour preceding dinner.
Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.