Full PIONEER TEENS Results Posted: Oral Semaglutide Lowered HbA1c in Adolescents With Type 2 Diabetes

ClinicalTrials.gov posted the complete results of PIONEER TEENS on August 21, 2026, a phase 3, randomized, double-blind, placebo-controlled trial testing oral semaglutide in children and adolescents with type 2 diabetes. Novo Nordisk, which sponsors the trial and manufactures semaglutide, first announced topline findings in a press release on April 23, 2026; the detailed dataset, including full safety data not disclosed at the time of that announcement, was submitted to the registry on April 29, 2026 and cleared the registry's quality-control review before posting publicly this week. The trial is registered as NCT04596631 and, in the European Union, as EudraCT 2018-002952-34.

The trial enrolled 132 participants aged 10 to below 18 years with type 2 diabetes diagnosed under American Diabetes Association criteria, a baseline HbA1c between 6.5% and 11.0%, and a stable background dose of metformin, basal insulin, or both. Participants were randomized 1:1 to once-daily oral semaglutide tablets, dose-escalated from a 3 mg starting dose up to a maximum tolerated dose of 7 mg or 14 mg, or matching placebo, both added to background therapy, for a 52-week treatment period followed by a 12-week off-treatment follow-up. Novo Nordisk describes PIONEER TEENS as the first clinical trial of an oral GLP-1 receptor agonist in this age group.

At week 26, the trial's primary endpoint, mean HbA1c fell by 1.0 percentage point (standard deviation 1.5) in the oral semaglutide group compared with 0.3 percentage point (standard deviation 1.3) in the placebo group. At week 52, HbA1c fell by 0.8 percentage point (standard deviation 1.4) with oral semaglutide versus a 0.2 percentage point increase (standard deviation 1.4) with placebo. Novo Nordisk's April announcement separately reported a statistically significant, model-estimated treatment difference of 0.83 percentage points favoring oral semaglutide at week 26. Sixty-four of 66 participants randomized to oral semaglutide completed the trial, compared with all 66 randomized to placebo.

Adverse events of any kind were reported in 45 of 66 participants (68%) on oral semaglutide and 40 of 66 (61%) on placebo, with gastrointestinal events, including nausea, diarrhea, and abdominal pain, the most common category. Serious adverse events occurred in 5 participants (7.6%) on oral semaglutide, including single cases of aggression, anaphylactic reaction, arthritis, and gastroenteritis, and in 2 participants (3.0%) on placebo, including a cerebral venous sinus thrombosis and a case of pneumonia. There were no deaths in either arm. Severe or blood-glucose-confirmed symptomatic hypoglycemia was reported in 1 participant (3 episodes) on oral semaglutide compared with 6 participants (13 episodes) on placebo, both groups on background insulin or metformin therapy.

Oral semaglutide is approved by the FDA as Rybelsus and by regulators in the European Union and Australia for adults with type 2 diabetes; it does not currently have a pediatric indication in any of those markets. In the April announcement, Novo Nordisk said it expects to file with the FDA and European Medicines Agency for a label expansion covering children and adolescents with type 2 diabetes in the second half of 2026, based on the PIONEER TEENS results. That filing has not been confirmed as submitted, and any pediatric approval remains pending regulatory review. The results describe outcomes observed in this trial population and are not treatment or dosing guidance; care for pediatric type 2 diabetes should be directed by a qualified clinician.