| Outcome Measures: |
Primary: Change from baseline in glycosylated haemoglobin (HbA1c), Percentage point, Week 0, week 26 | Secondary: Change from baseline in fasting plasma glucose (FPG), mmol/L, Week 0, week 26|Change from baseline in body mass index (BMI) standard deviation score (SDS), SDS, Week 0, week 26|Change from baseline in glycosylated haemoglobin (HbA1c), Percentage point, Week 0, week 52|Change from baseline in FPG, mmol/L, Week 0, week 52|Change from baseline in body weight, kg, Week 0, week 26|Change from baseline in body weight, kg, Week 0, week 52|Relative change from baseline in body weight, Percentage, Week 0, week 26|Relative change from baseline in body weight, Percentage, Week 0, week 52|Change from baseline in waist circumference, cm, Week 0, week 26|Change from baseline in waist circumference, cm, Week 0, week 52|Change from baseline in BMI SDS, SDS, Week 0, week 52|BMI percentile (age and gender adjusted), Percent, Week 0, week 26|BMI percentile (age and gender adjusted), Percent, Week 0, week 52|Change from baseline in systolic blood pressure, mmHg, Week 0, week 26|Change from baseline in systolic blood pressure, mmHg, Week 0, week 52|Change from baseline in diastolic blood pressure, mmHg, Week 0, week 26|Change from baseline in diastolic blood pressure, mmHg, Week 0, week 52|HbA1c below 7.0% (53 mmol/mol) (yes/no), American Diabetes Association (ADA) target and International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines from 2018, Count of participants, At week 26|HbA1c equal to or below 6.5% (48 mmol/mol) (yes/no), American Association of Clinical Endocrinologists (AACE) target, Count of participants, At week 26|HbA1c below 7.0% (53 mmol/mol) (yes/no), ADA target and ISPAD guidelines from 2018, Count of participants, At week 52|HbA1c equal to or below 6.5% (48 mmol/mol) (yes/no), AACE targetat week 26, Count of participants, At week 52|Time to additional anti-diabetic medication (to support the treatment policy estimand), Days, Week 0 - week 52|Time to rescue medication (to support the hypothetical estimand), Days, Week 0 - week 52|Number of treatment-emergent adverse events (TEAEs) during exposure to trial product, Count of events, Week 0 - week 57|Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes, Count of episodes, From randomisation (week 0) to week 26|Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes during exposure to trial product, Count of episodes, Week 0 - week 57|Treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode, Count of participants, From randomisation (week 0) to week 26|Treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episode during exposure to trial product, Count of participants, Week 0 - week 57|Change from baseline in amylase, U/L, Week 0, week 26|Change from baseline in amylase, U/L, Week 0, week 52|Change from baseline in lipase, U/L, Week 0, week 26|Change from baseline in lipase, U/L, Week 0, week 52|Change from baseline in insulin-like growth factor 1 (IGF-1), ng/mL, Week 0, week 26|Change from baseline in insulin-like growth factor 1 (IGF-1), ng/mL, Week 0, week 52|Change from baseline in insulin-like growth factor binding protein 3 (IGFBP 3), ng/mL, Week 0, week 26|Change from baseline in insulin-like growth factor binding protein 3 (IGFBP 3), ng/mL, Week 0, week 52|Change from baseline in calcitonin, pmol/L, Week 0, week 26|Change from baseline in calcitonin, pmol/L, Week 0, week 52|Change from baseline in estradiol (for girls), pmol/L, Week 0, week 26|Change from baseline in estradiol (for girls), pmol/L, Week 0, week 52|Change from baseline in testosterone (for boys), nmol/L, Week 0, week 26|Change from baseline in testosterone (for boys), nmol/L, Week 0, week 52|Change from baseline in prolactin, mIU/L, Week 0, week 26|Change from baseline in prolactin, mIU/L, Week 0, week 52|Change from baseline in thyroid stimulating hormone (TSH/thyrotropin), mIU/L, Week 0, week 26|Change from baseline in thyroid stimulating hormone (TSH/thyrotropin), mIU/L, Week 0, week 52|Change from baseline in follicle stimulating hormone (FSH), mIU/mL, Week 0, week 26|Change from baseline in follicle stimulating hormone (FSH), mIU/mL, Week 0, week 52|Change from baseline in luteinizing hormone (LH), mIU/mL, Week 0, week 26|Change from baseline in luteinizing hormone (LH), mIU/mL, Week 0, week 52|Change from baseline in dehydroepiandrosterone sulfate (DHEAS), μmol/L, Week 0, week 26|Change from baseline in dehydroepiandrosterone sulfate (DHEAS), μmol/L, Week 0, week 52|Anti-semaglutide antibody status, Count of participants, Week 0 - week 57|Anti-semaglutide antibody titer, Count of participants, Up to 57 weeks|Anti-semaglutide antibodies with in vitro neutralising effect to semaglutide, Count of participants, Week 0 to week 57|Anti-semaglutide antibodies cross reacting with endogenous GLP-1, Count of participants, Week 0 to week 57|Cross reacting antibodies with in vitro neutralising effect to endogenous GLP-1, Count of participants, Week 0 to week 57|Height velocity, cm/year, At week 26|Height velocity, cm/year, At week 52|Change from baseline in height SDS, SDS, Week 0, week 26|Change from baseline in bone age assessment, X-ray, Years, Week 0, week 52|Change from baseline in pubertal assessment (Tanner staging), Stage 1-5 where 5 is full sexual maturity, Week 0, week 26|Change from baseline in pubertal assessment (Tanner staging), Stage 1-5 where 5 is full sexual maturity, Week 0, week 52|Change from baseline in pulse rate, Beats/minute, Week 0, week 26|Change from baseline in pulse rate, Beats/minute, Week 0, week 52|Change from pre-dose to post-dose (25 and 40 min) in lactate, mmol/L, At week 12|Change from pre-dose to post-dose (25 and 40 min) in lactate, mmol/L, At week 26|Apparent clearance (CL/F), L/h, Week 0 - week 52|Average concentration (Cavg), nmol/L, Week 0 - week 52|SNAC plasma concentrations, ng/mL, Week 0 - week 52
