Positive topline results from Novo Nordisk’s PIONEER TEENS, a Phase IIIa trial evaluating oral semaglutide for type 2 diabetes demonstrated a superior reduction in HbA1c (a measure of blood sugar control) over placebo. 

The trial, in children and adolescents aged 10–17 years with type 2 diabetes, also showed a well-tolerated safety profile consistent with previous Novo Nordisk semaglutide trials.  

Oral semaglutide is sold as Rybelsus in the EU and US and will be available in the US as Ozempic pill soon. 

“Over the past two decades, the prevalence of type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need. Oral semaglutide has already demonstrated clinically meaningful glycaemic efficacy and a well-established safety profile in adults with type 2 diabetes, alongside proven cardiovascular benefits unique to this molecule,” said Martin Holst Lange, Chief Scientific Officer and Executive Vice President, Research & Development, at Novo Nordisk.  

“These results from the PIONEER TEENS trial confirm that oral semaglutide is an effective treatment option for children and adolescents with type 2 diabetes who require glycaemic control beyond that provided by the current standard of care.” 

Type 2 diabetes in children and adolescents is a severe and progressive condition that is strongly associated with increased risks of early mortality in adulthood. In 2021, 14.6 million adolescents were living with type 2 diabetes globally. By 2030, this number is projected to increase to 20.9 million. 

Current guidelines recommend metformin and insulin as first-line treatments; however, metformin is associated with failure in glycaemic control in approximately half of adolescents, and insulin is associated with hypoglycaemia and weight gain. This is the first clinical trial of an oral GLP-1 RA therapy in this age group.