Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial.

BACKGROUND

ONWARDS 6 compared the efficacy and safety of once-weekly subcutaneous insulin icodec (icodec) and once-daily insulin degludec (degludec) in adults with type 1 diabetes.

METHODS

This 52-week (26-week main phase plus a 26-week safety extension), randomised, open-label, treat-to-target, phase 3a trial was done at 99 sites across 12 countries. Adults with type 1 diabetes (glycated haemoglobin [HbA

FINDINGS

Between April 30 and Oct 15, 2021, of 655 participants screened, 582 participants were randomly assigned to icodec (n=290) or degludec (n=292). At week 26, from baseline values of 7·59% (icodec) and 7·63% (degludec), estimated mean changes in HbA

INTERPRETATION

In adults with type 1 diabetes, once-weekly icodec showed non-inferiority to once-daily degludec in HbA

FUNDING

Novo Nordisk.

Informations de copyright

Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests DR-J reports research income or advisory board honoraria from AstraZeneca, Dexcom, Lilly, Medtronic, Novartis, Novo Nordisk, and Sanofi. TB has received research grants from Abbott, Daiichi Sancho, Eli Lilly, Ono Pharmaceuticals, Terumo, Novartis, Sanwa Kagaku Kenkyusho, and Boehringer Ingelheim and has received honoraria or consulting fees from Tanabe-Mitsubishi, Sumitomo Farma, Eli Lilly, and Novo Nordisk. RC, SE, and MISK are employees of Novo Nordisk and hold stock in Novo Nordisk. CI provided advisory board services for Abbott, Ascensia, Menarini, Novo Nordisk, Roche Diabetes Care Italy, and Senseonics, and received speaker fees from Abbott, Ascensia, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. CM serves or has served on the advisory panel for ActoBio Therapeutics, AstraZeneca, Avotres, Boehringer Ingelheim, Eli Lilly, Imcyse, Insulet, MannKind, Medtronic, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, Roche, Sandoz, Sanofi, Vertex, and Zealand Pharma; financial compensation for these activities has been received by KU Leuven (Leuven, Belgium). KU Leuven reports research support for CM from ActoBio Therapeutics, Imcyse, Medtronic, Novo Nordisk, and Sanofi. CM serves or has served on the speakers' bureau for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, and Sanofi; financial compensation for these activities has been received by KU Leuven. JR has served on scientific advisory boards and received honorarium or consulting fees from Applied Therapeutics, Biomea Fusion, Boehringer Ingelheim, Eli Lilly, Hanmi, Intarcia, Novo Nordisk, Oramed, Sanofi, Scholar Rock, Structure Therapeutics, Terns Pharmaceuticals, and Zealand, and has received research support from Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi, Novartis, Merck, Novo Nordisk, Oramed, Pfizer, and Sanofi. VW has acted as a consultant for Novo Nordisk and received speaker fees from Novo Nordisk. DCK has acted as a consultant for Better Therapeutics, EOFlow, Integrity, Lifecare, Nevro, Novo Nordisk, Sanofi, and Thirdwayv.