Novo Nordisk’s insulin icodec has continued to demonstrate positive results as a once-weekly treatment for adults with type 2 diabetes, according to new data from a phase 3a trial in 1,085 insulin-naïve patients.
Insulin icodec is a novel once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. Currently, the basal insulin products with the longest duration are injected once daily.
The ONWARDS 5 trial was a 52-week, open-label efficacy and safety treat-to-target trial investigating once-weekly insulin versus once-daily basal insulin (insulin degludec or insulin glargine).
The trial achieved its primary endpoint of demonstrating 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.
Moreover, the company reported no statistically significant difference in estimated rates of severe or clinically significant hypoglycaemia across the trial groups, with once-weekly insulin icodec appearing to have a safe and well-tolerated profile.
The announcement follows positive results from another phase 3a trial of insulin icodec in patients with type 2 diabetes, which the company presented at the European Association for the Study of Diabetes last month.
More than 4.9 million people in the UK have diabetes, around 90% of which have type 2 diabetes, according to Diabetes UK. There is currently no cure for type 2 diabetes, with available treatment options focused on disease management, including diet and exercise, diabetes medications or insulin therapy.
Commenting on the positive results, Martin Holst Lange, executive vice president for development at Novo Nordisk, said: “We are very pleased to share the positive results from the ONWARDS 5 trial. These results include real-world elements and a dosing guide app, which help us better understand how insulin icodec can make a difference for patients in a clinical practice setting.
“Today’s results confirm the results from the previous reported ONWARDS trials and highlight that insulin icodec has the potential to be an ideal insulin for people with type 2 diabetes. We now look forward to sharing the results with regulatory authorities.”
The company noted that it expects to file for regulatory approval of once-weekly insulin icodec in the EU, the US and China in the first half of 2023.