Source – Novo Nordisk
Novo Nordisk, on June 25, 2023, released new findings from Phase IIIa trials, ONWARDS 1 and ONWARDS 3, evaluating the investigational once-weekly basal insulin icodec. These results were presented at the 83rd Annual Scientific Sessions of the American Diabetes Association (ADA). The data demonstrated that the trials achieved their primary endpoints while significantly reducing the number of injections from seven to just one per week compared to once-daily basal insulin. Moreover, the studies revealed that a greater number of insulin-naïve adults with type 2 diabetes treated with once-weekly basal insulin icodec achieved the target HbA1c level of less than 7.0% without experiencing clinically significant or severe hypoglycemia, compared to those on once-daily basal insulin, at 52 and 26 weeks, respectively.
”Time in Range provides additional information to help us assess glycaemic control and is an increasingly important tool to complement HbA1c measurements, which were substantially reduced by once-weekly basal insulin icodec. In ONWARDS 1, insulin icodec allowed people to spend significantly more Time in Range, with comparable Time below Range vs once-daily basal insulin glargine U100. A once-weekly basal insulin can potentially change how we treat people with type 2 diabetes needing basal insulin replacement.”
– Dr Julio Rosenstock, Lead Trial Investigator and Director of Velocity Clinical Research at Medical City Dallas and Clinical Professor of Medicine, University of Texas Southwestern Medical Center, US
In the ONWARDS 1 trial, as a confirmatory secondary endpoint, it was found that once-weekly basal insulin icodec performed better than once-daily basal insulin glargine U100 in terms of Time in Range (blood glucose levels between 70-180 mg/dL), with a rate of 71.9% versus 66.9% from week 48 to 52. Comparable rates of Time below Range (blood glucose below 54 mg/dL) were observed between once-weekly basal insulin icodec and once-daily basal insulin glargine U100, at 0.3% and 0.2%, respectively, during the same period. Both values align with internationally recommended targets.
In ONWARDS 1, there were no significant differences in mean weekly insulin dose (week 50-52) or in changes in body weight compared to baseline. The incidence of clinically significant or severe hypoglycemia was low in both treatment groups, with rates of 0.30 events per patient-year exposed and 0.16 events per patient-year exposed for once-weekly insulin icodec and insulin glargine U100, respectively. More participants achieved the HbA1C target of less than 7% without clinically significant or severe hypoglycemia with once-weekly basal insulin icodec compared to once-daily basal insulin glargine U100, at 52.6% versus 42.6%, respectively.
In the ONWARDS 3 trial, rates of clinically significant or severe hypoglycemia were 0.31 events per patient-year exposed and 0.15 events per patient-year exposed for insulin icodec and insulin degludec, respectively, during weeks 0-31. The estimated proportion of participants achieving an HbA1C target of less than 7% without clinically significant or severe hypoglycemia was significantly higher with once-weekly basal insulin icodec than once-daily basal insulin degludec. There were no significant differences in mean weekly insulin dose or body weight changes between treatment groups, and no unexpected safety concerns were observed.
Insulin icodec has been submitted for regulatory review in multiple countries, including the US, Canada, Europe, China, Australia, Switzerland, and Brazil. The first decisions regarding approval are expected in the first half of 2024. Pending approval, insulin icodec has the potential to become the first and only once-weekly basal insulin option for adults with diabetes, addressing an unmet need for an alternative to daily basal insulin treatment.
