Clinical trial NCT05330325: A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
Official title: A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: SGA, Turner Syndrome, Noonan Syndrome, ISS
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-04-15
Enrollment: 399
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.


Eligibility criteria: Inclusion criteria:

1. Informed consent of parent or legally acceptable representative of participant and child assent, as age appropriate must be obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues.

   Applicable to children with SGA:
3. Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
4. Prepubertal children:

   1. Boys:

      * Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
      * Testis volume below 4 mL
   2. Girls:

      * Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
      * Tanner stage 1 for breast development: No palpable glandular breast tissue)
5. Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
6. Impaired height velocity defined as annualized height velocity below the 50th percentile for chronological age and sex according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
7. Body Mass Index below the 95th percentile according to Centers for Disease Control and Prevention, Body Mass Index-for-age growth charts.

   Applicable to girls with TS:
8. Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis.\*
9. Prepubertal girls:

   * Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
   * Tanner stage 1 for breast development: No palpable glandular breast tissue)
10. Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
11. Historical height measured 6-18 months prior to screening.
12. Thyroid hormone replacement therapy should be adequate and stable for at least 90 days prior to randomization, if applicable.

    Applicable to children with NS:
13. Clinical diagnosis of NS according to van der Burgt score list
14. Prepubertal children:

    1. Boys:

       * Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
       * Testis volume below 4 mL
    2. Girls:

       * Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
       * Tanner stage 1 for breast development: No palpable glandular breast tissue)
15. Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
16. Historical height measured 6-18 months prior to screening.
17. Thyroid hormone replacement therapy should be adequate and stable for at least 90 days prior to randomization, if applicable.

    Applicable to children with ISS:
18. Prepubertal children:

    1. Boys:

       * Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
       * Testis volume below 4 mL
    2. Girls:

       * Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
       * Tanner stage 1 for breast development: No palpable glandular breast tissue)
19. Bone age:

    1. Boys:

       * Bone age below or equal to 12 years.
       * Bone age not delayed or advanced more than 2 years compared to chronological age.
    2. Girls:

       * Bone age below or equal to 11 years.
       * Bone age not delayed or advanced more than 2 years compared to chronological age.
20. Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
21. Historical height measured 6-18 months prior to screening.
22. One normal GH secretion (GH peak above 7 ng/mL) during GH stimulation test performed within 18 months prior to screening or if such a test is not available for children with ISS, a test should be performed as part of the screening assessments and the result must be available prior to randomization.

    * If a 30-cell count is not available for patients with TS, a test should be done, and results must be available prior to randomization.

Exclusion criteria:

1. Known or suspected hypersensitivity to study intervention(s) or related products.
2. Previous randomization into same sub-study in this study.
3. Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical study at the time of randomization.
4. Children with suspected or confirmed growth hormone deficiency according to local practice.
5. laboratory of

   1. fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or
   2. HbA1c above or equal to 6.5%.
6. Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
7. Children requiring inhaled glucocorticoid therapy at a dose greater than 400 µg/day of inhaled budesonide or equivalent (i.e., 250 µg/day for fluticasone propionate) for longer than 4 consecutive weeks within the last 12 months prior to screening.
8. Concomitant administration of other treatments that may have an effect on growth, e.g., but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD).
9. Diagnosis of attention deficit hyperactivity disorder (ADHD).
10. History or known presence of any malignancy, intracranial tumour, or intracranial cyst.
11. History or known presence of active Hepatitis B or Hepatitis C (exceptions to this exclusion criterion is the presence of antibodies due to vaccination against Hepatitis B).
12. Any disorder, which in the investigator's opinion, might jeopardize participant's safety or compliance with the protocol.
13. The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to study conduct, as judged by the investigator.
14. Current treatment with sex hormones or aromatase inhibitors.
15. Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements, such as, but not limited to:

    1. Known family history of skeletal dysplasia.
    2. Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
    3. Any other disorder/condition that can cause short stature such as, but not limited to, psychosocial deprivation, nutritional disorders, chronic systemic illness and chronic renal disease.

