746-P: Advancing Therapy in Uncontrolled Basal Insulin-Treated Type 2 Diabetes (T2D): Nocturnal Hypoglycemia in the SoliMix Trial

Abstract

Introduction: Advancing treatment from basal insulin (BI) to premix insulin may improve glycemic control, though at the expense of greater hypoglycemia risk, including nocturnal hypoglycemia.Methods: SoliMix was a 26-week open-label, multicenter, randomized trial comparing iGlarLixi vs. premix insulin analog (BiAsp 70/30) in adults with T2D and HbA1c ≥7.5-≤10 % on BI + oral antihyperglycemic drugs (OADs). Primary results showed that switching to once-daily iGlarLixi resulted in better glucose control vs. twice-daily BiAsp 70/30. This subanalysis assessed nocturnal hypoglycemia (defined as bedtime-waking or 00:00-06:00 h [any; any symptomatic; ADA Level 1, 2, 3]) during the 26-week study period.Results: Incidence and rates of ADA Level 2 and any symptomatic nocturnal hypoglycemia were lower with iGlarLixi vs. BiAsp 70/30 for both nocturnal time intervals (Table). Incidence and rates of any and Level 1 nocturnal hypoglycemia were lower with iGlarLixi vs. BiAsp 70/30 between 00:00 and 06:00. No nocturnal ADA Level 3 (severe) hypoglycemia occurred in either treatment arm.Conclusions: Switching to iGlarLixi resulted in better glucose control with less nocturnal (00:00-06:00) hypoglycemia vs. premix insulin analog. A reduction in ADA Level 2 and any symptomatic hypoglycemia was also observed for the more clinically relevant window of bedtime to waking.View largeDownload slideView largeDownload slide DisclosureR. 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. 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. R. Choza: None. T. Alessa: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi-Aventis, Research Support; Self; Servier Laboratories, Speaker’s Bureau; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi-Aventis, Servier Laboratories. A. Alvarez: Employee; Self; Sanofi. E. Souhami: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. A. H. Boss: Employee; Self; Sanofi, Stock/Shareholder; Self; Novo Nordisk A/S. P. Picard: None.FundingSanofi (EudraCT 2017-003370-13)