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

Last updated: May 1, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

Oral semaglutide

Placebo (semaglutide)

Clinical Study ID

NCT04596631
NN9924-4437
2018-002952-34
U1111-1218-1527
  • Ages 10-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent from parent(s) or legally acceptable representative (LAR) and childassent from the subject obtained before any trial-related activities. Trial-relatedactivities are any procedures that are carried out as part of the trial, includingactivities 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 DiabetesAssociation criteria and treated with:

  • stable metformin dose (stable metformin dose is defined as at least 1000 mg daily orthe 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 basalinsulin is defined as basal insulin treatment equal to or more than 30 days prior toscreening, compared to the dose at screening, dose adjustments of ± 25% are allowed)or

  • stable dose of basal insulin

Exclusion

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 aciddecarboxylase (anti-GAD) antibodies.

Study Design

Total Participants: 132
Treatment Group(s): 2
Primary Treatment: Oral semaglutide
Phase: 3
Study Start date:
November 02, 2020
Estimated Completion Date:
February 04, 2026

Connect with a study center

  • Gosford Hospital

    Gosford, New South Wales 2250
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Gosford, New South Wales 2250
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Westmead Children's Hospital- The Clinical Research Centre

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    North Adelaide, South Australia 5006
    Australia

    Site Not Available

  • Women's & Children's Hospital

    North Adelaide, South Australia 5006
    Australia

    Site Not Available

  • Monash Children's Hospital

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Murdoch Children's Research Institute

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Perth Children's' Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Universitätsklinik für Kinder und Jugendheilkunde Haus E

    Salzburg, 5020
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Brussel, 1090
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussel, 1090
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • CHU - UCL Namur - Site Sainte Elisabeth_Namur_1

    Namur, 5000
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Namur, 5000
    Belgium

    Active - Recruiting

  • Fakultní Nemocnice Ostrava

    Ostrava-Poruba, 708 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Ostrava-Poruba, 708 52
    Czechia

    Active - Recruiting

  • Masarykova nemocnice v Usti nad Labem, o.z. - Detska klinika

    Usti nad Labem, 40011
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Usti nad Labem, 40113
    Czechia

    Active - Recruiting

  • University Hospital of Athens ATTIKON

    Athens, Attica 12462
    Greece

    Site Not Available

  • University Hospital of Athens ATTIKON

    Haidari-Athens, Attica GR-12462
    Greece

    Site Not Available

  • Athens Paediatric Center

    Athens, GR-15125
    Greece

    Site Not Available

  • Henry Dunant Hospital Center,2nd Internal Medicine Clinic

    Athens, GR-11526
    Greece

    Site Not Available

  • Iatriko Athinon (Athens Medical Canter)

    Athens, GR-15125
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Athens, GR-15125
    Greece

    Active - Recruiting

  • U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic

    Athens, 12462
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Haidari-Athens, GR-12462
    Greece

    Active - Recruiting

  • U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic

    Haidari-Athens, GR-12462
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Ioannina, 45500
    Greece

    Active - Recruiting

  • University General Hospital of Ioannina, Endocrinology

    Ioannina, 45500
    Greece

    Site Not Available

  • General Hospital of Lamia

    Lamia, GR35100
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Lamia, GR35100
    Greece

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Larissa, GR-41110
    Greece

    Active - Recruiting

  • Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease

    Larissa, GR-41110
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Penteli, Athens, 15236
    Greece

    Site Not Available

  • Pentelis Children's Hospital

    Penteli, Athens, 15236
    Greece

    Site Not Available

  • "AHEPA" University General Hospital of Thessaloniki

    Thessaloniki, 54636
    Greece

    Site Not Available

  • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes

    Thessaloniki, GR-54643
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Thessaloniki, GR-54643
    Greece

    Active - Recruiting

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh 522001
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Guntur, Andhra Pradesh 522001
    India

    Active - Recruiting

  • Excel Endocrine Centre

    Kolhapur, Maharashtra 416008
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolhapur, Maharashtra 416008
    India

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra 4000016
    India

    Active - Recruiting

  • P D Hinduja National Hospital and Medical Research Centre

    Mumbai, Maharashtra 400016
    India

    Site Not Available

  • All India Institute of Medical Sciences

    New Dehli, New Delhi 110029
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    New Dehli, New Delhi 110029
    India

    Active - Recruiting

  • Eternal Heart Care Centre

    Jaipur, Rajasthan 302017
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Jaipur, Rajasthan 302017
    India

    Active - Recruiting

  • Diabetes Research Center, Hyderabad

    Hyderabad, Telangana 500072
    India

    Site Not Available

  • Dr P V Rao - Diabetes Research Centre

    Hyderabad, Telangana 50082
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyderabad, Telangana 500072
    India

    Active - Recruiting

  • Ramdev Rao Hospital

    Hyderabad, Telangana 500072
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • SSKM

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • Jothydev's Diabetes & Research Center

    Thriruvananthapuram, 695 032
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Thriruvananthapuram, 695 032
    India

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Beer Sheva, 84101
    Israel

    Active - Recruiting

  • Soroka Medical Center - Pediatric Endocrinology

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Haifa, 31096
    Israel

    Active - Recruiting

  • Rambam Medical Center Children A Dept.