|
| Locations: |
Children's Hospital Los Angeles - Endocrinology, Los Angeles, California, 90027, United States|Nemours Chld Clnc Jacksonville, Jacksonville, Florida, 32207, United States|Nemours Children's Health, Pensacola, Florida, 32514, United States|University of South Florida Diabetes Center, Tampa, Florida, 33612, United States|Children's Healthcare Atlanta, Atlanta, Georgia, 30329, United States|Columbus Research Foundation, Columbus, Georgia, 31904, United States|Indiana Uni School of Med-Ped, Indianapolis, Indiana, 46202, United States|University Of Louisville Research Foundation, Louisville, Kentucky, 40202, United States|Barry J. Reiner, MD LLC, Baltimore, Maryland, 21229, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|UBMD Peds-Div of Endo/Diabetes, Buffalo, New York, 14203, United States|UPMC Child Hosp-Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Texas Tech University HSC, Amarillo, Texas, 79106, United States|Univ Of Texas Hlth Science Cntr, San Antonio, Texas, 78207, United States|NE Clin Res of San Antonio, San Antonio, Texas, 78233, United States|Virginia Commonwealth University_Richmond, Richmond, Virginia, 23298, United States|Virginia Commonwealth Univ, Richmond, Virginia, 23298, United States|Westmead Children's Hospital- The Clinical Research Centre, Westmead, New South Wales, 2145, Australia|Monash Children's Hospital, Clayton, Victoria, 3168, Australia|Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia|Perth Children's' Hospital, Nedlands, Western Australia, 6009, Australia|Universitätsklinik für Kinder und Jugendheilkunde Haus E, Salzburg, 5020, Austria|Fakultní Nemocnice Ostrava, Ostrava-Poruba, 708 00, Czechia|University Hospital of Athens ATTIKON, Athens, Attica, 12462, Greece|University Hospital of Athens ATTIKON, Haidari-Athens, Attica, GR-12462, Greece|U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic, Athens, 12462, Greece|Henry Dunant Hospital Center,2nd Internal Medicine Clinic, Athens, GR-11526, Greece|University General Hospital of Ioannina, Endocrinology, Ioannina, 45500, Greece|General Hospital of Lamia, Lamia, GR35100, Greece|Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease, Larissa, GR-41110, Greece|"AHEPA" University General Hospital of Thessaloniki, Thessaloniki, 54636, Greece|Endolife Specialty Hospitals, Guntur, Andhra Pradesh, 522001, India|Excel Endocrine Centre, Kolhapur, Maharashtra, 416008, India|P D Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, 4000016, India|P D Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, 400016, India|All India Institute of Medical Sciences, New Dehli, New Delhi, 110029, India|Eternal Heart Care Centre, Jaipur, Rajasthan, 302017, India|Ramdev Rao Hospital, Hyderabad, Telangana, 500072, India|Dr P V Rao - Diabetes Research Centre, Hyderabad, Telangana, 50082, India|SSKM, Kolkata, West Bengal, 700020, India|Jothydev's Diabetes & Research Center, Thriruvananthapuram, 695 032, India|Soroka Medical Center - Pediatric Endocrinology, Beer Sheva, 84101, Israel|Rambam Medical Center Children A Dept., Haifa, 31096, Israel|Chronic Care Center, Hazmieh, 21211, Lebanon|University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia|University Malaya Medical Centre, Kuala Lumpur, 59100, Malaysia|Hospital Putrajaya, Putrajaya, 62250, Malaysia|Consultorio de Endocrinología y Pediatría, Puebla, 72190, Mexico|Hôpital d'Enfants, Rabat, 10000, Morocco|De Kinderkliniek, Almere, 1315 RC, Netherlands|Jeroen Bosch Ziekenhuis, Den Bosch, 5223 GZ, Netherlands|Liggins Institute, Grafton, 1023, New Zealand|PHI University Clinic for Children's Diseases-Skopje, Skopje, 1000, North Macedonia|Hospital Da Luz S.A., Lisboa, 1500-650, Portugal|Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, 4400-129, Portugal|Ponce Med School Found Inc, Ponce, 00716, Puerto Rico|Diabet Center SRL, Brasov, 500260, Romania|Spitalul Clinic de Urgenta pentru Copii "M.S.Curie", Bucharest, 041451, Romania|Emergency County Hospital Constanta, Constanta, 900591, Romania|GFHI Omsk Region "Regional Children's Clinical Hospital", Omsk, 644001, Russian Federation|Siberian State Medical University, Tomsk, 634050, Russian Federation|Mackay Memorial Hospital- Taipei, Taipei, 104, Taiwan|Department of Pediatrics, Chang Gung Memorial Hospital-LinKo, Taoyuan, 333, Taiwan|CNPE "City Clinical Hospital #9 Dnipro City Council", Dnipro, 49023, Ukraine|Kharkiv Regional Children Clincial Hospital_Lubyanka, Kharkiv, 61093, Ukraine|"Verum clinic" LLC, Kyiv, 03039, Ukraine|Birmingham Children's Hospital, Birmingham, B4 6NH, United Kingdom
|
