A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes

NCT04596631 · Completed

Last updated 2026-05-28

This study is testing a new oral diabetes medicine called semaglutide in children and teenagers with type 2 diabetes to see how it affects their blood sugar levels compared to a placebo.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 132 people

Who can join Ages 10–18 · all sexes

Timeline Started 2020-11 · est. completion 2026-02

Where 97 sites · Australia, Austria, Belgium, Czechia, Greece, India, Israel, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Portugal, Puerto Rico, Romania, Russia, Taiwan, Ukraine, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT04596631 ↗

Description as written by the study sponsor.

This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe in children and teenagers. Participants will either get semaglutide or the dummy medicine - which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.

Treatments tested

Oral semaglutide Drug

Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
Placebo (semaglutide) Drug

Placebo treatment for 52 weeks.

Main thing measured	Change from baseline in glycosylated haemoglobin (HbA1c)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04596631 ↗