Novo Nordisk’s oral semaglutide demonstrates potential to be the first oral GLP-1 RA therapy for children and adolescents with type 2 diabetes
Summary by AI BETAClose X
- 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 .
About oral semaglutide in type 2 diabetes
Oral semaglutide in type 2 diabetes (available today as Rybelsus® in the EU and US; launching in the US as Ozempic® pill later in Q2 2026) is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise. Oral semaglutide in type 2 diabetes is administered once daily. Two bioequivalent tablet formulations exist: 1.5 mg, 4 mg, and 9 mg (round tablets, second generation) and 3 mg, 7 mg, and 14 mg (oval tablets, first generation). In addition, 25 mg and 50 mg tablets are approved in the EU for type 2 diabetes7,8. Oral semaglutide offers superior blood glucose lowering versus multiple comparators9,10, together with consistent weight reduction9,10,11, reduction in cardiometabolic risk factors11 and reduction in major adverse cardiovascular events (MACE).12 Oral semaglutide is not currently approved for use in children or adolescents.
Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 68,800 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
Contacts for further information
| Novo Nordisk Media: | |
| Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com | Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com |
| Novo Nordisk Investors: | |
| Michael Novod +45 3075 6050 nvno@novonordisk.com | Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com |
| Sina Meyer +45 3079 6656 azey@novonordisk.com | Max Ung +45 3077 6414 mxun@novonordisk.com |
| Christoffer Sho Togo Tullin +45 3079 1471 cftu@novonordisk.com | Alex Bruce +45 3444 2613 axeu@novonordisk.com |
| Mads Berner Bruun +45 3075 2936 mbbz@novonordisk.com | Frederik Taylor Pitter +1 609 613 0568 fptr@novonordisk.com |
_______________________
References
- Perng W, et al. Diabetes Care. 2023;46(3):490-9
- Wu H, et al. Diabetes Res Clin Pract. 2022 Mar;185:109785
- Chen X, et al. BMC Med. 2025 Jan 29;23(1):48
- Shah AS, et al. Horm Res Paediatr. 2024;97(6):555-583
- American Diabetes Association Professional Practice Committee for Diabetes-2026. Diabetes Care 1 January 2026; 49 (Supplement_1): S297–S320
- ClinicalTrials.gov. A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes (PIONEER TEENS). Available at: https://clinicaltrials.gov/study/NCT06221969. Last accessed: April 2026
- Rybelsus® (oral semaglutide): US Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf. Last accessed: April 2026
- Rybelsus® (oral semaglutide): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rybelsus. Last accessed: April 2026
- Rosenstock J, et al. JAMA. 2019;321(15):1466-1480.
- Rodbard HW, et al. Diabetes Care. 2019;42(12):2272-2281.
- Husain M, et al. N Engl J Med. 2019;381(9):841-851.
- McGuire DK, et al. N Engl J Med. 2025;392(20):2001-2012.
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