1-LB: Advancing Therapy in Basal Insulin Users with Type 2 Diabetes (T2D): Hypoglycemia as a Function of HbA1c in the SoliMix Trial

Abstract

Introduction: Therapeutic approaches to advancing treatment from basal insulin in T2D require assessment of the benefits and risks of any chosen intervention. Methods: SoliMix was a 26-week, open-label, multicenter study in which adults (N=887) with T2D and HbA1c ≥7.5-≤10.0 % (≥58-≤86 mmol/mol) using basal insulin + metformin ± sodium-glucose co-transporter-2 inhibitors were randomized to once-daily iGlarLixi (fixed-ratio combination of basal insulin glargine 100 U/mL + lixisenatide) or twice-daily premix insulin 30/70 analog (BiAsp 30). HbA1c improved and bodyweight changes were favorable with iGlarLixi vs. BiAsp 30 (primary outcomes), while hypoglycemia event rates were also lower with iGlarLixi vs. BiAsp 30. This subanalysis assessed estimated hypoglycemia event rates over the whole treatment period as a function of HbA1c at Week 26. Results: Modelled event profiles for clinically significant hypoglycemia (ADA Level 2 [ Conclusion: Lower rates of hypoglycemia with iGlarLixi across a broad range of HbA1c suggests that iGlarLixi facilitates greater HbA1c improvement vs. premix insulin 30/70. Disclosure 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. P. Home: Consultant; Self; American Diabetes Association, Kriya Technologies, Sanofi, Other Relationship; Self; Association of British Clinical Diabetologists, AstraZeneca, Novartis Malaysia, Sanofi, Research Support; Self; 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. F. Giorgino: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk, Roche Diabetes Care, Sanofi, Research Support; Self; Lilly Diabetes, Roche Diabetes Care. 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. E. Souhami: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. A. Alvarez: Employee; Self; Sanofi. A. H. Boss: Employee; Self; Sanofi, Stock/Shareholder; Self; Novo Nordisk A/S. L. Melas-melt: None. Funding Sanofi