Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
NCT04596631 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Placebo (semaglutide)
- DRUG Oral semaglutide
Study Locations (20)
Florida
- Nemours Chld Clnc Jacksonville — Jacksonville
- Nemours Children's Health — Pensacola
- University of South Florida Diabetes Center — Tampa
Texas
- Texas Tech University HSC — Amarillo
- Univ Of Texas Hlth Science Cntr — San Antonio
- NE Clin Res of San Antonio — San Antonio
Georgia
- Children's Healthcare Atlanta — Atlanta
- Columbus Research Foundation — Columbus
Alabama
- UAB Ped Endo Children's Hosp — Birmingham
California
- Children's Hospital Los Angeles - Endocrinology — Los Angeles
Connecticut
- Yale School Of Medicine — New Haven
Indiana
- Indiana Uni School of Med-Ped — Indianapolis
Kentucky
- University Of Louisville Research Foundation — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2026-02-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04596631
The ClinicalTrials.gov registry entry for NCT04596631 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions — of which Placebo (semaglutide) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04596631 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Texas, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04596631 about?
NCT04596631 is a clinical study titled "A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes". 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 ...
What is the current status of trial NCT04596631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2020-11-02. Estimated completion is 2026-02-03.
What conditions does trial NCT04596631 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04596631?
The interventions under investigation include: Placebo (semaglutide) (DRUG), Oral semaglutide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04596631?
This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04596631 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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