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Badanie porównujące nowy lek doustny Semaglutyd z lekiem obojętnym u dzieci i młodzieży z cukrzycą typu 2 (PIONEER TEENS)

30 lipca 2026 zaktualizowane przez: Novo Nordisk A/S

Skuteczność i bezpieczeństwo doustnego semaglutydu w porównaniu z placebo w skojarzeniu z metforminą i/lub insuliną bazową u dzieci i młodzieży z cukrzycą typu 2

W badaniu tym porównano 2 leki na cukrzycę typu 2: semaglutyd (nowy lek) i lek obojętny (placebo). Semaglutyd zostanie przetestowany, aby zobaczyć, jak dobrze działa w porównaniu z lekiem obojętnym. Badanie sprawdzi również, czy semaglutyd jest bezpieczny dla dzieci i młodzieży. Uczestnicy dostaną albo semaglutyd, albo lek obojętny – o tym, który z nich decyduje przypadek. Uczestnicy będą przyjmować codziennie rano 1 tabletkę badanego leku na pusty żołądek. Muszą odczekać 30 minut przed jedzeniem, piciem lub przyjmowaniem innych leków doustnie. Badanie potrwa około 1 roku i 3 miesięcy (66 tygodni). Uczestnicy będą mieli 12 wizyt w klinice i 8 rozmów telefonicznych z lekarzem prowadzącym badanie. Podczas wszystkich 12 wizyt w klinice od uczestników zostaną pobrane próbki krwi. Uczestnikom zadawane będą również pytania.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

