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Eine Forschungsstudie zum Vergleich eines neuen Medikaments, orales Semaglutid, mit einem Scheinmedikament bei Kindern und Jugendlichen mit Typ-2-Diabetes (PIONEER TEENS)

30. Juli 2026 aktualisiert von: Novo Nordisk A/S

Wirksamkeit und Sicherheit von oralem Semaglutid im Vergleich zu Placebo in Kombination mit Metformin und/oder Basalinsulin bei Kindern und Jugendlichen mit Typ-2-Diabetes

Diese Studie vergleicht 2 Medikamente gegen Typ-2-Diabetes: Semaglutid (neues Medikament) und ein Scheinmedikament (Placebo). Semaglutid wird getestet, um zu sehen, wie gut es im Vergleich zum Scheinmedikament wirkt. Die Studie wird auch testen, ob Semaglutid bei Kindern und Jugendlichen sicher ist. Die Teilnehmer erhalten entweder Semaglutid oder das Scheinmedikament – ​​welches zufällig gewählt wird. Die Teilnehmer nehmen jeden Morgen 1 Tablette des Studienmedikaments auf nüchternen Magen ein. Sie müssen 30 Minuten warten, bevor sie essen, trinken oder andere Medikamente oral einnehmen. Die Studie dauert etwa 1 Jahr und 3 Monate (66 Wochen). Die Teilnehmer haben 12 Klinikbesuche und 8 Telefonate mit dem Studienarzt. Bei allen 12 Klinikbesuchen werden den Teilnehmern Blutproben entnommen. Den Teilnehmern werden auch einige Fragen gestellt.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

132

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

10 Jahre bis 18 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Informierte Zustimmung von Eltern oder gesetzlich zulässigem Vertreter (LAR) und Zustimmung des Kindes vom Probanden, die vor allen versuchsbezogenen Aktivitäten eingeholt wurde. Studienbezogene Aktivitäten sind alle Verfahren, die im Rahmen der Studie durchgeführt werden, einschließlich Aktivitäten zur Feststellung der Eignung für die Studie.
  • Männlich oder weiblich, am Tag der Randomisierung 10 bis unter 18 Jahre alt
  • HbA1c 6,5 %-11,0 % (47-97 mmol/mol) (beide inklusive)
  • Diagnostiziert mit Diabetes mellitus Typ 2 gemäß den Kriterien der American Diabetes Association und behandelt mit:
  • stabile Metformin-Dosis (stabile Metformin-Dosis ist definiert als mindestens 1000 mg täglich oder die maximal tolerierte Dosis für 56 Tage oder länger vor dem Screening) oder
  • stabile Dosis von Metformin und eine stabile Dosis von Basalinsulin (eine stabile Dosis von Basalinsulin ist definiert als eine Basalinsulinbehandlung von mindestens 30 Tagen vor dem Screening im Vergleich zur Dosis beim Screening, Dosisanpassungen von ± 25 % sind zulässig) oder
  • stabile Dosis Basalinsulin

Ausschlusskriterien:

  • Diagnose von Typ-1-Diabetes
  • Altersdiabetes der Jugend (MODY)
  • Positive Antikörper gegen Insulinom-assoziiertes Protein 2 (IA-2) oder Anti-Glutaminsäure-Decarboxylase (Anti-GAD)-Antikörper.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Semaglutid - max. tolerierte Dosis
Die Teilnehmer erhalten einmal täglich Semaglutid-Tabletten zusätzlich zur Hintergrundbehandlung mit Metformin oder Basalinsulin oder beidem, zusätzlich zu Diät und Bewegung.
Arzneimittel: Orales Semaglutid
Orale Behandlung mit Semaglutid für 52 Wochen. Alle Teilnehmer werden auf eine individuell maximal tolerierte Dosis dosiseskaliert.
Placebo-Komparator: Placebo (Semaglutid)
Die Teilnehmer erhalten zusätzlich zu Diät und Bewegung einmal täglich Semaglutid-Placebo-Tabletten zusätzlich zur Hintergrundbehandlung mit Metformin oder Basalinsulin oder beidem.
Arzneimittel: Placebo (Semaglutid)
Placebo-Behandlung für 52 Wochen.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline (Week 0) to Week 26 in Glycosylated Haemoglobin (HbA1c)- Percentage Point
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline (Week 0) in Fasting Plasma Glucose (FPG) to Week 26
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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])
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

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Sponsor

Novo Nordisk A/S

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. November 2020

Primärer Abschluss (Tatsächlich)

29. April 2025

Studienabschluss (Tatsächlich)

3. Februar 2026

Studienanmeldedaten

Zuerst eingereicht

16. Oktober 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Oktober 2020

Zuerst gepostet (Tatsächlich)

22. Oktober 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NN9924-4437
  • 2018 (US NIH Stipendium/Vertrag)
  • U1111-1218-1527 (Andere Kennung: World Health Organization (WHO))
  • 2018-002952-34 (Registrierungskennung: European Medicines Agency (EudraCT))

Plan für individuelle Teilnehmerdaten (IPD)

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JA

Beschreibung des IPD-Plans

Gemäß der Offenlegungsverpflichtung von Novo Nordisk auf novonordisk-trials.com

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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