Once-weekly insulin icodec better than once-daily insulin glargine for patients with type 2 diabetes: ONWARDS 4 trial
Belgium: Once-weekly insulin icodec performed equally well as once-daily insulin glargine U100 for glycemic control, required fewer basal insulin injections, and a lower bolus insulin dose with no increase in hypoglycaemic rates in type 2 diabetes patients, according to ONWARDS 4 trial. The trial findings were published in The Lancet on May 05, 2023.
Insulin icodec (icodec) is a basal insulin analogue appropriate for once-weekly dosing. Prof Chantal Mathieu, Catholic University of Leuven, Leuven, Belgium, and colleagues aimed to evaluate the safety and efficacy of once-weekly icodec versus once-daily insulin glargine U100 (glargine U100) in patients with long-standing type 2 diabetes on a basal-bolus regimen in the ONWARDS 4 trial. ONWARDS 4 is a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial.
The trial, conducted for 26 weeks, involved adults from 80 sites across nine countries (the USA, Russia, Romania, the Netherlands, Mexico, Japan, Italy, India, and Belgium). Five hundred eighty-two participants were randomly assigned in a ratio of 1:1 to receive once-weekly icodec (n=291) or glargine U100 (n=291) combined with 2–4 daily bolus insulin aspart injections.
Safety outcomes were assessed in the safety analysis set that comprised all participants randomly allocated to receive at least one dose of the trial product. The study's primary outcome was a change in HbA1c from baseline to week 26 (non-inferiority margin of 0·3 percentage points), evaluated in the complete analysis set, i.e. all randomly assigned participants. The mean duration of the participants with type 2 diabetes of 17·1 year.
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