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NCT04596631CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
132 (actual)
First submitted
16 Oct 2020
Start date
2 Nov 2020
Primary completion date
29 Apr 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT04596631
EU CT number
2023-506923-27-00
EudraCT number
2018-002952-34

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 132
  • From 2 Nov 2020 to the primary completion date, 29 Apr 2025
  • 89 sites in 22 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.

Other illness

  • Diagnosis of type 1 diabetes
  • Maturity onset diabetes of the young (MODY)

Who the study is looking for

  • 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

Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (89)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
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SalzburgAustriaCompleted
Monash Children's Hospital
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ClaytonAustraliaUnknown status
Gosford Hospital
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GosfordAustraliaUnknown status
Perth Children's Hospital
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NedlandsAustraliaUnknown status
Women's & Children's Hospital
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North AdelaideAustraliaUnknown status
Murdoch Children's Research Institute
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ParkvilleAustraliaUnknown status
Westmead Children's Hospital- The Clinical Research Centre
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WestmeadAustraliaUnknown status
Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
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BrusselsBelgiumUnknown status
UZ Brussel
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BrusselsBelgiumUnknown status
CHU - UCL Namur - Site Sainte Elisabeth_Namur_1
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NamurBelgiumUnknown status
Fakultni nemocnice Ostrava
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OstravaCzechiaCompleted
Krajska zdravotni a.s.
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Usti Nad LabemCzechiaCompleted
Birmingham Children's Hospital
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BirminghamUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceCompleted
Henry Dunant Hospital Center
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AthensGreeceCompleted
University General Hospital of Ioannina
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IoanninaGreeceCompleted
General Hospital of Lamia
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LamiaGreeceCompleted
General University Hospital of Larissa
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LarissaGreeceCompleted
Athens Medical Center S.A.
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MaroussiGreeceCompleted
Penteli Childrens General Hospital
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PenteliGreeceCompleted
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceCompleted
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceCompleted
Soroka MC - Pediatric Endocrinology
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BeershebaIsraelUnknown status
Rambam MC - Department of Pediatrics A
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HaifaIsraelUnknown status
Endolife Specialty Hospitals
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GunturIndiaUnknown status
Dr P V Rao - Diabetes Research Centre
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HyderabadIndiaUnknown status
Ramdev Rao Hospital
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HyderabadIndiaUnknown status
Eternal Heart Care Centre
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JaipurIndiaUnknown status
Excel Endocrine Centre
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KolhāpurIndiaUnknown status
SSKM
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KolkataIndiaUnknown status
P D Hinduja National Hospital and Medical Research Centre
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MumbaiIndiaUnknown status
All India Institute of Medical Sciences
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New DehliIndiaUnknown status
Jothydev's Diabetes & Research Center
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ThriruvananthapuramIndiaUnknown status
Chronic Care Center
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HazmiyehLebanonUnknown status
Hôpital d'Enfants
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RabatMoroccoUnknown status
PHI University Clinic for Children's Diseases-Skopje
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SkopjeNorth MacedoniaUnknown status
Consultorio de Endocrinología y Pediatría
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Puebla CityMexicoUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
University Malaya Medical Centre
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Lembah PantaiMalaysiaUnknown status
Hospital Putrajaya
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PutrajayaMalaysiaUnknown status
Jeroen Bosch Ziekenhuis
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's-HertogenboschNetherlandsCompleted
Liggins Institute
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GraftonNew ZealandUnknown status
Ponce Med School Found Inc
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PoncePuerto RicoUnknown status
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalCompleted
Hospital da Luz, S.A
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LisbonPortugalCompleted
Centro Hospitalar de Vila Nova de Gaia Espinho E P E
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Vila Nova de GaiaPortugalCompleted
Diabet Center S.R.L.
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BrasovRomaniaCompleted
Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
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BucharestRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
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ConstanțaRomaniaCompleted
Spitalul Judetean de Urgenta Targoviste
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TargovisteRomaniaCompleted
Republic Children's Hospital of Ministry of Health of Udmurt
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IzhevskRussiaUnknown status
RMAPE
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MoscowRussiaUnknown status
NSMU paediatric clinic
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NovosibirskRussiaUnknown status
GFHI Omsk Region "Regional Children's Clinical Hospital"
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OmskRussiaUnknown status
SPSBHI City Children out-patient clinic #44
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Saint PetersburgRussiaUnknown status
Siberian State Medical University
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TomskRussiaUnknown status
SAHI Sverdlovsk Reg "Regional Children's Clinical Hospital"
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YekaterinburgRussiaUnknown status
Taipei Mackay Memorial Hospital
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
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TaoyuanTaiwanUnknown status
City Clinical Hospital #9 (Dnipro) - Endocrinology department
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DniproUkraineUnknown status
CNPE "City Clinical Hospital #9 Dnipro City Council"
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DniproUkraineUnknown status
Kharkiv Regional Children's Clinical Hospital - Endocrinological department
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KharkivUkraineUnknown status
Ukrainian scientific and practical center of endocrine surgery of MOH - department of paediatric endocrinology
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KievUkraineUnknown status
"Verum clinic" LLC
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KyivUkraineUnknown status
Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
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KyivUkraineUnknown status
Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2
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VinnytsiaUkraineUnknown status
Texas Tech University HSC
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AmarilloUnited StatesUnknown status
Children's Healthcare Atlanta
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AtlantaUnited StatesUnknown status
Barry J. Reiner, MD, LLC
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BaltimoreUnited StatesUnknown status
Pennington Biomed Res Ctr
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Baton RougeUnited StatesUnknown status
UAB Ped Endo Children's Hosp
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BirminghamUnited StatesUnknown status
UBMD Peds-Div of Endo/Diabetes
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BuffaloUnited StatesUnknown status
Pediatric Endo UVHS
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CharlottesvilleUnited StatesUnknown status
Columbus Research Foundation
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ColumbusUnited StatesUnknown status
Indiana Uni School of Med-Ped
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IndianapolisUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Nemours Chld Clnc Jacksonville
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JacksonvilleUnited StatesUnknown status
Children's Hospital Los Angeles - Endocrinology
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Los AngelesUnited StatesUnknown status
University of Louisville Research Foundation
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LouisvilleUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Yale School of Medicine
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New HavenUnited StatesUnknown status
Nemours Children's Health
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PensacolaUnited StatesUnknown status
UPMC Child Hosp-Pittsburgh
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PittsburghUnited StatesUnknown status
Monument Health Clinical Rsrch
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Rapid CityUnited StatesUnknown status
Virginia Commonwealth University_Richmond
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RichmondUnited StatesUnknown status
Virginia Commonwealth Univ
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RichmondUnited StatesUnknown status
Univ Of Texas Hlth Science Cntr
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San AntonioUnited StatesUnknown status
NE Clin Res of San Antonio
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San AntonioUnited StatesUnknown status
University of South Florida Diabetes Center
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.