Once-weekly insulin icodec bests insulin degludec for HbA1c control in diabetics: ONWARDS 2 phase 3a trial

Once-weekly insulin icodec exhibited superior reduction of HbA1C to the tune of 0.22% compared with insulin degludec in people with type 2 diabetes after 26 weeks of treatment, according to Novo Nordisk's phase IIIa ONWARDS 2 trial.

Novo Nordisk today announced headline results from the ONWARDS 2 trial, a phase 3a, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec in 526 people with type 2 diabetes switching from daily insulin.

The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin icodec compared to insulin degludec.

From an overall baseline HbA1c of 8.13%, once-weekly insulin icodec achieved a superior reduction in estimated HbA1 c of 0.93% compared to 0.71% for insulin degludec (estimated treatment difference: -0.22%).

In the trial, there was no statistical difference in estimated hypoglycaemia rates, and no severe hypoglycaemia events were observed for people treated with insulin icodec. The rates of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) were 0.73 events per patient year exposed to once-weekly insulin icodec and 0.27 events per patient-year exposed to insulin degludec. In the trial, once-weekly insulin icodec appeared to have a safe and well-tolerated profile.

"We are very pleased with the results seen in ONWARDS 2, and once-weekly insulin icodec is the first insulin to demonstrate the ability to reduce the number of yearly basal insulin injections from 365 to 52 in a phase 3 trial", says Martin Holst Lange, executive vice president for Development at Novo Nordisk.

"Novo Nordisk has for 100 years been committed to develop insulin treatment to improve glycaemic outcome and reduce the disease burden for people living with diabetes and we are excited to share additional results of the ONWARDS programme later this year."

The ONWARDS clinical development programme for once-weekly insulin icodec currently comprises six phase 3a global clinical trials, including a trial with real-world elements, involving more than 4,000 adults with type 1 or type 2 diabetes.