Applicable to children with SGA:

1. TS (including mosaicism).
2. NS.
3. Hormonal deficiencies.
4. Children who are small due to malnutrition defined as -2 standard deviations according to standards. 0¬-5 years: weight for height on World Health Organization Multicentre Growth Reference Study 2006. Above 5 years: World Health Organization 2007 Body Mass Index.
5. Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal SHOX gene analysis or absence of GH receptors.

Applicable to children with TS:

1. NS.
2. Mosaicism below 10%.
3. TS with Y-chromosome mosaicism where gonadectomy has not been performed.
4. NYHA class II or above or requiring medication for any heart condition.
5. Coeliac disease where participant is not stable on gluten free diet for the previous 12 months prior to screening.

Applicable to children with NS:

1. TS (including mosaicism).
2. Noonan-related disorders: Noonan syndrome with multiple lentigines (formerly called 'LEOPARD' syndrome), Noonan syndrome with loose anagen hair, cardiofaciocutaneous syndrome (CFC), Costello syndrome, neurofibromatosis type 1 (NF1) and Legius syndrome. Molecular genetic panel testing results must be available prior to randomisation to exclude these.
3. Coeliac disease where participant is not stable on gluten free diet for the previous 12 months prior to screening.

Applicable to children with ISS:

1. TS (including mosaicism).
2. NS.
3. Hormonal deficiencies.
4. Born small for gestational age (defined as birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
5. Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal SHOX gene analysis or absence of GH receptors.

