The Denmark headquartered pharma group said it expects to file for regulatory approval of once-weekly insulin icodec in the US, the EU and China in the first half of 2023.
On Monday the company announced headline results from the ONWARDS 5 phase 3a trial with once-weekly insulin icodec in people with type 2 diabetes, a 52-week trial comparing once-weekly insulin icodec with once-daily basal insulin.
The objective of the study was to assess the effectiveness and safety of insulin icodec, with an app providing dosing recommendation, in 1,085 insulin-naïve people with type 2 diabetes in a clinical practice setting including no upper limit in terms of hemoglobin A1c (HbA1c) levels at time of inclusion, no limitations on use of oral antidiabetic treatments and fewer planned site visits compared to the other ONWARDS phase 3a trials.
Results
The trial achieved its primary endpoint, said the developer. It demonstrated non-inferiority in reducing HbA1c at week 52 with insulin icodec compared with once-daily basal insulin analogues. “From an overall baseline HbA1c of 8.9%, once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of –1.68%-points compared with –1.31%-points for the once-daily basal insulins.”
In the trial, there was no statistically significant difference in estimated rates of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 0.19 events per patient-year exposed to once-weekly insulin icodec and 0.14 events per patient-year exposed to the once-daily basal insulins. And the once-weekly insulin icodec appeared to have a safe and well-tolerated profile in the participants, said the Danish company.