Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This outcome measure reports change from baseline to week 26 in HbA1c measured in terms of percentage point.
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 |
What the finished NCT04596631 record still lists
NCT04596631 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04596631's enrollment target sits among peer trials
132 184th of 348 higher than 165 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
RECRUITING · Phase 3
-
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01766297 · 132 participants · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- NCT04002947 · 132 participants · Phase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
- NCT04128189 · 132 participants · Phase 3
Shingrix in Renal Transplant Recipients
- NCT04199780 · 132 participants · NA
Effects of tDCS Combined With CBI on Postsurgical Pain
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI