811-P: Safety and Effectiveness of iGlarLixi in People with Type 2 Diabetes Mellitus (T2DM) in South Korea

Introduction & Objective: The fixed ratio combination of insulin glargine and lixisenatide, iGlarLixi, was indicated as antihyperglycemic for people with T2DM and approved in November 2017 in South Korea. This post marketing surveillance (PMS) study aimed to evaluate the safety and effectiveness of iGlarLixi in clinical practice setting. Methods: This study was a multicenter, prospective, single-arm, observational study conducted in Korean people with T2DM from August 2018 to August 2023. Primary endpoint was to investigate safety profile. Secondary endpoints included changes in HbA1c, FPG and 2-hour PPG from baseline to Week 12 and 24. Results: Out of 743 people enrolled, 625 were included in safety evaluation and 519 in effectiveness evaluation. The mean age was 60.9 years and duration of T2DM was 13.6 years with equal proportions of male and female participants. Adverse events (AEs) and adverse drug reactions (ADRs) were reported in 120 (19.2%, 163 events) and 51 (8.2%, 63 events) participants, respectively. Most common AEs were gastrointestinal disorders (6.7%) such as nausea, decreased appetite, and vomiting. Significant reductions in HbA1c, FPG, 2-hour PPG were observed from baseline to Weeks 12 and 24 (Table). Conclusion: In clinical practice, iGlarLixi has shown to be safe and well tolerated without new safety concerns improving clinical outcomes in people with T2DM in South Korea.