Data from Phase IIIa ONWARDS 1 and 3 trials have shown that more insulin-naïve adults with type 2 diabetes (T2D) achieved an HbA1c target of less than 7% with once-weekly basal insulin icodec compared to the once-daily basal insulin comparators.
The data presented at the Annual Scientific Sessions of the American Diabetes Association (ADA) in San Diego (US) showed that ONWARDS I and III trials met their primary endpoints and reduced the injection need for basal insulin icodec from seven times per week to once weekly.
Insulin icodec is currently under regulatory review in multiple countries, including the US, Canada, Europe, China, Australia, and Brazil, with decisions expected in the first half of 2024.
Novo Nordisk is a current and future leader in the T2D drug space, as per GlobalData forecasts. Its type 2 diabetes portfolio include Victoza (liraglutide), Ozempic (semaglutide), Rybelsus (oral semaglutide), and Tresiba (insulin degludec).
GlobalData is the parent company of Clinical Trials Arena.
ONWARDS I trial data
The open-label, randomised, active comparator Phase III trial (NCT04460885) compared the safety and efficacy of once-weekly insulin icodec with once-daily insulin glargine 100 units per millilitre (U100).
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52.6% and 42.6% of participants on the once-weekly basal insulin icodec and once-daily basal insulin glargine U100, respectively, had reduced HbA1c levels to 7% or lower.
The time in range for normal glucose (70mg/dL–180mg/dL) was achieved by 71.9% of the participants in the once-weekly basal insulin icodec compared to 66.9% of participants on once-daily basal insulin glargine U100. However, the hypoglycaemia rates were similar for both treatment options.
Lead trial investigator Dr Julio Rosenstock justified the need for having time in the normal glucose range as a secondary endpoint to provide additional information for assessing glycaemic control.
ONWARDS III trial data
The double-blind, randomised active comparator Phase III trial (NCT04795531) compared the safety and efficacy of once-weekly insulin icodec with once-daily Tresiba (insulin degludec).
More participants in the once-weekly basal insulin icodec compared to Tresiba group had reduced HbA1c levels to 7% or lower.
The severe/clinically significant hypoglycaemia rates were 0.31 and 0.15 events per patient-year exposure to insulin icodec and Tresiba, respectively.