A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
PIONEER TEENS
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
3 other identifiers
interventional
132
21 countries
91
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Nov 2020
Longer than P75 for phase_3 diabetes-mellitus-type-2
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
November 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2026
CompletedMarch 11, 2026
March 1, 2026
4.5 years
October 16, 2020
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in glycosylated haemoglobin (HbA1c)
Percentage point
Week 0, week 26
Secondary Outcomes (70)
Change from baseline in fasting plasma glucose (FPG)
Week 0, week 26
Change from baseline in body mass index (BMI) standard deviation score (SDS)
Week 0, week 26
Change from baseline in glycosylated haemoglobin (HbA1c)
Week 0, week 52
Change from baseline in FPG
Week 0, week 52
Change from baseline in body weight
Week 0, week 26
- +65 more secondary outcomes
Study Arms (2)
Semaglutide - max. tolerated dose
EXPERIMENTALParticipants will receive semaglutide tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.
Placebo (semaglutide)
PLACEBO COMPARATORParticipants will receive semaglutide placebo tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.
Interventions
Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (97)
UAB Ped Endo Children's Hosp
Birmingham, Alabama, 35233, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, 90027, United States
Yale School Of Medicine
New Haven, Connecticut, 06520, United States
Nemours Chld Clnc Jacksonville
Jacksonville, Florida, 32207, United States
Nemours Children's Health
Pensacola, Florida, 32514, United States
University of South Florida Diabetes Center
Tampa, Florida, 33612, United States
Children's Healthcare Atlanta
Atlanta, Georgia, 30329, United States
Columbus Research Foundation
Columbus, Georgia, 31904, United States
Indiana Uni School of Med-Ped
Indianapolis, Indiana, 46202, United States
University Of Louisville Research Foundation
Louisville, Kentucky, 40202, United States
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, 70808-4124, United States
Barry J. Reiner, MD LLC
Baltimore, Maryland, 21229, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, 14203, United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Monument Health Clinical Rsrch
Rapid City, South Dakota, 57701, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Tech University HSC
Amarillo, Texas, 79106, United States
Univ Of Texas Hlth Science Cntr
San Antonio, Texas, 78207, United States
NE Clin Res of San Antonio
San Antonio, Texas, 78233, United States
Pediatric Endo UVHS
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University_Richmond
Richmond, Virginia, 23298, United States
Virginia Commonwealth Univ
Richmond, Virginia, 23298, United States
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Westmead Children's Hospital- The Clinical Research Centre
Westmead, New South Wales, 2145, Australia
Women's & Children's Hospital
North Adelaide, South Australia, 5006, Australia
Monash Children's Hospital
Clayton, Victoria, 3168, Australia
Murdoch Children's Research Institute
Parkville, Victoria, 3052, Australia
Perth Children's Hospital
Nedlands, Western Australia, 6009, Australia
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg, 5020, Austria
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
Brussels, 1200, Belgium
CHU - UCL Namur - Site Sainte Elisabeth_Namur_1
Namur, 5000, Belgium
Fakultní Nemocnice Ostrava
Ostrava-Poruba, 708 00, Czechia
Masarykova nemocnice v Usti nad Labem, o.z. - Detska klinika
Ústí nad Labem, 40011, Czechia
University Hospital of Athens ATTIKON
Athens, Attica, 12462, Greece
University Hospital of Athens ATTIKON
Haidari-Athens, Attica, GR-12462, Greece
Henry Dunant Hospital Center,2nd Internal Medicine Clinic
Athens, 11526, Greece
U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
Athens, 12462, Greece
Athens Paediatric Center
Athens, 15125, Greece
Iatriko Athinon (Athens Medical Canter)
Athens, 15125, Greece
Henry Dunant Hospital Center,2nd Internal Medicine Clinic
Athens, GR-11526, Greece
University General Hospital of Ioannina, Endocrinology
Ioannina, 45500, Greece
General Hospital of Lamia
Lamia, 35100, Greece
General Hospital of Lamia
Lamia, GR35100, Greece
Univ Gen Hospital Larisa
Larissa, 41110, Greece
Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
Larissa, GR-41110, Greece
Pentelis Children's Hospital - Pediatric Clinic
Penteli, Athens, 15236, Greece
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, 54636, Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, 54645, Greece
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001, India
Excel Endocrine Centre
Kolhāpur, Maharashtra, 416008, India
P D Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016, India
All India Institute of Medical Sciences
New Dehli, New Delhi, 110029, India
Eternal Heart Care Centre
Jaipur, Rajasthan, 302017, India
Ramdev Rao Hospital
Hyderabad, Telangana, 500072, India
Dr P V Rao - Diabetes Research Centre
Hyderabad, Telangana, 50082, India
SSKM
Kolkata, West Bengal, 700020, India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, 695 032, India
Soroka MC - Pediatric Endocrinology
Beersheba, 84101, Israel
Rambam MC - Department of Pediatrics A
Haifa, 31096, Israel
Chronic Care Center
Hazmiyeh, 21211, Lebanon
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Putrajaya
Putrajaya, 62250, Malaysia
Consultorio de Endocrinología y Pediatría
Puebla City, 72190, Mexico
Hôpital d'Enfants
Rabat, 10000, Morocco
Jeroen Bosch Zkh
's-Hertogenbosch, 5223 GZ, Netherlands
De Kinderkliniek
Almere Stad, 1315 RC, Netherlands
Liggins Institute
Grafton, 1023, New Zealand
PHI University Clinic for Children's Diseases-Skopje
Skopje, 1000, North Macedonia
Hospital da Luz Lisboa, S.A.
Lisbon, 1500-650, Portugal
Unidade Local De Saúde De Santa Maria E.P.E.
Lisbon, 1649-035, Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, 4400-129, Portugal
Ponce Med School Found Inc
Ponce, 00716, Puerto Rico
Spitalul Judetean de Urgenta Targoviste
Târgovişte, Dâmbovița County, 130083, Romania
Diabet Center SRL
Brasov, 500260, Romania
Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
Bucharest, 041451, Romania
Emergency County Hospital Constanta
Constanța, 900591, Romania
Republic Children's Hospital of Ministry of Health of Udmurt
Izhevsk, 426009, Russia
RMAPE
Moscow, 125373, Russia
NSMU paediatric clinic
Novosibirsk, 630048, Russia
GFHI Omsk Region "Regional Children's Clinical Hospital"
Omsk, 644001, Russia
SPSBHI City Children out-patient clinic #44
Saint Petersburg, 191144, Russia
Siberian State Medical University
Tomsk, 634050, Russia
SAHI Sverdlovsk Reg "Regional Children's Clinical Hospital"
Yekaterinburg, 620149, Russia
Taipei Mackay Memorial Hospital
Taipei, 104, Taiwan
Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
Taoyuan District, 333, Taiwan
City Clinical Hospital #9 (Dnipro) - Endocrinology department
Dnipro, 49023, Ukraine
CNPE "City Clinical Hospital #9 Dnipro City Council"
Dnipro, 49023, Ukraine
Kharkiv Regional Children's Clinical Hospital - Endocrinological department
Kharkiv, 61093, Ukraine
Ukrainian scientific and practical center of endocrine surgery of MOH - department of paediatric endocrinology
Kiev, 01021, Ukraine
"Verum clinic" LLC
Kyiv, 03039, Ukraine
Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
Kyiv, 04114, Ukraine
Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2
Vinnytsia, 21010, Ukraine
Birmingham Children's Hospital
Birmingham, B4 6NH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
November 2, 2020
Primary Completion
April 29, 2025
Study Completion
February 3, 2026
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com