748-P: Advancing Therapy in Uncontrolled Basal Insulin (BI)-Treated Type 2 Diabetes (T2D): Subanalysis of the SoliMix Trial in Participants in Europe

Abstract

Introduction: Premix insulin is commonly used as an option for therapy advancement from BI in T2D, despite a greater risk of hypoglycemia and weight gain compared with BI. Methods: SoliMix, an open-label, multicenter, randomized study, compared once-daily iGlarLixi to twice-daily premix insulin analog (BiAsp 70/30) in adults with T2D and HbA1c ≥7.5-≤10 % on BI + oral antihyperglycemic drugs (OADs). Co-primary efficacy endpoints were non-inferiority in HbA­1c reduction or superiority in bodyweight change from baseline to Week 26 of iGlarLixi vs. BiAsp 70/30. This predefined subanalysis assesses SoliMix endpoints in participants who were in Europe at the time of the study (43% of total study population). Results: Both co-primary efficacy endpoints were met, as well as iGlarLixi superiority vs. BiAsp 70/30 in HbA1c reduction (Table). Significantly more iGlarLixi-treated participants reached HbA1c Conclusions: Similar to the entire SoliMix cohort, once-daily iGlarLixi is a more favorable alternative to twice-daily premix insulin analog in people in Europe with T2D not at HbA1c target on BI + OADs, providing better glucose control, weight benefit, and less hypoglycemia. Disclosure A. Y. Cheng: Advisory Panel; Self; Abbott, AstraZeneca, Bayer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novo Nordisk, Sanofi, Research Support; Self; Applied Therapeutics, The Medicine Company, Speaker’s Bureau; Self; Abbott, AstraZeneca, Bausch Health, Canada, Bayer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Sanofi. M. Bonnemaire: Employee; Self; Sanofi. J. Rosenstock: Board Member; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Consultant; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Research Support; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Genentech, Inc., Intarcia Therapeutics, Inc., Lexicon Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Oramed Pharmaceuticals, Inc., Pfizer Inc., REMD Biotherapeutics, Sanofi. R. J. Mccrimmon: Advisory Panel; Self; Novo Nordisk Inc., Sanofi-Aventis, Board Member; Self; Novo Nordisk Foundation, Research Support; Self; AstraZeneca. V. Fonseca: Consultant; Self; Abbott Diabetes, Asahi Kasei Corporation, Bayer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Stock/Shareholder; Self; Amgen Inc., Bravo4health, Mellitus Health. C. Trescoli: None. M. Haluzik: Advisory Panel; Self; AstraZeneca, Lilly Diabetes, Novo Nordisk, Consultant; Self; Sanofi. J. Seufert: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk, Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Sanofi, Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk, Sanofi. A. Alvarez: Employee; Self; Sanofi. E. Souhami: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. P. Picard: None. Funding Sanofi (EudraCT 2017-003370-13)