260-OR: iGlarLixi vs. Basal plus Rapid-Acting Insulin in Adults with Type 2 Diabetes Advancing from Basal Insulin Therapy: The SoliSimplify Real-World Study

Abstract

Introduction: Indirect evidence suggests iGlarLixi is as efficacious as basal insulin (BI) + rapid acting insulin (RAI) for management of type 2 diabetes (T2D) . However, there are no direct comparisons of iGlarLixi (once-daily [QD]) vs. a BI+RAI regimen (multiple daily injections [MDI]) . SoliSimplify compared these treatments using real-world data from a US database. Methods: Electronic medical records were analyzed retrospectively using propensity score matching (PSM) to compare therapy advancement with iGlarLixi or BI+RAI in adults ≥18 years with T2D on BI and ≥1 HbA1c available value at baseline and 6-month follow-up. The primary objective was non-inferiority of iGlarLixi to BI+RAI in HbA1c change from baseline to 6 months (margin 0.3 %) . Results: PSM generated cohorts with balanced baseline characteristics (N=814 in each group; Table) . HbA1c reduction from baseline to 6 months with iGlarLixi was non-inferior to BI+RAI (p<0.025) . Weight gain was significantly lower with iGlarLixi than with BI+RAI (p<0.for the difference) . At 6 months, achievement of HbA1c <7 % without hypoglycemia and weight gain was similar between groups. Hypoglycemia was low in both groups, likely due to underreporting. Conclusions: In this real-world study, QD iGlarLixi was as effective as MDI BI+RAI in HbA1c reduction and had a favorable body weight benefit. Disclosure R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. A.Y.Cheng: Advisory Panel; Abbott, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, HLS Theraoeutics, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Novo Nordisk, Sanofi, Board Member; Type 1 Diabetes Think Tank Network, Other Relationship; Diabetes Canada, Speaker's Bureau; Bausch Health, Canada, Merck & Co., Inc. G.R.Galstyan: n/a. K.Djaballah: Employee; Sanofi. X.Li: Employee; Eisai Co., Ltd., Sanofi. M.Coudert: Employee; Sanofi. J.Frias: Advisory Panel; Altimmune, Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi, Consultant; 89bio, Inc., Akero Therapeutics, Inc., Altimmune, Becton, Dickinson and Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk, Pfizer Inc., Sanofi, Research Support; Afimmune Limited, Akero Therapeutics, Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Speaker's Bureau; Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi. Funding Sanofi