The Phase 3 study (NCT04596631) investigating oral semaglutide for children and teenagers with Type 2 Diabetes reached its primary completion on 2025-04-29. This trial compared oral semaglutide to a placebo to assess its efficacy and safety in this pediatric population.
Background
The study, titled 'A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes,' aimed to evaluate oral semaglutide as a potential treatment for Type 2 Diabetes in pediatric patients. Semaglutide is being tested to determine its effectiveness and safety profile in this specific age group.
Trial design
The Phase 3 study (NCT04596631) was designed to compare oral semaglutide with a placebo in children and teenagers diagnosed with Type 2 Diabetes. The trial enrolled 132 participants, who were randomly assigned to receive either oral semaglutide or a dummy medicine (placebo). Participants took one tablet every morning on an empty stomach, waiting 30 minutes before eating, drinking, or taking other oral medications. The study duration was approximately 1 year and 3 months.
What this means
The primary completion of this Phase 3 trial signifies a key milestone in the development of oral semaglutide for pediatric Type 2 Diabetes. Data from this study will provide crucial insights into the potential role of oral semaglutide as a treatment option for children and teenagers, addressing an important unmet medical need. The results will inform future regulatory decisions and clinical practice regarding the use of this medication in a younger population.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04596631, titled 'A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes,' was updated on 2025-04-29 on clinicaltrials.gov.