Primary outcomes:
measure: Height velocity reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS)
timeFrame: From baseline (week 0) to visit 7 (week 52)
Secondary outcomes:
measure: Change in Height standard deviation scores (SDS) reported separately for SGA, TS, NS and ISS
timeFrame: From baseline (week 0) to visit 7 (week 52)
measure: Change in Height Velocity SDS reported separately for SGA, TS, NS and ISS
timeFrame: From baseline (week 0) to visit 7 (week 52)
measure: Change in bone age reported separately for SGA, TS and NS
timeFrame: From baseline (week 0) to visit 7 (week 52)
measure: Change in bone age for ISS
timeFrame: From screening (visit 1) to visit 7 (week 52)
measure: Change in insulin-like growth factor 1 (IGF-1) SDS reported separately for SGA, TS, NA and ISS
timeFrame: From baseline (week 0) to visit 7 (week 52).
measure: Change in insulin-like growth factor binding protein-3 (IGFBP-3) SDS reported separately for SGA, TS, NA and ISS
timeFrame: From baseline (week 0) to visit 7 (week 52).
measure: Change in fasting plasma glucose reported separately for SGA, TS, NS and ISS
timeFrame: From screening (visit 1) to visit 7 (week 52)
measure: Change in homeostatic model assessment-B (HOMA-B) reported separately for SGA, TS, NS and ISS
timeFrame: From screening (visit 1) to visit 7 (week 52)
measure: Change in homeostatic model assessment of insulin resistance (HOMAIR) reported separately for SGA, TS, NS and ISS
timeFrame: From screening (visit 1) to visit 7 (week 52)
measure: Change in glycated haemoglobin (HbA1c) reported separately for SGA, TS, NS and ISS
timeFrame: From screening (visit 1) to visit 7 (week 52)
measure: Weekly average somapacitan concentration (Cavg) based on population PK analysis
timeFrame: From visit 3 (week 4) to visit 7 (week 52)
measure: Change in fasting plasma glucose reported separately for SGA, TS, NS and ISS
timeFrame: From screening (visit 1) to visit 15 (week 156)
measure: Change in homeostatic model assessment-B (HOMA-B) reported separately for SGA, TS, NS and ISS
timeFrame: From screening (visit 1) to visit 15 (week 156)
measure: Change in homeostatic model assessment of insulin resistance (HOMA-IR) reported separately for SGA, TS, NS and ISS
timeFrame: From screening (visit 1) to visit 15 (week 156)
measure: Change in glycated haemoglobin (HbA1c) reported separately for SGA, TS, NS and ISS
timeFrame: From screening (visit 1) to visit 15 (week 156)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles - Endocrinology
state: California
city: Sacramento
country: United States
facility: Sutter Valley Med Fdt Ped Endo
state: California
city: San Diego
country: United States
facility: Rady Childrens Hosp San Diego
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Greenwood Village
country: United States
facility: Ped Endo Assoc PC-G.V
state: Colorado
city: Wilmington
country: United States
facility: Nemours/AI duPont Hosp-Chld
state: Delaware
city: Washington
country: United States
facility: Childrens National Medical Ctr
state: District of Columbia
city: Jacksonville
country: United States
facility: Nemours Chld Clnc Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Boise
country: United States
facility: St. Luke's Children's Endo
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mt Clin Res, LLC
state: Idaho
city: Indianapolis
country: United States
facility: Riley Hosp for Child-Indiana U
state: Indiana
city: Iowa City
country: United States
facility: University OF Iowa
state: Iowa
city: Minneapolis
country: United States
facility: Univ of Minnesota M.C.H.
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Minnesota
state: Minnesota
city: Jackson
country: United States
facility: Univ of Mississippi Med Ctr
state: Mississippi
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
city: Morristown
country: United States
facility: Goryeb Children's Hospital
state: New Jersey
city: Garden City
country: United States
facility: NYU Langone Hospital-LI
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital-LI
state: New York
city: Raleigh
country: United States
facility: WakeMed Childn Endo-Dbt_Raleig
state: North Carolina
city: Cincinnati
country: United States
facility: CCHMC_Cinc
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Child Hosp-Pittsburgh
state: Pennsylvania
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Tacoma
country: United States
facility: MultiCare Inst for Res & Innov
state: Washington
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK)
state: Upper Austria
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
city: Edegem
country: Belgium
facility: UZA - UZ Antwerpen - Kinderziekenhuis
city: Leuven
country: Belgium
facility: UZ Leuven - Kindergeneeskunde
city: Curitiba
country: Brazil
facility: Centro de Diabetes Curitiba
state: Parana
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica Ltda
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Santa Casa Sao Paulo
state: SP
city: São Paulo
country: Brazil
facility: Hosp. Das Clínicas Da Fac. de Med.Da Universidade de Sp
state: SP
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. Georgi Stranski" Pleven
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sveti Georgi" Clinica of Pediatric
city: Sofia
country: Bulgaria
facility: "SHATPD - Prof. Ivan Mitev" EAD
city: Varna
country: Bulgaria
facility: MHAT "Sveta Marina"
city: Ottawa
country: Canada
