Could a daily pill help teens control type 2 diabetes?
NCT ID NCT04596631
First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study tested whether a daily pill called oral semaglutide helps children and teenagers (ages 10 to under 18) with type 2 diabetes control their blood sugar better than a placebo. All participants also took standard diabetes medicines like metformin or insulin. The trial lasted about 66 weeks and involved 132 participants. The main goal was to see if semaglutide lowered HbA1c (a measure of blood sugar control) more than the placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral semaglutide
- What this could lead to
- If it works, this could provide a new daily pill option to help children and teenagers better manage their type 2 diabetes.
- What could go wrong
- This is a relatively small trial in a specific age group, and the drug may not work better than placebo or could cause side effects. Long-term benefits and risks are still unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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132 people
The number who actually took part.
- Started
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Nov 2020
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
10 to 18 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Informed consent from parent(s) or legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * Male or female, aged 10 to below 18 years at the day of randomisation * HbA1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive) * Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with: * stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening) or * stable metformin dose and a stable dose of basal insulin (stable dose of basal insulin is defined as basal insulin treatment equal to or more than 30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed) or * stable dose of basal insulin Exclusion Criteria: * Diagnosis of type 1 diabetes * Maturity onset diabetes of the young (MODY) * Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, 54636, Greece
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"Verum clinic" LLC
Kyiv, 03039, Ukraine
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All India Institute of Medical Sciences
New Dehli, New Delhi, 110029, India
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Athens Paediatric Center
Athens, 15125, Greece
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Barry J. Reiner, MD LLC
Baltimore, Maryland, 21229, United States
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Birmingham Children's Hospital
Birmingham, B4 6NH, United Kingdom
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CHU - UCL Namur - Site Sainte Elisabeth_Namur_1
Namur, 5000, Belgium
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CNPE "City Clinical Hospital #9 Dnipro City Council"
Dnipro, 49023, Ukraine
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Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
Taoyuan, 333, Taiwan
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Children's Healthcare Atlanta
Atlanta, Georgia, 30329, United States
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Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, 90027, United States
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Chronic Care Center
Hazmiyeh, 21211, Lebanon
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City Clinical Hospital #9 (Dnipro) - Endocrinology department
Dnipro, 49023, Ukraine
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Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
Brussels, 1200, Belgium
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Columbus Research Foundation
Columbus, Georgia, 31904, United States
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Consultorio de Endocrinología y Pediatría
Puebla City, 72190, Mexico
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De Kinderkliniek
Almere Stad, 1315 RC, Netherlands
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Diabet Center SRL
Brasov, 500260, Romania
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Dr P V Rao - Diabetes Research Centre
Hyderabad, Telangana, 50082, India
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EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, 54645, Greece
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Emergency County Hospital Constanta
Constanța, 900591, Romania
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Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001, India
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Eternal Heart Care Centre
Jaipur, Rajasthan, 302017, India
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Excel Endocrine Centre
Kolhāpur, Maharashtra, 416008, India
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Fakultní Nemocnice Ostrava
Ostrava-Poruba, 708 00, Czechia
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GFHI Omsk Region "Regional Children's Clinical Hospital"
Omsk, 644001, Russia
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General Hospital of Lamia
Lamia, 35100, Greece
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General Hospital of Lamia
Lamia, GR35100, Greece
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Gosford Hospital
Gosford, New South Wales, 2250, Australia
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Henry Dunant Hospital Center,2nd Internal Medicine Clinic
Athens, 11526, Greece
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Henry Dunant Hospital Center,2nd Internal Medicine Clinic
Athens, GR-11526, Greece
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Hospital Putrajaya
Putrajaya, 62250, Malaysia
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Hospital da Luz Lisboa, S.A.
