Treatment with once-weekly insulin icodec was associated with noninferior reductions in HbA1c in adults with type 2 diabetes when compared with daily injections of insulin degludec and insulin glargine, according to results from two phase 3a trials.
The 26-week, double-blind ONWARDS 3 trial compared the efficacy and safety of insulin icodec to insulin degludec with noninsulin antidiabetic treatment in 588 adults with type 2 diabetes who had not previously been treated with insulin. Patients received either insulin icodec subcutaneously (SC) once weekly or insulin degludec SC once daily for 26 weeks. The primary endpoint was the percent change in HbA1c.
Results from ONWARDS 3 showed that treatment with insulin icodec met the primary endpoint demonstrating noninferiority in reducing HbA1c at week 26 compared with insulin degludec. Patients treated with insulin icodec achieved a superior reduction in estimated HbA1c of 1.57%, from an overall baseline HbA1c of 8.5%, compared with 1.36% for insulin degludec (estimated treatment difference, -0.21%).
The 26-week ONWARDS 4 trial compared the efficacy and safety of insulin icodec to insulin glargine in combination with mealtime insulin (insulin aspart given 2 to 4 times daily) in 582 adults with type 2 diabetes. Patients received either insulin icodec SC once weekly or insulin glargine SC once daily for 26 weeks. The primary endpoint was the percent change in HbA1c.
In ONWARDS 4, treatment with insulin icodec met the primary endpoint demonstrating noninferiority in reducing HbA1c at week 26 compared with insulin glargine. Patients treated with insulin icodec achieved a reduction in estimated HbA1c of 1.16%, from an overall baseline HbA1c of 8.3%, compared with 1.18% for insulin glargine (estimated treatment difference, 0.02%).
Insulin icodec was found to be safe and well tolerated in both trials. No statistically significant differences in estimated rates of severe or clinically significant hypoglycemia were observed between the treatment groups.
“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 program in the second half of this year.”
The ONWARDS clinical development program consists of six phase 3a global clinical trials.
Novo Nordisk achieves primary objectives of ONWARDS 3 and 4 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin degludec in ONWARDS 3. News release. Novo Nordisk. Accessed July 29, 2022. https://www.globenewswire.com/news-release/2022/07/29/2488672/0/en/Novo-Nordisk-achieves-primary-objectives-of-ONWARDS-3-and-4-trials-with-once-weekly-insulin-icodec-demonstrating-superior-reduction-in-HbA1c-vs-insulin-degludec-in-ONWARDS-3.html