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
- Diseases
- Type 2 diabetes
- 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
Sites (89)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Completed |
| Monash Children's Hospital Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Gosford Hospital Coordinator of this site? Confirm its status | Gosford | Australia | Unknown status |
| Perth Children's Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Women's & Children's Hospital Coordinator of this site? Confirm its status | North Adelaide | Australia | Unknown status |
| Murdoch Children's Research Institute Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Westmead Children's Hospital- The Clinical Research Centre Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Cliniques Universitaires Saint-Luc - Serv. Pédiatrie Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| UZ Brussel Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| CHU - UCL Namur - Site Sainte Elisabeth_Namur_1 Coordinator of this site? Confirm its status | Namur | Belgium | Unknown status |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Completed |
| Krajska zdravotni a.s. Coordinator of this site? Confirm its status | Usti Nad Labem | Czechia | Completed |
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Completed |
| General Hospital of Lamia Coordinator of this site? Confirm its status | Lamia | Greece | Completed |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Completed |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Completed |
| Penteli Childrens General Hospital Coordinator of this site? Confirm its status | Penteli | Greece | Completed |
| University General Hospital of Thessaloniki - AHEPA Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Euromedica General Clinic of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Soroka MC - Pediatric Endocrinology Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Rambam MC - Department of Pediatrics A Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Endolife Specialty Hospitals Coordinator of this site? Confirm its status | Guntur | India | Unknown status |
| Dr P V Rao - Diabetes Research Centre Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Ramdev Rao Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Eternal Heart Care Centre Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| Excel Endocrine Centre Coordinator of this site? Confirm its status | Kolhāpur | India | Unknown status |
| SSKM Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| P D Hinduja National Hospital and Medical Research Centre Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Dehli | India | Unknown status |
| Jothydev's Diabetes & Research Center Coordinator of this site? Confirm its status | Thriruvananthapuram | India | Unknown status |
| Chronic Care Center Coordinator of this site? Confirm its status | Hazmiyeh | Lebanon | Unknown status |
| Hôpital d'Enfants Coordinator of this site? Confirm its status | Rabat | Morocco | Unknown status |
| PHI University Clinic for Children's Diseases-Skopje Coordinator of this site? Confirm its status | Skopje | North Macedonia | Unknown status |
| Consultorio de Endocrinología y Pediatría Coordinator of this site? Confirm its status | Puebla City | Mexico | Unknown status |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Lembah Pantai | Malaysia | Unknown status |
| Hospital Putrajaya Coordinator of this site? Confirm its status | Putrajaya | Malaysia | Unknown status |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Completed |
| Liggins Institute Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
| Ponce Med School Found Inc Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Hospital da Luz, S.A Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Centro Hospitalar de Vila Nova de Gaia Espinho E P E Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Completed |
| Diabet Center S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Completed |
| Spitalul Clinic de Urgenta pentru Copii "M.S.Curie" Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Coordinator of this site? Confirm its status | Constanța | Romania | Completed |
| Spitalul Judetean de Urgenta Targoviste Coordinator of this site? Confirm its status | Targoviste | Romania | Completed |
| Republic Children's Hospital of Ministry of Health of Udmurt Coordinator of this site? Confirm its status | Izhevsk | Russia | Unknown status |
| RMAPE Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| NSMU paediatric clinic Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| GFHI Omsk Region "Regional Children's Clinical Hospital" Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| SPSBHI City Children out-patient clinic #44 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Siberian State Medical University Coordinator of this site? Confirm its status | Tomsk | Russia | Unknown status |
| SAHI Sverdlovsk Reg "Regional Children's Clinical Hospital" Coordinator of this site? Confirm its status | Yekaterinburg | Russia | Unknown status |
| Taipei Mackay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital Linkou-Dept of Pediatrics Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| City Clinical Hospital #9 (Dnipro) - Endocrinology department Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| CNPE "City Clinical Hospital #9 Dnipro City Council" Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Kharkiv Regional Children's Clinical Hospital - Endocrinological department Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Ukrainian scientific and practical center of endocrine surgery of MOH - department of paediatric endocrinology Coordinator of this site? Confirm its status | Kiev | Ukraine | Unknown status |
| "Verum clinic" LLC Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2 Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Texas Tech University HSC Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Children's Healthcare Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Barry J. Reiner, MD, LLC Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Pennington Biomed Res Ctr Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| UAB Ped Endo Children's Hosp Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| UBMD Peds-Div of Endo/Diabetes Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Pediatric Endo UVHS Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Columbus Research Foundation Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Indiana Uni School of Med-Ped Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Nemours Chld Clnc Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Children's Hospital Los Angeles - Endocrinology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Louisville Research Foundation Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale School of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Nemours Children's Health Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| UPMC Child Hosp-Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Monument Health Clinical Rsrch Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Virginia Commonwealth University_Richmond Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Virginia Commonwealth Univ Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Univ Of Texas Hlth Science Cntr Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| NE Clin Res of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of South Florida Diabetes Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.