Novo Nordisk hits primary objectives of trials with once-weekly insulin icodec

 Novo Nordisk today announced headline results from the main phases of ONWARDS 1 (52 weeks) and ONWARDS 6 (26 weeks) phase 3a trials with once-weekly insulin icodec.

ONWARDS 1 (insulin naïve people with type 2 diabetes)
ONWARDS 1 is a phase 3a, 78-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin glargine U100 (insulin glargine), both in combination with non-insulin anti-diabetic treatment, in 984 insulin-naïve people with type 2 diabetes.

The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared to insulin glargine.

From an overall baseline HbA1c of 8.5% once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of -1.55% compared to -1.35% for insulin glargine (estimated treatment difference: -0.19%). Superior time in range (TIR) was also achieved for once-weekly insulin icodec compared to insulin glargine.

In the trial, there was no statistically significant difference in estimated rates of severe or clinically significant hypoglycaemia (blood glucose below 3mmol/L) with 0.30 events per patient year exposed to once-weekly insulin icodec and 0.16 events per patient-year exposed to insulin glargine. In the trial, once-weekly insulin icodec appeared to have a safe and well-tolerated profile.

https://finance.yahoo.com/news/novo-nordisk-achieves-primary-objectives-073000977.html