132

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Gosford Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Children's Hospital- The Clinical Research Centre
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Women's & Children's Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Children's Hospital
      • Parkville, Victoria, Australia, 3052
        • Murdoch Children's Research Institute
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Perth Children's Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Universitätsklinik für Kinder und Jugendheilkunde Haus E
  • Belgia
      • Brussels, Belgia, 1090
        • UZ Brussel
      • Brussels, Belgia, 1200
        • Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
      • Namur, Belgia, 5000
        • CHU - UCL Namur - Site Sainte Elisabeth_Namur_1
  • Czechy
      • Ostrava-Poruba, Czechy, 708 00
        • Fakultni Nemocnice Ostrava
      • Ústí nad Labem, Czechy, 40011
        • Masarykova nemocnice v Usti nad Labem, o.z. - Detska klinika
  • Grecja
      • Athens, Grecja, GR-11526
        • Henry Dunant Hospital Center,2nd Internal Medicine Clinic
      • Athens, Grecja, 15125
        • Iatriko Athinon (Athens Medical Canter)
      • Athens, Grecja, 12462
        • U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
      • Athens, Grecja, 11526
        • Henry Dunant Hospital Center,2nd Internal Medicine Clinic
      • Athens, Grecja, 15125
        • Athens Paediatric Center
      • Ioannina, Grecja, 45500
        • University General Hospital of Ioannina, Endocrinology
      • Lamia, Grecja, GR35100
        • General Hospital of Lamia
      • Lamia, Grecja, 35100
        • General Hospital of Lamia
      • Larissa, Grecja, GR-41110
        • Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
      • Larissa, Grecja, 41110
        • Univ Gen Hospital Larisa
      • Penteli, Athens, Grecja, 15236
        • Pentelis Children's Hospital - Pediatric Clinic
      • Thessaloniki, Grecja, 54636
        • "AHEPA" University General Hospital of Thessaloniki
      • Thessaloniki, Grecja, 54645
        • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
    • Attica
      • Athens, Attica, Grecja, 12462
        • University Hospital of Athens ATTIKON
      • Haidari-Athens, Attica, Grecja, GR-12462
        • University Hospital of Athens ATTIKON
  • Holandia
      • 's-Hertogenbosch, Holandia, 5223 GZ
        • Jeroen Bosch Zkh
      • Almere Stad, Holandia, 1315 RC
        • De Kinderkliniek
  • Indie
      • Thriruvananthapuram, Indie, 695 032
        • Jothydev's Diabetes & Research Center
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, Indie, 522001
        • Endolife Specialty Hospitals
    • Maharashtra
      • Kolhāpur, Maharashtra, Indie, 416008
        • Excel Endocrine Centre
      • Mumbai, Maharashtra, Indie, 400016
        • P D Hinduja National Hospital and Medical Research Centre
    • New Delhi
      • New Dehli, New Delhi, Indie, 110029
        • All India Institute of Medical Sciences
    • Rajasthan
      • Jaipur, Rajasthan, Indie, 302017
        • Eternal Heart Care Centre
    • Telangana
      • Hyderabad, Telangana, Indie, 500072
        • Ramdev Rao Hospital
      • Hyderabad, Telangana, Indie, 50082
        • Dr P V Rao - Diabetes Research Centre
    • West Bengal
      • Kolkata, West Bengal, Indie, 700020
        • SSKM
  • Izrael
      • Beersheba, Izrael, 84101
        • Soroka MC - Pediatric Endocrinology
      • Haifa, Izrael, 31096
        • Rambam MC - Department of Pediatrics A
  • Liban
      • Hazmiyeh, Liban, 21211
        • Chronic Care Center
  • Macedonia Północna
      • Skopje, Macedonia Północna, 1000
        • PHI University Clinic for Children's Diseases-Skopje
  • Malezja
      • Kuala Lumpur, Malezja, 59100
        • University Malaya Medical Centre
      • Putrajaya, Malezja, 62250
        • Hospital Putrajaya
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malezja, 59100
        • University Malaya Medical Centre
      • Lembah Pantai, Kuala Lumpur, Malezja, 59100
        • University Malaya Medical Centre
  • Maroko
      • Rabat, Maroko, 10000
        • Hôpital d'Enfants
  • Meksyk
      • Puebla City, Meksyk, 72190
        • Consultorio de Endocrinología y Pediatría
  • Nowa Zelandia
      • Grafton, Nowa Zelandia, 1023
        • Liggins Institute
  • Portoryko
      • Ponce, Portoryko, 00716
        • Ponce Med School Found Inc
  • Portugalia
      • Lisbon, Portugalia, 1500-650
        • Hospital da Luz Lisboa, S.A.
      • Lisbon, Portugalia, 1649-035