    Haifa, 31096
    Israel

    Site Not Available

  • Chronic Care Center

    Hazmieh, 21211
    Lebanon

    Site Not Available

  • Novo Nordisk Investigational Site

    Hazmieh, 21211
    Lebanon

    Active - Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur 59100
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • Hospital Putrajaya

    Putrajaya, 62250
    Malaysia

    Site Not Available

  • Novo Nordisk Investigational Site

    Putrajaya, 62250
    Malaysia

    Active - Recruiting

  • Consultorio de Endocrinología y Pediatría

    Puebla, 72190
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Puebla, 72190
    Mexico

    Active - Recruiting

  • Hôpital d'Enfants

    Rabat, 10000
    Morocco

    Site Not Available

  • Novo Nordisk Investigational Site

    Rabat, 10000
    Morocco

    Site Not Available

  • De Kinderkliniek

    Almere, 1315 RC
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Almere, 1315 RC
    Netherlands

    Suspended

  • Jeroen Bosch Ziekenhuis

    Den Bosch, 5223 GZ
    Netherlands

    Site Not Available

  • Novo Nordisk Investigational Site

    Den Bosch, 5223 GZ
    Netherlands

    Active - Recruiting

  • Liggins Institute

    Grafton, 1023
    New Zealand

    Site Not Available

  • Novo Nordisk Investigational Site

    Grafton, 1023
    New Zealand

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Skopje, 1000
    North Macedonia

    Active - Recruiting

  • PHI University Clinic for Children's Diseases-Skopje

    Skopje, 1000
    North Macedonia

    Site Not Available

  • Centro Hospitalar Lisboa Norte

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Hospital Da Luz S.A.

    Lisboa, 1500-650
    Portugal

    Site Not Available

  • Hospital da Luz

    Lisboa, 1500-650
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4400-129
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Vila Nova de Gaia, 4400-129
    Portugal

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Ponce, 00716
    Puerto Rico

    Active - Recruiting

  • Ponce Med School Found Inc

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Novo Nordisk Investigational Site

    Targoviste, Dambovita 130086
    Romania

    Active - Recruiting

  • Spitalul Judetean de Urgenta Targoviste

    Targoviste, Dambovita 130083
    Romania

    Site Not Available

  • Diabet Center SRL

    Brasov, 500260
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Brasov, 500260
    Romania

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Bucharest, 041451
    Romania

    Active - Recruiting

  • Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"

    Bucharest, 041451
    Romania

    Site Not Available

  • Emergency County Hospital Constanta

    Constanta, 900591
    Romania

    Site Not Available

  • Novo Nordisk Investigational Site

    Constanta, 900591
    Romania

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Ekaterinburg, 620149
    Russian Federation

    Site Not Available

  • SAHI Sverdlovsk Reg "Regional Children's Clinical Hospital"

    Ekaterinburg, 620149
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Izhevsk, 426009
    Russian Federation

    Site Not Available

  • Republic Children's Hospital of Ministry of Health of Udmurt

    Izhevsk, 426009
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 125373
    Russian Federation

    Site Not Available

  • RMAPE

    Moscow, 125373
    Russian Federation

    Site Not Available

  • NSMU paediatric clinic

    Novosibirsk, 630048
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Novosibirsk, 630048
    Russian Federation

    Site Not Available

  • GFHI Omsk Region "Regional Children's Clinical Hospital"

    Omsk, 644001
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Omsk, 644001
    Russian Federation

    Completed

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 191144
    Russian Federation

    Site Not Available

  • SPSBHI City Children out-patient clinic #44

    Saint-Petersburg, 191144
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Tomsk, 634050
    Russian Federation

    Completed

  • Siberian State Medical University

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Mackay Memorial Hospital- Taipei

    Taipei, 104
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Taipei, 104
    Taiwan

    Active - Recruiting

  • Department of Pediatrics, Chang Gung Memorial Hospital-LinKo

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Novo Nordisk Investigational Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • CNPE "City Clinical Hospital #9 Dnipro City Council"

    Dnipro, 49023
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Dnipro, 49023
    Ukraine

    Active - Recruiting

  • Kharkiv Regional Children Clincial Hospital_Lubyanka

    Kharkiv, 61093
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Kharkiv, 61000
    Ukraine

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Kiev, 01021
    Ukraine

    Site Not Available

  • Scientific and Practical Center of Endocrine Surgery

    Kiev, 01021
    Ukraine

    Site Not Available

  • "Verum clinic" LLC

    Kyiv, 03039
    Ukraine

    Site Not Available

  • Institute of Endocrinology and Metabolism of AMSU

    Kyiv, 04114
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Kyiv, 03039
    Ukraine

    Site Not Available

  • Novo Nordisk Investigational Site

    Vinnytsia, 21010
    Ukraine

    Site Not Available

  • Vinnytsia Med University based on RegionalEndocrinDispensary

    Vinnytsia, 21010
    Ukraine

    Site Not Available

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, B4 6NH
    United Kingdom

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • UAB Ped Endo Children's Hosp

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Children's Hosp-Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California 90027
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Yale School Of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Nemours Chld Clnc Jacksonville

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Nemours Children's Health

    Pensacola, Florida 32514
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • University of South Florida Diabetes Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Children's Healthcare Atlanta

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Columbus Research Foundation

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Indiana Uni School of Med-Ped

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University Of Louisville Research Foundation

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baton Rouge, Louisiana 70808-4124
    United States

    Active - Recruiting

  • Pennington Biomed Research Center

    Baton Rouge, Louisiana 70808-4124
    United States

    Site Not Available

  • Barry J. Reiner, MD LLC

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baltimore, Maryland 21229
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Jackson, Mississippi 39216
    United States

    Suspended

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York 14203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Monument Health Clinical Rsrch

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • Texas Tech University HSC

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Live Oak, Texas 78233
    United States

    Site Not Available

  • NE Clin Res of San Antonio

    San Antonio, Texas 78233
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78233
    United States

    Active - Recruiting

  • Univ Of Texas Hlth Science Cntr

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Schertz, Texas 78154
    United States

    Site Not Available

  • Pediatric Endo UVHS

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Virginia Commonwealth Univ

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Commonwealth University_Richmond

    Richmond, Virginia 23298
    United States

    Site Not Available

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