Visual Abstract
Introduction: In many regions outside Europe, premix insulin is commonly used to advance therapy from BI when HbA1c targets are not met in T2D, despite a greater risk of hypoglycemia and weight gain than 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 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 outside Europe at the time of the study (57% of the total study population).
Results: Both co-primary endpoints were met, as well as iGlarLixi superiority vs. BiAsp 70/30 in HbA1c reduction (Table). Significantly more iGlarLixi-treated participants reached HbA1c <7 % without weight gain, and HbA1c <7 % without weight gain and without hypoglycemia. Incidence of hypoglycemia (Level 1 or 2) was lower with iGlarLixi vs. BiAsp 70/30.
Conclusions: Similar to the entire cohort of SoliMix, once-daily iGlarLixi is a more favorable option to twice-daily premix insulin analog in people outside Europe with T2D not at HbA1c target on BI + OADs, providing better glucose control with weight benefit and less hypoglycemia.
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. P. Picard: None. E. Souhami: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. R. J. Mccrimmon: Advisory Panel; Self; Novo Nordisk Inc., Sanofi-Aventis, Board Member; Self; Novo Nordisk Foundation, Research Support; Self; AstraZeneca. 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. 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. R. Emral: Advisory Panel; Self; Lilly Diabetes, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk, Sanofi. L. Sauque-reyna: None. V. Mohan: None. S. N. Al sifri: None. A. Alvarez: Employee; Self; Sanofi. K. Djaballah: Employee; Self; Sanofi.
Sanofi (EudraCT 2017-003370-13)