        • Unidade De Santa Maria E.P.E. - Hospital de Santa Maria
      • Vila Nova de Gaia, Portugalia, 4400-129
        • ULS De Gaia/Espinho_H.Santos Silva_Pediatria
  • Rosja
      • Izhevsk, Rosja, 426009
        • Republic Children's Hospital of Ministry of Health of Udmurt
      • Moscow, Rosja, 125373
        • RMAPE
      • Novosibirsk, Rosja, 630048
        • NSMU paediatric clinic
      • Omsk, Rosja, 644001
        • GFHI Omsk Region "Regional Children's Clinical Hospital"
      • Saint Petersburg, Rosja, 191144
        • SPSBHI City Children out-patient clinic #44
      • Tomsk, Rosja, 634050
        • Siberian State Medical University
      • Yekaterinburg, Rosja, 620149
        • SAHI Sverdlovsk Reg "Regional Children's Clinical Hospital"
  • Rumunia
      • Brasov, Rumunia, 500260
        • Diabet Center SRL
      • Bucharest, Rumunia, 041451
        • Spitalul Clinic de Urgenta pentru Copii "M.S.Curie"
      • Constanța, Rumunia, 900591
        • Emergency County Hospital Constanta
    • Dâmbovița County
      • Targoviste, Dâmbovița County, Rumunia, 130083
        • Spitalul Judetean de Urgenta Targoviste
  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35233
        • UAB Ped Endo Children's Hosp
    • California
      • Los Angeles, California, Stany Zjednoczone, 90027
        • Children's Hospital Los Angeles - Endocrinology
    • Connecticut
      • New Haven, Connecticut, Stany Zjednoczone, 06520
        • Yale School of Medicine
    • Florida
      • Jacksonville, Florida, Stany Zjednoczone, 32207
        • Nemours Chld Clnc Jacksonville
      • Pensacola, Florida, Stany Zjednoczone, 32514
        • Nemours Children's Health
      • Tampa, Florida, Stany Zjednoczone, 33612
        • University of South Florida Diabetes Center
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30329
        • Children's Healthcare Atlanta
      • Columbus, Georgia, Stany Zjednoczone, 31904
        • Columbus Research Foundation
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46202
        • Indiana Uni School of Med-Ped
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40202
        • University Of Louisville Research Foundation
    • Louisiana
      • Baton Rouge, Louisiana, Stany Zjednoczone, 70808-4124
        • Pennington Biomed Res Ctr
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21229
        • Barry J. Reiner, MD LLC
    • Mississippi
      • Jackson, Mississippi, Stany Zjednoczone, 39216
        • University of Mississippi Medical Center
    • New York
      • Buffalo, New York, Stany Zjednoczone, 14203
        • UBMD Peds-Div of Endo/Diabetes
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224
        • UPMC Child Hosp-Pittsburgh
    • South Dakota
      • Rapid City, South Dakota, Stany Zjednoczone, 57701
        • Monument Health Clinical Rsrch
    • Tennessee
      • Nashville, Tennessee, Stany Zjednoczone, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Amarillo, Texas, Stany Zjednoczone, 79106
        • Texas Tech University HSC
      • San Antonio, Texas, Stany Zjednoczone, 78207
        • Univ Of Texas Hlth Science Cntr
      • San Antonio, Texas, Stany Zjednoczone, 78233
        • NE Clin Res of San Antonio
    • Virginia
      • Charlottesville, Virginia, Stany Zjednoczone, 22908
        • Pediatric Endo UVHS
      • Richmond, Virginia, Stany Zjednoczone, 23298
        • Virginia Commonwealth Univ
      • Richmond, Virginia, Stany Zjednoczone, 23298
        • Virginia Commonwealth University_Richmond
  • Tajwan
      • Taipei, Tajwan, 104
        • Taipei Mackay Memorial Hospital
      • Taoyuan, Tajwan, 333
        • Chang Gung Memorial Hospital Linkou-Dept of Pediatrics
  • Ukraina
      • Dnipro, Ukraina, 49023
        • CNPE "City Clinical Hospital #9 Dnipro City Council"
      • Dnipro, Ukraina, 49023
        • City Clinical Hospital #9 (Dnipro) - Endocrinology department
      • Kharkiv, Ukraina, 61093
        • Kharkiv Regional Children's Clinical Hospital - Endocrinological department
      • Kiev, Ukraina, 01021
        • Ukrainian scientific and practical center of endocrine surgery of MOH - department of paediatric endocrinology
      • Kyiv, Ukraina, 03039
        • "Verum clinic" LLC
      • Kyiv, Ukraina, 04114
        • Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology
      • Vinnytsia, Ukraina, 21010
        • Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2
  • Zjednoczone Królestwo
      • Birmingham, Zjednoczone Królestwo, B4 6NH
        • Birmingham Children's Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

