In adults with type 2 diabetes, once-weekly administration of insulin icodec was associated with a superior reduction in HbA1c when compared with daily injection of insulin degludec, according to results from a phase 3a trial.
The 26-week, treat-to-target ONWARDS 2 trial (ClinicalTrials.gov Identifier: NCT04770532) compared the efficacy and safety of insulin icodec to insulin degludec, with or without non-insulin antidiabetic drugs, in 526 adults with type 2 diabetes. 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.
Findings demonstrated that treatment with insulin icodec met the primary endpoint demonstrating noninferiority in reducing HbA1c at week 26 compared with insulin degludec. Moreover, patients treated with insulin icodec achieved a superior reduction in estimated HbA1c of 0.93% from an overall baseline HbA1c of 8.13% compared with 0.71% for insulin degludec (estimated treatment difference: -0.22%).
Insulin icodec was found to be safe and well tolerated. The rates of severe or clinically significant hypoglycemia (blood glucose below 3mmol/L) were 0.73 events per patient-year with insulin icodec and 0.27 events per patient-year with insulin degludec.
“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.
Insulin icodec is currently being evaluated in the ONWARDS clinical development program, which consists of six phase 3a global clinical trials.
Once-weekly insulin icodec demonstrates superior reduction in HbA1c vs insulin degludec in people with type 2 diabetes in ONWARDS 2 phase 3a trial. News release. Novo Nordisk. Accessed April 28, 2022. https://www.globenewswire.com/news-release/2022/04/28/2431662/0/en/Once-weekly-insulin-icodec-demonstrates-superior-reduction-in-HbA1c-vs-insulin-degludec-in-people-with-type-2-diabetes-in-ONWARDS-2-phase-3a-trial.html