3 Jul 2023 • The investigational once-weekly insulin icodec provided superior glucose control compared with the once-daily basal insulins degludec and glargine in type 2 diabetes, results from two new phase 3a studies suggest. A decision from the FDA is expected in April 2024. If approved, it will be the world’s first once-weekly insulin. The results of the trials were presented at the 83rd Scientific Sessions of the American Diabetes Association.

• The ONWARDS 1 trial, compared once-weekly icodec with once-daily glargine, and ONWARDS 3 trial, compared once-weekly icodec with daily degludec, both in insulin-naive patients with type 2 diabetes.
• In both trials, primary endpoints of superiority and noninferiority in A1c reduction were achieved, and in ONWARDS 1, patients spent more time in target blood glucose range.
• Glycemic control was significantly better with once-weekly insulin icodec than with once-daily insulin glargine U100
• The data from ONWARDS 1 was published in the New England Journal of Medicine, and that from ONWARDS 3 was published in JAMA.
• In summary, these two studies support icodec as an effective and safe basal insulin that will require fewer injections for those with T2D. Although the rate of minor hypoglycemia is somewhat higher, significant hypoglycemia is not greater than that of the comparators

Six ONWARDS trials make up the drugmakers phase 3a clinical development program comparing the efficacy and safety of once-weekly insulin icodec with once-daily basal insulin comparators.

Source: NEJM | ONWARDS 1 TRIAL JAMA | ONWARDS 3 TRIAL