April 23 (Reuters) - Novo Nordisk's oral GLP-1 drug met the main goal of a late-stage study in children and adolescents aged 10 to 17 years with type 2 diabetes, the drugmaker said on Thursday. (
Novo Nordisk's diabetes pill cuts blood sugar in key trial in children
Breakthrough Results from Novo Nordisk's Oral GLP-1 Drug Trial
Significant Blood Sugar Reduction Achieved
April 23 (Reuters) - Novo Nordisk's oral GLP-1 drug significantly lowered blood sugar levels in children and adolescents with type 2 diabetes, meeting the main goal of a late‑stage trial, the drugmaker said on Thursday.
Details of the Clinical Study
Patient Demographics and Study Duration
The Danish drugmaker tested the pill in 132 patients aged 10 to 17 over a 26‑week period.
Statistical Outcomes
The study showed that patients taking the drug lowered their average blood sugar levels by 0.83 percentage points more than those given a placebo, a difference the company said was "statistically significant".
Background and Context
First Oral GLP-1 Therapy Trial in Young Patients
The trial is the first to test an oral GLP‑1 therapy, a drug class best known for blockbuster treatments for diabetes and weight loss, in children and adolescents.
Rising Prevalence of Type 2 Diabetes in Youth
Type 2 diabetes, once considered a disease of adults, is increasingly being diagnosed in younger people. About 364,000 children and adolescents under the age of 20 in the United States are living with diagnosed diabetes, according to the Centers for Disease Control and Prevention.
Treatment Landscape for Pediatric Type 2 Diabetes
Current Treatment Limitations
Treatment options for young patients remain limited. Doctors typically rely on metformin or insulin, but metformin fails to control blood sugar in roughly half of adolescent patients, while insulin carries risks such as low blood sugar and weight gain.
Potential for Regulatory Approval
No oral GLP‑1 therapy has ever been approved for use in children or teenagers. Novo Nordisk’s pill could become the first.
Future Prospects and Industry Impact
Regulatory Plans
The company said it plans to apply in the second half of 2026 for regulatory approval to expand the label for its oral semaglutide drugs, Ozempic pill and Rybelsus, in the United States and the European Union.
Market Implications
Extension of Semaglutide Franchise
Positive results in young patients could also extend Novo's semaglutide franchise beyond adults and strengthen its lead over rivals such as Eli Lilly in diabetes and weight‑loss treatments.
(Reporting by Mariam Sunny and Kamal Choudhury in Bengaluru; Editing by Sriraj Kalluvila and Devika Syamnath)
