803-P: Superior Glycemic Control with Once-Weekly Insulin Icodec with a Dosing Guide App vs. Once-Daily (OD) Basal Insulin Analogs in Insulin-Naïve T2D—ONWARDS 5
Authors: BAJAJ HARPREET S. , ABERLE JENS , DAVIES MELANIE J. , DONATSKY ANDERS M. , FREDERIKSEN MARIE , GOGAS YAVUZ DILEK , GOWDA AMOOLYA , LINGVAY ILDIKO , BODE BRUCE W. 
Published: June 2023

ONWARDS 5 (NCT04760626), a 52-week, open-label, randomized, phase 3a trial with real-world elements, assessed effectiveness and safety of once-weekly insulin icodec with a dosing guide app (icodec) vs OD basal insulin analogs (degludec, glargine U100 or glargine U300) in insulin-naïve adults with T2D. Participants (mean: 59.3 yrs; 32.8 kg/m2) were randomized 1:1 to icodec or OD analogs. The dose guidance app aided icodec titration; OD analogs were titrated as per standard of care. Estimated mean A1C change from baseline (BL) to week 52 was greater with icodec (-1.68%-points, BL 9.0%) vs OD analogs (-1.31%-points, BL 8.9%) confirming non-inferiority (p&lt;0.0001) and superiority (p=0.009) of icodec vs OD analogs. Patient-reported outcomes (DTSQ and TRIM-D) were statistically significant in favor of icodec vs OD analogs at week 52. Rates of level 2 (&lt;54 mg/dL) or level 3 (severe) hypoglycemia were low for both treatments (0.19 [icodec] vs 0.14 [OD analogs] events per person-year of exposure). There were no significant differences between treatments in time to treatment discontinuation/intensification. Overall, icodec with a dosing guide app showed superiority in A1C reduction, and significant improvement in treatment satisfaction and compliance scores vs OD analogs, with low hypoglycemia rates, in insulin-naïve adults with T2D in a real-world setting.

Disclosure
H.S.Bajaj: Research Support; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Anji Pharmaceuticals, Eli Lilly and Company, Kowa Company, Ltd., Novo Nordisk, Pfizer Inc., Sanofi, Tricida, Inc. J.Aberle: Advisory Panel; Novo Nordisk, Speaker's Bureau; Novo Nordisk. M.J.Davies: Advisory Panel; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Lexicon Pharmaceuticals, Inc., Pfizer Inc., Medtronic, ShouTi Pharma Inc., Consultant; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Research Support; AstraZeneca, Novo Nordisk, Sanofi-Aventis U.S., Boehringer-Ingelheim, Janssen Pharmaceuticals, Inc., Speaker's Bureau; Lilly, Boehringer-Ingelheim, Novo Nordisk, AstraZeneca, Napp Pharmaceuticals Limited, Novartis, Sanofi. A.M.Donatsky: Employee; Novo Nordisk. M.Frederiksen: Employee; Novo Nordisk A/S. D.Gogas yavuz: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk, Boehringer-Ingelheim. A.Gowda: Employee; Novo Nordisk A/S. I.Lingvay: Advisory Panel; Novo Nordisk A/S, Lilly Diabetes, Boehringer-Ingelheim, Sanofi, Consultant; Carmot Therapeutics, Inc., Merck Sharp & Dohme Corp., Janssen Scientific Affairs, LLC, Pfizer Inc., Intercept, Intarcia, Valeritas, TargetRWE, Shionogi, Zealand Pharma, Structure, Bayer, Research Support; Novo Nordisk A/S, Boehringer-Ingelheim. B.W.Bode: Advisory Panel; Ascensia Diabetes Care, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Research Support; Abbott Diabetes, Abvance Therapeutics, Better Therapeutics, Inc, Dexcom, Inc., Diasome, Dompé, Insulet Corporation, Lilly Diabetes, Medtronic, Novo Nordisk, Sanvita Medical, Senseonics, Provention Bio, Inc., REMD Biotherapeutics, ViaCyte, Inc., Xeris Pharmaceuticals, Inc., vTv Therapeutics, Speaker's Bureau; Abbott Diabetes, American Diabetes Association, Boehringer Ingelheim and Eli Lilly Alliance, Insulet Corporation, Lilly Diabetes, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; Glytec, LLC.

Funding
Novo Nordisk A/S