At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes diagnosed at least 1 year prior to screening
- ✓Currently on GLP-1 receptor agonist (liraglutide, exenatide, exenatide extended-release, albiglutide, or dulaglutide) at stable dose for ≥3-6 months
- ✓Concurrent metformin at dose ≥1500 mg/day or maximum tolerated dose
- ✓HbA1c 7–9% at screening
- ✕Age <18 years
- ✕Any insulin use in the year prior to screening (short-term ≤10 days for intercurrent illness allowed)
- ✕Any antidiabetic drugs within 3 months prior to screening other than those specified in inclusion
- ✕Estimated glomerular filtration rate <30 mL/min/1.73m² or end-stage renal disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period
In Brief
A Phase 3 clinical trial evaluating Insulin glargine/lixisenatide fixed ratio combination, liraglutide, and 5 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 514 participants across 124 sites in 9 countries.
Detailed Summary
Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 \[SGLT2\] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.
Study Details
Timeline
Interventions
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.