Headline results from PIONEER 10, a Phase IIIa trial with oral semaglutide versus once-weekly subcutaneous dulaglutide, both in combination with one oral antidiabetic drug in Japanese adults with type 2 diabetes, Danish diabetes care giant Novo Nordisk (NOV: N) announced today.
Oral semaglutide is an investigational GLP-1 analogue taken once daily as a tablet. The trial investigated the safety, tolerability and efficacy of 3, 7 and 14mg oral semaglutide compared with 0.75mg once-weekly dulaglutide (Eli Lilly’ [NYSE: LLY] Trulicity) in 458 Japanese people with type 2 diabetes. Prior to enrolment, participants were inadequately controlled on one oral antidiabetic drug.
The trial achieved its primary objective by demonstrating a comparable number of adverse events with oral semaglutide compared to 0.75mg dulaglutide. The proportion of people treated with 3, 7 and 14mg oral semaglutide who experienced gastrointestinal adverse events were 31%, 39% and 54%, respectively, compared to 40% with dulaglutide; the most frequently reported events being constipation and nausea. The proportion of people who discontinued treatment due to adverse events was between 3% and 6% of people treated with oral semaglutide, compared to 3% of people treated with dulaglutide.
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