Novo Nordisk reports results of PIONEER 3 trial of oral semaglutide

Presented at the Endocrine Society Annual Meeting in New Orleans, Louisiana, with simultaneous publication in the Journal of the American Medical Association, PIONEER 3 was a phase 3a trial investigating the efficacy and long-term safety of oral semaglutide 3 mg, 7 mg and 14 mg compared with sitagliptin 100 mg in adults with type 2 diabetes inadequately controlled with metformin, with or without sulfonylurea, over 78 weeks. Oral semaglutide 7 mg and 14 mg demonstrated superior HbA1c and body weight reductions compared to Januvia, Novo Nordisk reports. Non-inferiority for oral semaglutide 3 mg for HbA1c reductions at 26 weeks was not confirmed. In PIONEER 3, the primary endpoints of HbA1c and confirmatory secondary endpoint of change in body weight were assessed after 26 weeks of treatment. When applying the primary statistical approach[a], oral semaglutide 7 mg and 14 mg demonstrated superior HbA1c reductions of 1.0% and 1.3% at 26 weeks, compared to a 0.8% reduction with sitagliptin. Oral semaglutide 3 mg demonstrated a reduction in HbA1c of 0.6%; non-inferiority compared to sitagliptin was not confirmed. Furthermore, at 26 weeks, oral semaglutide 7 mg and 14 mg demonstrated superior body weight reductions of 2.2 kg and 3.1 kg, both compared to a 0.6 kg reduction for sitagliptin. When applying the secondary statistical approach[b] at week 26, oral semaglutide 7 mg and 14 mg demonstrated statistically significant reductions in HbA1c of 1.1% and 1.4%, respectively, compared to a 0.8% reduction with sitagliptin. Reductions in HbA1c seen with oral semaglutide 3 mg were 0.5% and compared to the reductions seen with sitagliptin, the difference is statistically significant in favor of sitagliptin. Reductions in body weight from baseline were statistically significant in favor of all three oral semaglutide doses. “Many people living with type 2 diabetes do not meet their blood glucose targets despite many available oral antidiabetic therapies,” said Dr Dale Allison, PIONEER 3 investigator and director of medical research at the Hillcrest Family Health Center, Waco, Texas. “The PIONEER 3 findings are encouraging, as oral semaglutide demonstrated a clinically significant improvement in HbA1c and this investigational therapy has the potential to become the first oral GLP-1 receptor agonist for those living with type 2 diabetes.”

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