Trials / Completed
CompletedNCT04596631
A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
Efficacy and Safety of Oral Semaglutide Versus Placebo Both in Combination With Metformin and/or Basal Insulin in Children and Adolescents With Type 2 Diabetes
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 10 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral semaglutide | Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose. |
| DRUG | Placebo (semaglutide) | Placebo treatment for 52 weeks. |
Timeline
- Start date
- 2020-11-02
- Primary completion
- 2025-04-29
- Completion
- 2026-02-03
- First posted
- 2020-10-22
- Last updated
- 2026-03-11
Locations
97 sites across 22 countries: United States, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04596631. Inclusion in this directory is not an endorsement.