\u201cOver 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,\u201d said Martin Holst Lange, chief scientific officer and executive vice president, Research & Development, at Novo Nordisk. \u201cThese 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.\u201d<\/p>\n
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.<\/p>\n
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.\u00a0This 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\u00a0safety profile seen across the semaglutide portfolio.<\/p>\n
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\u201317 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 .<\/p>\n
About oral semaglutide in type 2 diabetes 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<\/a>, Facebook<\/a>, Instagram<\/a>, X<\/a>, LinkedIn<\/a> and YouTube<\/a>.<\/p>\n Contacts for further information<\/p>\n _______________________ Perng W, et al. Diabetes Care. 2023;46(3):490-9Wu H, et al. Diabetes Res Clin Pract. 2022 Mar;185:109785Chen X, et al. BMC Med. 2025 Jan 29;23(1):48Shah AS, et al. Horm Res Paediatr. 2024;97(6):555-583American Diabetes Association Professional Practice Committee for Diabetes-2026. Diabetes Care 1 January 2026; 49 (Supplement_1): S297\u2013S320ClinicalTrials.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.<\/a> Last accessed: April 2026Rybelsus\u00ae\u00a0(oral semaglutide): US Prescribing Information. Available at: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/213051s023lbl.pdf<\/a>. Last accessed: April 2026Rybelsus\u00ae\u00a0(oral semaglutide): Summary of Product Characteristics. Available at: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/rybelsus<\/a>. Last accessed: April 2026Rosenstock 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. <\/p>\n
Oral semaglutide in type 2 diabetes (available today as Rybelsus\u00ae in the EU and US; launching in the US as Ozempic<\/a>\u00ae<\/a> pill later in Q2 2026<\/a>) 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\u00a0offers superior blood glucose lowering versus multiple comparators9,10, together with consistent weight reduction9,10,11, reduction in cardiometabolic risk factors11\u00a0and reduction in major adverse cardiovascular events (MACE).12 Oral semaglutide is not currently approved for use in children or adolescents.<\/p>\n
References<\/p>\n
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