At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled on Basal Insulin With or Without Oral Antidiabetic Drug(s)
In Brief
A Phase 3 clinical trial evaluating Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 426 participants across 45 sites.
Detailed Summary
Primary Objective: To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin. Secondary Objectives: * To assess the effects of iGlarLixi in comparison with insulin glargine * To assess the safety in each treatment group
Study Details
Timeline
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: tablet Route of administration: oral