Visual Abstract
Introduction: iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide, offers an alternative treatment advancement option to premix insulin for uncontrolled basal insulin-treated T2D. SoliMix, an open-label, multicenter study, was the first to compare these two insulin coformulations.
Methods: SoliMix randomized adults with T2D and HbA1c ≥7.5-≤10 % on basal insulin + oral antihyperglycemic drugs (OADs) to once-daily iGlarLixi or twice-daily premix insulin 70/30 analogue (BiAsp 70/30). 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.
Results: Both co-primary efficacy endpoints were met (Table), as well as iGlarLixi superiority vs. BiAsp 70/30 in HbA1c reduction. Significantly more participants reached HbA1c <7 % without weight gain, and HbA1c <7 % without weight gain and without hypoglycemia, in the iGlarLixi group than the BiAsp 70/30 arm. Incidence and rates of hypoglycemia (Level 1 or 2) were lower with iGlarLixi vs. BiAsp 70/30.
Conclusions: Based on better glucose control with weight benefit and less hypoglycemia, once-daily iGlarLixi is a favorable alternative to twice-daily premix 70/30 for advancing therapy in people with T2D uncontrolled on basal insulin + OADs.
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. N. Demil: Employee; Self; Sanofi. M. Bonnemaire: Employee; Self; Sanofi. R. J. Mccrimmon: Advisory Panel; Self; Novo Nordisk Inc., Sanofi-Aventis, Board Member; Self; Novo Nordisk Foundation, Research Support; Self; AstraZeneca. 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. C. Trescoli: None. S. N. Al sifri: None. N. Lalic: None. A. Alvarez: Employee; Self; Sanofi. P. Picard: None.
Sanofi (EudraCT 2017-003370-13)