10 lat do 18 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Opis

Kryteria przyjęcia:

  • Świadoma zgoda rodzica (rodziców) lub prawnie dopuszczalnego przedstawiciela (LAR) oraz zgoda dziecka uczestnika uzyskana przed jakimikolwiek czynnościami związanymi z badaniem. Czynności związane z badaniem to wszelkie procedury przeprowadzane w ramach badania, w tym czynności mające na celu ustalenie przydatności do badania.
  • Mężczyzna lub kobieta w wieku od 10 do poniżej 18 lat w dniu randomizacji
  • HbA1c 6,5%-11,0% (47-97 mmol/mol) (oba włącznie)
  • Zdiagnozowana cukrzyca typu 2 zgodnie z kryteriami American Diabetes Association i leczona:
  • stabilna dawka metforminy (stabilna dawka metforminy to co najmniej 1000 mg na dobę lub maksymalna dawka tolerowana przez 56 dni lub dłużej przed badaniem przesiewowym) lub
  • stabilna dawka metforminy i stabilna dawka insuliny bazowej (stabilną dawkę insuliny bazowej definiuje się jako leczenie insuliną bazową równą lub większą niż 30 dni przed badaniem przesiewowym, w porównaniu z dawką w badaniu przesiewowym, dopuszcza się modyfikacje dawki ± 25%) lub
  • stabilna dawka insuliny bazowej

Kryteria wyłączenia:

  • Rozpoznanie cukrzycy typu 1
  • Cukrzyca wieku dojrzewania u młodych (MODY)
  • Dodatnie przeciwciała przeciwko białku 2 (IA-2) związanemu z insulinoma lub przeciwciała przeciw dekarboksylazie kwasu glutaminowego (anty-GAD).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Semaglutyd - maks. tolerowana dawka
Uczestnicy będą otrzymywać tabletki semaglutydu raz dziennie jako uzupełnienie leczenia podstawowego metforminą lub insuliną bazową lub jednym i drugim, oprócz diety i ćwiczeń fizycznych.
Lek: Doustny semaglutyd
Doustne leczenie semaglutydem przez 52 tygodnie. Wszystkim uczestnikom dawka zostanie zwiększona do indywidualnej maksymalnej tolerowanej dawki.
Komparator placebo: Placebo (semaglutyd)
Uczestnicy będą otrzymywać semaglutyd w postaci tabletek placebo raz dziennie jako dodatek do leczenia podstawowego metforminą lub insuliną bazową lub jednym i drugim, oprócz diety i ćwiczeń fizycznych.
Lek: Placebo (semaglutyd)
Leczenie placebo przez 52 tygodnie.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline (Week 0) to Week 26 in Glycosylated Haemoglobin (HbA1c)- Percentage Point
Ramy czasowe: Baseline (Week 0), Week 26
This outcome measure reports change from baseline to week 26 in HbA1c measured in terms of percentage point.
Baseline (Week 0), Week 26
Change From Baseline (Week 0) in HbA1c to Week 26- Millimoles Per Mole (mmol/Mol)
Ramy czasowe: Baseline (Week 0), Week 26
This outcome measure reports change from baseline to week 26 in HbA1c in terms of mmol/mol.
Baseline (Week 0), Week 26

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline (Week 0) in Fasting Plasma Glucose (FPG) to Week 26
Ramy czasowe: Baseline (Week 0), Week 26
This outcome measure reports change from baseline in FPG to week 26 measured in terms of milligrams per deciliter (mg/dL).
Baseline (Week 0), Week 26
Change From Baseline (Week 0) in Body Mass Index (BMI) Standard Deviation Score (SDS) to Week 26
Ramy czasowe: Baseline (Week 0), Week 26
This outcome measure reports change from baseline to week 26 in BMI measured in terms of the SDS. BMI SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The BMI SDS formula comes from the LMS method as: Z = ([BMI/M)]^L-1)/ L×S where: L=Skewness (Box-Cox power); M=Median; S= (Coefficient of Variation).
Baseline (Week 0), Week 26
Change From Baseline in HbA1c at Week 52 (Percentage Point)
Ramy czasowe: Baseline (Week 0), Week 52
This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of percentage point.
Baseline (Week 0), Week 52
Change From Baseline in HbA1c at Week 52 (mmol/Mol)
Ramy czasowe: Baseline (Week 0), Week 52
This outcome measure reports change from baseline to week 52 in HbA1c measured in terms of mmol/mol.
Baseline (Week 0), Week 52
Change From Baseline in Fasting Plasma Glucose at Week 52 (mg/dL)
Ramy czasowe: Baseline (Week 0), Week 52
This outcome measure reports change from baseline to week 52 in FPG measured in terms of mg/dL.
Baseline (Week 0), Week 52
Change From Baseline in Body Weight to Week 26 and Week 52 (Kilograms [kg])
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline to week 26 and week 52 in body weight measured in terms of kg.
Baseline (Week 0), Week 26, Week 52
Relative Change From Baseline in Body Weight to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports relative change from baseline to week 26 and week 52 in body weight measured in terms of percent change.
Baseline (Week 0), Week 26, Week 52
Change From Baseline in Waist Circumference to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline to week 26 and week 52 in Waist circumference measured in terms of centimeters (cm).
Baseline (Week 0), Week 26, Week 52
Change From Baseline in Body Mass Index Standard Deviation Score at Week 52
Ramy czasowe: Baseline (Week 0), Week 52

This outcome measure reports change from baseline to week 52 in BMI measured in terms of SDS. BMI SDS was calculated based on the WHO 2007 growth reference for children and adolescents.

