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NCT04596631 · ClinicalTrials.gov registry record · Phase 3
A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT04596631 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 132 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT04596631, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
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.
NCT04596631 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, Texas, Georgia.
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.
What interventions are being tested in trial NCT04596631?
The interventions under investigation include: Placebo (semaglutide) (DRUG), Oral semaglutide (DRUG).
Who is sponsoring clinical trial NCT04596631?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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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