October 03, 2022
Insulin icodec, once-weekly insulin, showed a superior reduction in HbA1C versus once-daily basal insulin.
Novo Nordisk announced the results of Phase 3a ONWARDS trial, demonstrating the superiority of once-weekly insulin icodec in reducing HbA1C versus once-daily basal insulin in people with type-2 diabetes.
The ONWARDS is a Phase 3 52-week, open-label study in 1,085 insulin naive people with type 2 diabetes. Once weekly, insulin icodec was administered with the help of a dosing guide app for titration.
The ONWARDS trial met the primary endpoint of demonstrating non-inferiority in the reduction of HbA1c at 52 weeks compared to once-daily basal insulin. From the baseline of 8.9% in HbA1c, insulin icodec showed superiority in reducing the estimated HbA1c by -1.68% versus -1.31% in patients on once-daily basal insulin.
There was no statistically significant difference in hypoglycemia between the two insulins.
Novo Nordisk announced that it will approach regulatory agencies of the US, the EU, and China in the first half of 2023 for approval of once-weekly insulin icodec.