1146-P: Switching to iGlarLixi vs. Continued Treatment of GLP-1RA: Comparative Analysis by Daily or Weekly GLP-1RAs in the LixiLan-G Trial

Abstract

LixiLan-G (NCT02787551) was a randomized, open-label, 26-week trial in T2D participants (pts) with HbA 1c 7‒9%, receiving maximum tolerated doses of a once- or twice-daily (QD/BID) GLP-1 RA or a once-weekly (QW) GLP-1 RA with metformin ± pioglitazone ± SGLT2i. Pts were randomized to continue their GLP-1 RA regimen with supported adherence or switch to a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi). This exploratory analysis assessed efficacy and safety by daily or weekly GLP-1 RA use at screening. Among 514 randomized pts, 60% and 40% were on daily and weekly GLP-1 RA, respectively, at screening (liraglutide QD 54%, dulaglutide QW 20%, exenatide extended-release QW 18%, exenatide BID 5%, albiglutide QW 2% [all % rounded]); GLP-1 RA treatment and T2D duration were slightly longer in the QD/BID vs. QW subgroup (Table). Change in HbA 1c was larger with iGlarLixi vs. GLP-1 RA regardless of GLP-1 RA subtype (LS mean difference: −0.7 [95% confidence interval (CI): −0.8, −0.5] with QD/BID formulations, −0.6 [95% CI: −0.8, −0.4] with QW formulations). Similar results were observed for FPG and 2-hour PPG (Table). Safety profiles of iGlarLixi and GLP-1 RA were consistent with previous publications. In conclusion, benefits of switching to iGlarLixi vs. continued GLP-1 RA in inadequately controlled T2D are observed irrespective of daily or weekly GLP-1 RA use. Disclosure J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. L. Blonde: Consultant; Self; Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Research Support; Self; Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. Speaker9s Bureau; Self; Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US. S. Del Prato: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi, Servier, Takeda Pharmaceutical Company Limited. Board Member; Self; AstraZeneca. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker9s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited. R.R. Henry: Advisory Panel; Self; Elcelyx Therapeutics, Inc. Consultant; Self; Diasome Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc. Employee; Self; Eli Lilly and Company. Research Support; Self; AstaReal, Hitachi, Ltd., Viacyte, Inc. Speaker9s Bureau; Self; Servier. Other Relationship; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Johnson & Johnson, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi-Aventis. N. Shehadeh: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi-Aventis. Speaker9s Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp. E. Niemoeller: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. E. Souhami: Employee; Self; Sanofi Research & Development. J. Wu: Employee; Self; Sanofi. X. Wang: Employee; Self; Sanofi Research & Development. C. Ji: Employee; Self; Sanofi Research & Development. V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research & Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. Funding Sanofi