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A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
Sponsor: Novo Nordisk A/S
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.
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
Key Details
Gender
All
Age Range
10 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2020-11-02
Completion Date
2026-02-03
Last Updated
2026-08-21
Healthy Volunteers
No
Conditions
Interventions
Oral semaglutide
Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
Placebo (semaglutide)
Placebo treatment for 52 weeks.
Locations (97)
UAB Ped Endo Children's Hosp
Birmingham, Alabama, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States
Yale School Of Medicine
New Haven, Connecticut, United States
Nemours Chld Clnc Jacksonville
Jacksonville, Florida, United States
Nemours Children's Health
Pensacola, Florida, United States
University of South Florida Diabetes Center
Tampa, Florida, United States
Children's Healthcare Atlanta
Atlanta, Georgia, United States
Columbus Research Foundation
Columbus, Georgia, United States
Indiana Uni School of Med-Ped
Indianapolis, Indiana, United States
University Of Louisville Research Foundation
Louisville, Kentucky, United States
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, United States
Barry J. Reiner, MD LLC
Baltimore, Maryland, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, United States
Monument Health Clinical Rsrch
Rapid City, South Dakota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Tech University HSC
Amarillo, Texas, United States
Univ Of Texas Hlth Science Cntr
San Antonio, Texas, United States
NE Clin Res of San Antonio
San Antonio, Texas, United States
Pediatric Endo UVHS
Charlottesville, Virginia, United States
Virginia Commonwealth University_Richmond
Richmond, Virginia, United States
Virginia Commonwealth Univ
Richmond, Virginia, United States
Gosford Hospital
Gosford, New South Wales, Australia
Westmead Children's Hospital- The Clinical Research Centre
Westmead, New South Wales, Australia
Women's & Children's Hospital
North Adelaide, South Australia, Australia
Monash Children's Hospital
Clayton, Victoria, Australia
Murdoch Children's Research Institute
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg, Austria
UZ Brussel
Brussels, Belgium
Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
Brussels, Belgium
CHU - UCL Namur - Site Sainte Elisabeth_Namur_1
Namur, Belgium
Fakultní Nemocnice Ostrava
Ostrava-Poruba, Czechia
Masarykova nemocnice v Usti nad Labem, o.z. - Detska klinika
Ústí nad Labem, Czechia
University Hospital of Athens ATTIKON
Athens, Attica, Greece
University Hospital of Athens ATTIKON
Haidari-Athens, Attica, Greece
Henry Dunant Hospital Center,2nd Internal Medicine Clinic
Athens, Greece
U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
Athens, Greece
Athens Paediatric Center
Athens, Greece
Iatriko Athinon (Athens Medical Canter)
Athens, Greece
Henry Dunant Hospital Center,2nd Internal Medicine Clinic
Athens, Greece
University General Hospital of Ioannina, Endocrinology
Ioannina, Greece
General Hospital of Lamia
Lamia, Greece
General Hospital of Lamia
Lamia, Greece
Univ Gen Hospital Larisa
Larissa, Greece
Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
Larissa, Greece
Pentelis Children's Hospital - Pediatric Clinic
Penteli, Athens, Greece
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, Greece
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, India
Excel Endocrine Centre
Kolhāpur, Maharashtra, India
P D Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, India
All India Institute of Medical Sciences
New Dehli, New Delhi, India
Eternal Heart Care Centre
Jaipur, Rajasthan, India
Ramdev Rao Hospital
Hyderabad, Telangana, India
Dr P V Rao - Diabetes Research Centre
Hyderabad, Telangana, India
SSKM
Kolkata, West Bengal, India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, India
Soroka MC - Pediatric Endocrinology
Beersheba, Israel
Rambam MC - Department of Pediatrics A
Haifa, Israel
Chronic Care Center
Hazmiyeh, Lebanon
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Putrajaya
Putrajaya, Malaysia
Consultorio de Endocrinología y Pediatría
Puebla City, Mexico
Hôpital d'Enfants
Rabat, Morocco
Jeroen Bosch Zkh
's-Hertogenbosch, Netherlands
De Kinderkliniek
Almere Stad, Netherlands
Liggins Institute
Grafton, New Zealand
PHI University Clinic for Children's Diseases-Skopje
Skopje, North Macedonia
Hospital da Luz Lisboa, S.A.
Lisbon, Portugal
Unidade De Santa Maria E.P.E. - Hospital de Santa Maria
Lisbon, Portugal
ULS De Gaia/Espinho_H.Santos Silva_Pediatria
Vila Nova de Gaia, Portugal
Ponce Med School Found Inc
Ponce, Puerto Rico
Spitalul Judetean de Urgenta Targoviste
Targoviste, Dâmbovița County, Romania
Diabet Center SRL
Brasov, Romania
Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
Bucharest, Romania
Emergency County Hospital Constanta
Constanța, Romania
Republic Children's Hospital of Ministry of Health of Udmurt
Izhevsk, Russia
RMAPE
Moscow, Russia
NSMU paediatric clinic
Novosibirsk, Russia
GFHI Omsk Region "Regional Children's Clinical Hospital"
Omsk, Russia
SPSBHI City Children out-patient clinic #44
Saint Petersburg, Russia
Siberian State Medical University
Tomsk, Russia
SAHI Sverdlovsk Reg "Regional Children's Clinical Hospital"
Yekaterinburg, Russia
Taipei Mackay Memorial Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
Taoyuan, Taiwan
City Clinical Hospital #9 (Dnipro) - Endocrinology department
Dnipro, Ukraine
CNPE "City Clinical Hospital #9 Dnipro City Council"
Dnipro, Ukraine
Kharkiv Regional Children's Clinical Hospital - Endocrinological department
Kharkiv, Ukraine
Ukrainian scientific and practical center of endocrine surgery of MOH - department of paediatric endocrinology
Kiev, Ukraine
"Verum clinic" LLC
Kyiv, Ukraine
Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
Kyiv, Ukraine
Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2
Vinnytsia, Ukraine
Birmingham Children's Hospital
Birmingham, United Kingdom