Lisbon, 1500-650, Portugal
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Hôpital d'Enfants
Rabat, 10000, Morocco
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Iatriko Athinon (Athens Medical Canter)
Athens, 15125, Greece
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Indiana Uni School of Med-Ped
Indianapolis, Indiana, 46202, United States
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Jeroen Bosch Zkh
's-Hertogenbosch, 5223 GZ, Netherlands
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Jothydev's Diabetes & Research Center
Thriruvananthapuram, 695 032, India
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Kharkiv Regional Children's Clinical Hospital - Endocrinological department
Kharkiv, 61093, Ukraine
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Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
Kyiv, 04114, Ukraine
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Liggins Institute
Grafton, 1023, New Zealand
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Masarykova nemocnice v Usti nad Labem, o.z. - Detska klinika
Ústí nad Labem, 40011, Czechia
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Monash Children's Hospital
Clayton, Victoria, 3168, Australia
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Monument Health Clinical Rsrch
Rapid City, South Dakota, 57701, United States
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Murdoch Children's Research Institute
Parkville, Victoria, 3052, Australia
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NE Clin Res of San Antonio
San Antonio, Texas, 78233, United States
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NSMU paediatric clinic
Novosibirsk, 630048, Russia
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Nemours Children's Health
Pensacola, Florida, 32514, United States
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Nemours Chld Clnc Jacksonville
Jacksonville, Florida, 32207, United States
-
P D Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016, India
-
PHI University Clinic for Children's Diseases-Skopje
Skopje, 1000, North Macedonia
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Pediatric Endo UVHS
Charlottesville, Virginia, 22908, United States
-
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, 70808-4124, United States
-
Pentelis Children's Hospital - Pediatric Clinic
Penteli, Athens, 15236, Greece
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Perth Children's Hospital
Nedlands, Western Australia, 6009, Australia
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Ponce Med School Found Inc
Ponce, 00716, Puerto Rico
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RMAPE
Moscow, 125373, Russia
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Rambam MC - Department of Pediatrics A
Haifa, 31096, Israel
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Ramdev Rao Hospital
Hyderabad, Telangana, 500072, India
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Republic Children's Hospital of Ministry of Health of Udmurt
Izhevsk, 426009, Russia
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SAHI Sverdlovsk Reg "Regional Children's Clinical Hospital"
Yekaterinburg, 620149, Russia
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SPSBHI City Children out-patient clinic #44
Saint Petersburg, 191144, Russia
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SSKM
Kolkata, West Bengal, 700020, India
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Siberian State Medical University
Tomsk, 634050, Russia
-
Soroka MC - Pediatric Endocrinology
Beersheba, 84101, Israel
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Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
Bucharest, 041451, Romania
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Spitalul Judetean de Urgenta Targoviste
Targoviste, Dâmbovița County, 130083, Romania
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Taipei Mackay Memorial Hospital
Taipei, 104, Taiwan
-
Texas Tech University HSC
Amarillo, Texas, 79106, United States
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U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
Athens, 12462, Greece
-
UAB Ped Endo Children's Hosp
Birmingham, Alabama, 35233, United States
-
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, 14203, United States
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ULS De Gaia/Espinho_H.Santos Silva_Pediatria
Vila Nova de Gaia, 4400-129, Portugal
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UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
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UZ Brussel
Brussels, 1090, Belgium
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Ukrainian scientific and practical center of endocrine surgery of MOH - department of paediatric endocrinology
Kiev, 01021, Ukraine
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Unidade De Santa Maria E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
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Univ Gen Hospital Larisa
Larissa, 41110, Greece
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Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
Larissa, GR-41110, Greece
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Univ Of Texas Hlth Science Cntr
San Antonio, Texas, 78207, United States
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University General Hospital of Ioannina, Endocrinology
Ioannina, 45500, Greece
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University Hospital of Athens ATTIKON
Athens, Attica, 12462, Greece
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University Hospital of Athens ATTIKON
Haidari-Athens, Attica, GR-12462, Greece
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University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
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University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
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University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
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University Of Louisville Research Foundation
Louisville, Kentucky, 40202, United States
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University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
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University of South Florida Diabetes Center
Tampa, Florida, 33612, United States
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Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg, 5020, Austria
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2
Vinnytsia, 21010, Ukraine
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Virginia Commonwealth Univ
Richmond, Virginia, 23298, United States
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Virginia Commonwealth University_Richmond
Richmond, Virginia, 23298, United States
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Westmead Children's Hospital- The Clinical Research Centre
Westmead, New South Wales, 2145, Australia
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Women's & Children's Hospital
North Adelaide, South Australia, 5006, Australia
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Yale School Of Medicine
New Haven, Connecticut, 06520, United States
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