The BMI SDS formula comes from the LMS method: Z = ([BMI/M)]^L-1)/ L×S where: L=Skewness (Box-Cox power), M=Median, S= (Coefficient of Variation)
Baseline (Week 0), Week 52
Change From Baseline (Week 0) in BMI Percentile (Age and Gender Adjusted) to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline (Week 0) in BMI percentile on gender and age-specific growth charts change in terms of percentile of BMI to week 26 and week 52. BMI Percentile was calculated using the CDC 2000 Reference Growth Charts and was derived using the standard LMS method. The CDC reference-specific parameters - L (Lambda), M (Median) and S (Coefficient of Variation) were extracted from the CDC reference tables based on each subject's age (in months) and sex. These parameters were used to compute BMI Z-scores, which were subsequently converted to percentiles using the standard normal distribution function.
Baseline (Week 0), Week 26, Week 52
Change From Baseline in Body Mass Index at Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline to week 52 in BMI measured in terms of Kilograms per meter square (kg/m^2).
Baseline (Week 0), Week 26, Week 52
Percent Change From Baseline in Body Mass Index at Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports percent change from baseline to week 26 and week 52 in BMI measured in terms of percent change.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Body Mass Index Percentage of the 95th Percentile to Week 26 and to Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline (week 0) in BMI percentage of the 95th percentile in terms of percentage point to week 26 and week 52. BMI Percentage of the 95th Percentile was calculated using the CDC 2000 Reference Growth Charts and was calculated as the ratio of the subject's observed BMI to the CDC age-and-sex-specific 95th percentile BMI reference value, expressed as a percentage.
Baseline (Week 0), Week 26, Week 52
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline in systolic and diastolic blood pressure at week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Percentage of Participants With HbA1c Less Than (<) 7.0% (53 mmol/Mol) at Week 26 and Week 52 (Yes/No/Missing)
Ramy czasowe: At Week 26 and Week 52
This outcome measure reports percentage of participants with HbA1c <7.0% at week 26 and week 52 in terms of Yes, No, and Missing.
At Week 26 and Week 52
Percentage of Participants With HbA1c Less Than or Equals (≤) 6.5% (48 mmol/Mol) at Week 26 and Week 52 (Yes/No/Missing)
Ramy czasowe: At Week 26 and Week 52
This outcome measure reports percentage of participants with HbA1c <6.5% (48 mmol/mol) at week 26 and week 52 in terms of Yes, No, and Missing.
At Week 26 and Week 52
Number of Events With Initiation of Additional Anti-diabetic Medication
Ramy czasowe: At Week 52
This outcome measure reports number of events with initiation of additional anti-diabetic medication . Anti-diabetic medication was defined as new anti-diabetic medication and/or intensification of anti-diabetic medication initiated at or after randomization and before (planned) end-of-treatment.
At Week 52
Number of Events With Initiation of Rescue Medication
Ramy czasowe: At Week 52
This outcome measure reports number of events with initiation of rescue medication. Rescue medication is defined as new anti-diabetic medication and/or intensification of antidiabetic medication initiated at or after randomization and before last date on trial product. This is a subset of the additional anti-diabetic medication.
At Week 52
Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product for All Participants
Ramy czasowe: From Baseline (Week 0) to Week 57
This outcome measure reports number of TEAEs during exposure to trial product for all participants in each arm were assessed up to approximately 57 weeks. Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. TEAE is defined as an AE with onset in the on-treatment observation period.
From Baseline (Week 0) to Week 57
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes From Randomization to Week 26 for All Participants
Ramy czasowe: From Baseline (Week 0) to Week 26
This outcome measure reports number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes from randomization to week 26. Data reflects the total number of episodes across all participants in each arm. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to the International Society for Paediatric and Adolescent Diabetes (ISPAD) classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose)?
From Baseline (Week 0) to Week 26
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes, Assessed for 57 Weeks
Ramy czasowe: From Baseline (Week 0) to Week 57
This outcome measure represented number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product, assessed up to approximately 57 weeks. Data reflects the total number of episodes across all participants in each Arm. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to ISPAD classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose).
From Baseline (Week 0) to Week 57
Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episode From Randomization to Week 26 (Yes/No)
Ramy czasowe: From Baseline (Week 0) to Week 26
This outcome measures report number of participants with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode from randomization to week 26. AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. TEAE is defined as an AE with onset in the on-treatment observation period. Hypoglycaemic episodes was defined as treatment-emergent, if the onset of the episode occurred in the on-treatment period.
From Baseline (Week 0) to Week 26
Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episode During Exposure to Trial Product, Assessed up to Approximately 57 Weeks (Yes/No)
Ramy czasowe: From Baseline (Week 0) to Week 57
This outcome measure reports number of participants with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode during exposure to trial product, assessed up to approximately 57 weeks. Hypoglycaemic episodes was defined as treatment-emergent, if the onset of the episode occurred in the on-treatment period. Treatment-emergent hypoglycaemic episodes is defined as treatment-emergent, if the onset of the episode occurs in the on-treatment period. Severe hypoglycaemia according to the ISPAD classification included response to the following question as yes or no; Question- was the hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose)?
From Baseline (Week 0) to Week 57
Change From Baseline (Week 0) in Amylase to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in amylase from baseline (week 0) to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Lipase to Week 26 and Week 52, Ratio to Baseline
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in lipase from baseline (week 0) to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Insulin-like Growth Factor 1 (IGF-1) to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in IGF-1 from baseline (week 0) to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Insulin-Like Growth Factor Binding Protein 3 (IGFBP 3) Serum to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in IGFBP 3 serum from baseline to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Calcitonin to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in calcitonin from baseline to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Estradiol (for Girls) to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in estradiol from baseline to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Testosterone (for Boys) to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in testosterone (for boys) from baseline to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Prolactin to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in prolactin from baseline to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Thyroid Stimulating Hormone (TSH/Thyrotropin) to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in TSH/thyrotropin from baseline to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Follicle Stimulating Hormone (FSH) to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in FSH from baseline to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Luteinizing Hormone (LH) to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change in LH from baseline to week 26 and week 52.
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Dehydroepiandrosterone Sulfate (DHEAS) to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52
This outcome measure reports change from baseline to week 26 and week 52 in DHEAS.
Baseline (Week 0), Week 26, Week 52
Anti-semaglutide Antibody Status (Positive/Negative/Missing)
Ramy czasowe: Week 0, week 26, week 52, and week 57
This outcome measure reports anti-semaglutide antibody status as positive, negative, and missing on week 0, week 26, week 52, and week 57.
Week 0, week 26, week 52, and week 57
Anti-semaglutide Antibody Titer
Ramy czasowe: From Week 0 to Week 57
This outcome measure was to report anti-semaglutide antibody titer. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titers at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
From Week 0 to Week 57
Anti-semaglutide Antibodies With in Vitro Neutralising Effect to Semaglutide
Ramy czasowe: From Week 0 to Week 57
This outcome measure as to report anti-semaglutide antibodies with in vitro neutralising effect to semaglutide from week 0 to week 57. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
From Week 0 to Week 57
Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Positive/Negative)
Ramy czasowe: From Week 0 to Week 57
This outcome measure reports anti-semaglutide antibodies cross reacting with endogenous GLP-1 status as positive and negative. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
From Week 0 to Week 57
Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1
Ramy czasowe: From Week 0 to Week 57
This outcome measure reports number of participants with cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1 from week 0 to week 57. The positive anti-semaglutide antibody samples was planned to be further characterised for titer and cross reactivity to native GLP-1 and for in vitro neutralising effect towards semaglutide. The samples which were positive for cross-reactivity against native GLP-1 was planned to be further analysed for in vitro neutralising effect towards native GLP-1. However, the positive titer at any time was zero. Hence, anti-semaglutide antibodies assessment could not be performed in this study. Hence, anti-semaglutide antibodies assessment could not be performed in this study.
From Week 0 to Week 57
Height Velocity at Week 26 and Week 52
Ramy czasowe: At week 26 and week 52
This outcome measure reports height velocity at week 26 and week 52. The height velocity was calculated at week 26 and week 52. Height velocity at week 26 is the difference in height at week 26 and baseline, divided by the actual time elapsed in that period. Height velocity at week 52 is the difference in height at week 26, divided by the actual time elapsed in that period.
At week 26 and week 52
Change From Baseline (Week 0) in Height SDS to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, Week 52

