Weekly insulin-icodec exhibits Superior reduction of HbA1c compared to insulin degludec in two trials

Novo Nordisk today announced headline results from the ONWARDS 3 and ONWARDS 4 phase 3a trials with once-weekly insulin icodec in adults with type 2 diabetes.

ONWARDS 3 (insulin-naïve people with type 2 diabetes) ONWARDS 3 is a phase 3a, double-blind 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec. Both are in combination with non-insulin anti-diabetic treatment in 588 people with type 2 diabetes who have not previously been treated with insulin.

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

From an overall baseline HbA1c of 8.5%, once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of-1.57% compared with-1.36% for insulin degludec (estimated treatment difference:-0.21%).

In the trial, there was no statistically significant difference in estimated rates of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 0.31 events per patient-year exposed to once-weekly insulin icodec and 0.15 events per patient-year exposed to insulin degludec. In the trial, once-weekly insulin icodec appeared to have a safe and well-tolerated profile.

ONWARDS 4 (basal-bolus treatment in people with type 2 diabetes)ONWARDS 4 is a phase 3a, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin glargine U100, both in combination with mealtime insulin (insulin aspart administered two to four times daily), in 582 people with type 2 diabetes.

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

From an overall baseline HbA1c of 8.3% once-weekly insulin icodec achieved a reduction in estimated HbA1c of –1.16% compared with –1.18% for insulin glargine (estimated treatment difference: 0.02%).

In the trial, there was no statistically significant difference in estimated rates of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 5.64 events per patient-year exposed to once-weekly insulin icodec and 5.62 events per patient-year exposed to insulin glargine. In the trial, once-weekly insulin icodec appeared to have a safe and well-tolerated profile.

"We are very pleased to see that the results from ONWARDS 3 and 4 reinforce the potential of once-weekly insulin icodec to simplify basal insulin therapy for people with type 2 diabetes as an ideal starter insulin and as an attractive option in combination with mealtime insulin", said Martin Holst Lange, executive vice president for Development at Novo Nordisk.

"We are now looking forward to sharing the results from ONWARDS 5 - the last remaining trial in the ONWARDS programme in the second half of this year".