Novo Nordisk’s oral semaglutide demonstrates potential to be the first oral GLP-1 RA therapy for children and adolescents with type 2 diabetes
PIONEER TEENS is the first clinical trial of an oral GLP-1 RA therapy in children and adolescents aged 10–17 years with type 2 diabetes, addressing a significant unmet need.
The trial demonstrated a statistically significant and superior reduction in blood sugar by 0.83% vs placebo at 26 weeks.
Novo Nordisk expects to file for regulatory approval of a label expansion for Ozempic® pill and Rybelsus® in the US and EU in the second half of the year.
Bagsværd, Denmark, 23 April 2026 – Novo Nordisk today announced positive topline results from PIONEER TEENS, a phase 3a trial evaluating oral semaglutide for type 2 diabetes in children and adolescents aged 10–17 years with type 2 diabetes. Oral semaglutide demonstrated a superior reduction in HbA1c (a measure of blood sugar control) over placebo in the trial and showed a well-tolerated safety profile consistent with previous Novo Nordisk semaglutide trials. Oral semaglutide is available today 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. Current management for glycaemic control in youth-onset type 2 diabetes remains constrained, and there is an unmet need for more treatment options. In 2021, 14.6 million adolescents were living with type 2 diabetes globally. By 2030, this number is projected to increase to 20.9 million1-3.
Current guidelines recommend metformin and insulin as first-line treatments4,5 ; however, metformin is associated with failure in glycaemic control in approximately half of adolescents13, and insulin is associated with hypoglycaemia and weight gain4,5. This is the first clinical trial of an oral GLP-1 RA therapy in this age group, addressing a critical unmet need. Pending regulatory approvals, oral semaglutide has the potential to be the first and only oral GLP-1 RA to demonstrate superior glycemic efficacy versus placebo in children and adolescents with type 2 diabetes, while maintaining the well-established safety profile seen across the semaglutide portfolio.
About the PIONEER TEENS Trial
PIONEER TEENS (NCT04596631) was a 52-week, randomised, double-blind, placebo-controlled phase 3a trial evaluating oral semaglutide at maximum tolerated doses (3 mg, 7 mg, or 14 mg once daily) vs placebo in 132 children and adolescents aged 10–17 years with type 2 diabetes. The participants received background treatment with metformin, basal insulin or both. The primary endpoint was change from baseline to week 26 in HbA1c6 .
Quelle:
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