Phase III ONWARDS 1 and 6 trials of weekly insulin icodec met primary endpoints in type 2 diabetes.- Novo Nordisk

ONWARDS 1 (insulin naïve people with type 2 diabetes) 1 is a phase IIIa, 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.

ONWARDS 6 (basal-bolus treatment in people with type 1 diabetes). ONWARDS 6 is a phase IIIa, 52-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec, both in combination with three daily mealtime insulin injections, in 582 people with type 1 diabetes. 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 7.6%, once-weekly insulin icodec achieved a reduction in estimated HbA1c of -0.47% compared to -0.51% for insulin degludec (estimated treatment difference: 0.05%). In the trial, there was a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 19.93 events per patient year exposed to once-weekly insulin icodec and 10.37 events per patient-year exposed to insulin degludec. In the trial, once-weekly insulin icodec appeared to have a safe and well-tolerated profile.