This outcome measure reports change from baseline in height SDS to week 26 and week 52. Height SDS described individual's height compares to the average height of a reference population of the same age and sex, where a score of 0 represents the population mean, negative values indicate shorter-than-average height, and positive values indicate taller-than-average height.

Height SDS was calculated based on the WHO 2007 growth reference for children and adolescents. The Height SDS formula comes from the LMS method: Z = ([Height SDS/M)]^L-1)/ L×S where: L=Skewness (Box-Cox power), M=Median, S= (Coefficient of Variation).
Baseline (Week 0), Week 26, Week 52
Change From Baseline (Week 0) in Bone Age Assessment Through X-ray at Week 52
Ramy czasowe: Baseline (Week 0), Week 52
This outcome measure reports change from baseline (week 0) in bone age at week 52 where the assessment was done using X-ray. An X-ray of the left hand and wrist were performed at randomization and at the end of treatment visit for all participants for evaluation of bone age. The X-rays was analyzed by a central reader for determination of bone age.
Baseline (Week 0), Week 52
Change From Baseline (Week 0) in Number of Participants With Pubertal Assessment (Tanner Staging) (Stage 1-5 Where 5 is Full Sexual Maturity) to Week 52
Ramy czasowe: Baseline (Week 0), Week 52
This outcome measure reports change from baseline (week 0) in number of participants with pubertal assessment which was assessed by the Tanner staging in accordance with the stages I-V (stage 1-5 where 5 is full sexual maturity) to week 52. Tanner stage is an overall stage which is the highest stage for girls: Breast development and Pubic hair development; and for boys: genital development and pubic hair development.
Baseline (Week 0), Week 52
Change From Pre-dose to Post-dose (25 and 40 Minutes) in Lactate at Week 12 and Week 26
Ramy czasowe: Pre-dose: Baseline (Week 0), Post-dose (25 mins and 40 mins): Week 12 and Week 26
This outcome measure reports change from pre-dose to post-dose (25 and 40 minutes) in Lactate at week 12 and week 26.
Pre-dose: Baseline (Week 0), Post-dose (25 mins and 40 mins): Week 12 and Week 26
Change From Baseline (Week 0) in Pulse Rate to Week 26 and Week 52
Ramy czasowe: Baseline (Week 0), Week 26, and Week 52
This outcome measure reports change from baseline (week 0) in pulse rate to week 26 and week 52.
Baseline (Week 0), Week 26, and Week 52
Pharmacokinetic (PK): Apparent Clearance (CL/F)
Ramy czasowe: Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
This pharmacokinetic outcome reports CL/F at Week 26: Pre-dose (0 minute before glucose administration) and post dose at 25 and 40 minutes.
Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
PK: Average Concentration (Cavg)
Ramy czasowe: Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
This pharmacokinetic outcome reports Cavg at Week 26.
Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
PK: Sodium N-[8-(2-hydroxybenzoyl) Amino] Caprylate (SNAC) Plasma Concentrations
Ramy czasowe: Week 12 and Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes
This outcome measure reports SNAC plasma concentration at week 12 and week 26.
Week 12 and Week 26: Pre-dose (0 minute before glucose administration), Post dose- 25 and 40 minutes

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novo Nordisk A/S

Śledczy

  • Dyrektor Studium: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

2 listopada 2020

Zakończenie podstawowe (Rzeczywisty)

29 kwietnia 2025

Ukończenie studiów (Rzeczywisty)

3 lutego 2026

Daty rejestracji na studia

Pierwszy przesłany

16 października 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 października 2020

Pierwszy wysłany (Rzeczywisty)

22 października 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NN9924-4437
  • 2018 (Grant/umowa NIH USA)
  • U1111-1218-1527 (Inny identyfikator: World Health Organization (WHO))
  • 2018-002952-34 (Identyfikator rejestru: European Medicines Agency (EudraCT))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

Zgodnie ze zobowiązaniem Novo Nordisk do ujawniania informacji na stronie novonordisk-trials.com

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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