Patients with type 2 diabetes receiving once-weekly insulin icodec were more likely to reach a hemoglobin A1C level below 7% compared to those who received once-daily insulin analogues.
Individuals with type 2 diabetes (T2D) who were treated with insulin icodec (Novo Nordisk) achieved a statistically significant decrease in hemoglobin A1C (HbA1C) compared to patients treated with once-daily insulin analogues, according to results from the ONWARDS 1 and 3 studies. Both trials achieved all primary and secondary endpoints, and reduced injections from 7 to 1 per week compared with once-daily basal insulin formulations.
Insulin icodec is an investigational insulin analogue designed to cover basal insulin requirements for a full week with a single subcutaneous injection. It has been evaluated in 6 phase 3a global clinical trials. The results of ONWARDS 1 and 3 were presented at the 83rd Annual Scientific Sessions of the American Diabetes Association (ADA).
ONWARDS 1 was a phase 3a, 78-week, open-label efficacy and safety treat-to-target trial comparing once-weekly insulin icodec with once-daily basal insulin glargine U100, both in combination with non-insulin anti-diabetic treatments, in 984 insulin-naïve adults with T2D. Investigators found that 52.6% of patients receiving once-weekly insulin icodec achieved a HbA1C target of <7% compared to 42.6% of patients receiving once-daily insulin glargine.
In addition, there were no statistically significant requirements in average weekly insulin dose (weeks 50-52) or in body weight change from baseline. Rates of significant hypoglycemia (defined as blood glucose <54 mg/dl) or severe hypoglycemia (symptomatic hypoglycemia requiring third party assistance) were low in both treatment groups.
A confirmatory secondary endpoint, Time in Range (blood glucose 70-180 mg/dl) was achieved in 71.9% of patients receiving insulin icodec compared to 66.9% of patients receiving insulin glargine U100. ONWARDS 3 was a phase 3a, 26-week, double-blind trial assessing the efficacy and safety of once-weekly insulin icodec in 588 insulin-naïve adults with T2D compared to once-daily insulin degludec, both in combination with non-insulin antidiabetic treatment.
The trial achieved the primary end point of change in HbA1C from baseline at week 26 compared to insulin degludec. There were no significant differences in mean weekly insulin dose from week 24 to 26 or body weight change from baseline between treatment arms. Additionally, investigators found that the estimated proportion of participants achieving a HbA1C <7% without clinically significant or severe hypoglycemia was significantly higher with once-weekly insulin icodec than with once-daily basal insulin degludec.
“These data reinforce our confidence in the potential of once-weekly insulin icodec,” said Florian M.M. Baeres, corporate vice president, Global Medical Affairs at Novo Nordisk, in a statement. “If approved, we believe this innovation-which could be the world’s first once weekly insulin-could help people living with type 2 diabetes ready to start insulin treatment by reducing the number of injections needed.”
Insulin icodec has been submitted for regulatory review in the United States, Canada, Europe, China, Australia, Switzerland and Brazil. First decisions are expected in 2024.
Novo Nordisk A/S: New data Show Once-Weekly Insulin Icodec Met Additional Endpoints in adults with Type 2 Diabetes in Phase 3a Trials. News release. Global News Wire. June 24,2023. Accessed on July 14, 2023. https://www.globenewswire.com/news-release/2023/06/24/2693998/0/en/Novo-Nordisk-A-S-New-data-show-once-weekly-insulin-icodec-met-additional-endpoints-in-adults-with-type-2-diabetes-in-phase-3a-trials.html