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Completed Phase 3 Interventional

A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes

ClinicalTrials.gov ID: NCT04596631

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.

ClinicalTrials.gov public records Last synced Apr 22, 2026, 11:55 AM EDT

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

Study identification

NCT ID
NCT04596631
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novo Nordisk A/S
Industry
Enrollment
132 participants

Conditions and interventions

Interventions

  • Oral semaglutide Drug
  • Placebo (semaglutide) Drug

Drug

Eligibility (public fields only)

Age range
10 Years to 18 Years
Sex
All
Healthy volunteers
Not listed

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
Mar 10, 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 Mar 10, 2026 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04596631 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →