April 23, 2026
1 min read
Key takeaways:
- The Ozempic pill reduced HbA1c by 0.83 percentage points more than placebo for youths with type 2 diabetes.
- The safety profile of Ozempic pill was similar to what was seen in previous trials.
Children and adolescents with type 2 diabetes had an improvement in HbA1c at 26 weeks with a once-daily oral GLP-1, according to topline results from the PIONEER TEENS phase 3a trial.
As Healio previously reported, oral semaglutide (Ozempic pill, Novo Nordisk) was approved by the FDA under the brand name Rybelsus as the first GLP-1 to treat type 2 diabetes for adults in 2019. According to a press release from Novo Nordisk, the PIONEER TEENS trial was the first to assess an oral GLP-1 for type 2 diabetes treatment in the pediatric population.
Children and adolescents with type 2 diabetes had a greater HbA1c reduction at 26 weeks with once-daily oral semaglutide compared with placebo. Image: Adobe Stock
In the trial, researchers enrolled 132 children and adolescents aged 10 to 17 years with type 2 diabetes. Participants were randomly assigned to once-daily oral semaglutide at a maximum tolerated dose of 3 mg, 7 mg or 14 mg or placebo for 1 year. All participants received background therapy with metformin, basal insulin or both.
At 26 weeks, youths receiving oral semaglutide had a 0.83-percentage point greater drop in HbA1c compared with placebo. According to the release, the safety profile of oral semaglutide was consistent with what was observed in prior trials of the drug.
“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,” Martin Holst Lange, chief scientific officer and executive vice president of research and development for Novo Nordisk, said in the release. “Oral semaglutide has already demonstrated clinically meaningful glycemic efficacy and a well-established safety profile in adults with type 2 diabetes, alongside proven cardiovascular benefits unique to this molecule. 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 glycemic control beyond that provided by the current standard of care.”
According to the release, Novo Nordisk plans to pursue FDA approval for a label expansion for the Ozempic pill in the second half of 2026.
Sources/Disclosures
Source:
Press Release
Disclosures:
Holst Lange is an employee of Novo Nordisk.
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