Introduction & objective: This post hoc analysis assessed the efficacy and safety of once-weekly insulin icodec (icodec) vs once-daily (OD) basal insulin in insulin-naive (ONWARDS 1, 3, 5) and insulin-experienced (ONWARDS 2, 4) adults with T2D by kidney function subgroup.
Methods: Treatment outcomes were analyzed by kidney function subgroup (eGFR ≥90; eGFR ≥60-<90; eGFR ≥30-<60; eGFR <30; all mL/min/1.73m2).
Results: In ONWARDS 1, 3, and 5, there were no statistically significant treatment by kidney function subgroup interactions for change in A1C from baseline to planned end of treatment (EOT); however, in ONWARDS 2 and 4, there were significant subgroup interactions (Figure). No trend for heterogeneity was observed by kidney function subgroup for overall rates of clinically significant or severe hypoglycemia. Across kidney function subgroups, the proportion of participants achieving A1C <7% without clinically significant or severe hypoglycemic episodes at EOT was similar or higher for icodec vs comparators. Additionally, there were no statistically significant differences in average weekly insulin doses for icodec vs OD comparators by kidney function subgroup during the last 2 weeks of treatment in ONWARDS 1-5.
Conclusion: Overall, the efficacy and safety for once-weekly icodec vs OD comparators was consistent, with no trend across kidney function subgroups.
P. Rossing: Other Relationship; AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Gilead Sciences, Inc., Novo Nordisk, Eli Lilly and Company, Novartis AG, Abbott Diagnostics. M. Benamar: Employee; Novo Nordisk A/S. A.Y.Y. Cheng: Advisory Panel; Abbott. Speaker's Bureau; Amgen Inc., AstraZeneca, Bausch Health. Advisory Panel; Bayer Inc. Speaker's Bureau; Abbott, Bayer Inc. Research Support; Applied Therapeutics Inc. Advisory Panel; Boehringer-Ingelheim. Speaker's Bureau; Boehringer-Ingelheim, Dexcom, Inc. Advisory Panel; Dexcom, Inc., Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Advisory Panel; Eisai Inc. Speaker's Bureau; GlaxoSmithKline plc. Advisory Panel; HLS Therapeutics Inc. Speaker's Bureau; HLS Therapeutics Inc., Insulet Corporation. Advisory Panel; Insulet Corporation, Janssen Pharmaceuticals, Inc. Speaker's Bureau; Janssen Pharmaceuticals, Inc., Medtronic. Advisory Panel; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Novo Nordisk. Speaker's Bureau; Pfizer Inc. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi. Research Support; Sanofi. Advisory Panel; Takeda Canada, AstraZeneca, Sanofi. Consultant; Abbott, AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Dexcom, Inc., Eisai Inc., Eli Lilly and Company, Insulet Corporation, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi, Takeda Pharmaceutical Company Limited. C. Laugesen: Employee; Novo Nordisk. Stock/Shareholder; Novo Nordisk. P. Nielsen: Employee; Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. H.S. Bajaj: Research Support; Abbott, Amgen Inc., Anji Pharmaceuticals, Boehringer-Ingelheim, Eli Lilly and Company, Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc.
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