Novel, once-weekly insulin icodec demonstrated superior reduction in glycated hemoglobin A1c (HbA1c) compared to insulin degludec in persons with type 2 diabetes mellitus (T2D), according to new findings from the 6-study ONWARDS clinical development program.
The new results are from ONWARDS 2, which is a phase 3a, 26-week efficacy and safety treat-to-target study analyzing how well once-weekly insulin icodec controls blood sugar compared to insulin degludec taken daily in 526 participants with T2D.
“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,” said Martin Holst Lange, executive vice president for development at Novo Nordisk, in an April 28, 2022, announcement.
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin icodec compared to insulin degludec, according to Novo Nordisk.
Results showed that from an overall baseline HbA1c of 8.13%, once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of 0.93% compared to 0.71% for insulin degludec (estimated treatment difference: -0.22%)
There was no statistical difference in estimated hypoglycemia rates, and no severe hypoglycemia events were observed for participants in the insulin icodec cohort, according to the press release.
The rates of severe or clinically significant hypoglycemia—defined for the purpose of the study as below 3 mmol/L—were 0.73 events per patient year exposed to insulin icodec and 0.27 events per patient-year exposed to insulin degludec. In addition, once-weekly insulin icodec had a safe and well-tolerated profile.
The ONWARDS clinical development program is currently comprised of 6 phase 3a global trials, including one with real-world elements and involving over 4000 adults with type 1 diabetes or T2D. Novo Nordisk said it expects to publish additional results from the program later this year.