A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
Public ClinicalTrials.gov record NCT04596631. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04596631
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 1, 2020
- Primary completion
- Apr 28, 2025
- Completion
- Feb 2, 2026
- Last update posted
- Aug 20, 2026
2020 – 2026
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Ped Endo Children's Hosp | Birmingham | Alabama | 35233 | — |
| Children's Hospital Los Angeles - Endocrinology | Los Angeles | California | 90027 | — |
| Yale School Of Medicine | New Haven | Connecticut | 06520 | — |
| Nemours Chld Clnc Jacksonville | Jacksonville | Florida | 32207 | — |
| Nemours Children's Health | Pensacola | Florida | 32514 | — |
| University of South Florida Diabetes Center | Tampa | Florida | 33612 | — |
| Children's Healthcare Atlanta | Atlanta | Georgia | 30329 | — |
| Columbus Research Foundation | Columbus | Georgia | 31904 | — |
| Indiana Uni School of Med-Ped | Indianapolis | Indiana | 46202 | — |
| University Of Louisville Research Foundation | Louisville | Kentucky | 40202 | — |
| Pennington Biomed Res Ctr | Baton Rouge | Louisiana | 70808-4124 | — |
| Barry J. Reiner, MD LLC | Baltimore | Maryland | 21229 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| UBMD Peds-Div of Endo/Diabetes | Buffalo | New York | 14203 | — |
| UPMC Child Hosp-Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Monument Health Clinical Rsrch | Rapid City | South Dakota | 57701 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Tech University HSC | Amarillo | Texas | 79106 | — |
| Univ Of Texas Hlth Science Cntr | San Antonio | Texas | 78207 | — |
| NE Clin Res of San Antonio | San Antonio | Texas | 78233 | — |
| Pediatric Endo UVHS | Charlottesville | Virginia | 22908 | — |
| Virginia Commonwealth University_Richmond | Richmond | Virginia | 23298 | — |
| Virginia Commonwealth Univ | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04596631, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04596631 live on ClinicalTrials.gov.