facility: Children's Hosp-East Ontario
state: Ontario
city: Beijing
country: China
facility: Beijing Children's Hospital，Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Sanya
country: China
facility: Sanya Central Hospital (Hainan Third People's Hospital)-Pediatric
state: Hainan
city: Zhengzhou
country: China
facility: Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
state: Henan
city: Wuhan
country: China
facility: Wuhan Children Hospital-Endocrine Genetics and Metabolism
state: Hubei
city: Wuhan
country: China
facility: Wuhan Children Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST-Pediatric
state: Hubei
city: Changsha
country: China
facility: Hunan Children's Hospital-Child health centre
state: Hunan
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University-Pediatric
state: Jilin
city: Jinan
country: China
facility: Shandong Provincial Hospital-Pediatric
state: Shandong
city: Shanghai
country: China
facility: Shanghai Children's Medical Center-Endocrine Genetics and Metabolism
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Women's and Children's central hospital
state: Sichuan
city: Zagreb
country: Croatia
facility: KBC "Sestre Milosrdnice"
city: Helsinki
country: Finland
facility: HUS Uusi lastensairaala
city: ANGERS cedex 09
country: France
facility: Centre Hospitalier Régional Universitaire d' Angers
city: Angers
country: France
facility: Centre Hospitalier Universitaire D'Angers-2
city: Bordeaux Cedex
country: France
facility: CHU Pellegrin
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
city: Le Kremlin-Bicetre
country: France
facility: Ap-Hp-Hopital de Bicetre-1
city: Le Kremlin-bicetre
country: France
facility: Hopital de Bicetre_Le Kremlin-Bicetre
city: MARSEILLE Cédex 05
country: France
facility: Hopital de La Timone
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2
city: Paris
country: France
facility: Ap-Hp-Hopital Necker-2
city: Paris
country: France
facility: Hôpital Necker
city: Toulouse Cedex 9
country: France
facility: Hopital Des Enfants-1
city: Toulouse
country: France
facility: CHU de Toulouse
city: Frankfurt am Main
country: Germany
facility: Endokrinologikum Frankfurt
city: Homburg
country: Germany
facility: Klinik für Allgemeine Pädiatrie und Neonatologie
city: Athens
country: Greece
facility: U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic
city: Goudi/Athens
country: Greece
facility: Childrens' Hospital of Athens "Agia Sofia"
city: Goudi/Athens
country: Greece
facility: P & A Kyriakou Childrens' Hospital
city: Patra
country: Greece
facility: General University of Patra - Paediatric Department
city: Thessaloniki
country: Greece
facility: 'Ippokrateio' General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: "AHEPA" University General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
city: Thessaloniki
country: Greece
facility: Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic
city: Thessaloniki
country: Greece
facility: "AHEPA" University General Hospital of Thessaloniki
city: Kochi
country: India
facility: Amrita Institute Of Medical Sciences & Research Centre
state: Kerala
city: Pune
country: India
facility: Jehangir Clinical Development Centre
state: Maharashtra
city: New Dehli
country: India
facility: All India Institute of Medical Sciences
state: New Delhi
city: Cork
country: Ireland
facility: Cork University Hospital
city: Beer Sheva
country: Israel
facility: Soroka Medical Center - Pediatric Endocrinology
city: Haifa
country: Israel
facility: Rambam Medical Center Children A Dept.
city: Petah Tikva
country: Israel
facility: Endrocrinology & DM Schneider MC
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center Pediatric Endocrinology
city: Zerifin
country: Israel
facility: Shamir (Assaf Harofe) Medical Center
city: Firenze
country: Italy
facility: IRCCS Meyer Firenze
city: Milano
country: Italy
facility: Ospedale San Raffaele UO di Pediatria e UO di Neonatologia
city: Napoli
country: Italy
facility: Università degli Studi della Campania "L. Vanvitelli"
city: Roma
country: Italy
facility: Bambin Gesù
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Fukuoka Children's Hospital
city: Kobe-shi, Hyogo
country: Japan
facility: Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo
city: Kyoto
country: Japan
facility: Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics
city: Nara-shi, Nara
country: Japan
facility: Nara Prefecture General Medical Center
city: Niigata-shi, Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital, Pediatrics
city: Okayama-shi, Okayama
country: Japan
facility: Okayama Medical Center
city: Osaka
country: Japan
facility: Osaka City General Hospital, Pediatric Endocrinology and Me
city: Osaka
country: Japan
facility: Osaka Women's and Children's Hospital
city: Saitama-shi, Saitama
country: Japan
facility: Saitama Children's Medical Center, Endocrinorogy&Metabolism
city: Sapporo, Hokkaido
country: Japan
facility: Hokkaido University Hospital, Pediatrics
city: Shizuoka-shi, Shizuoka
country: Japan
facility: Shizuoka Children's Hospital, Department of Diabetes and metabolism
city: Tokyo
country: Japan
facility: Institute of Science Tokyo Hospital
city: Tokyo
country: Japan
facility: National Center for Child Health and Dev, Endo and Metabo
city: Toyoake, Aichi
country: Japan
facility: Fujita Health University Hospital, Pediatrics
city: Sejong-si
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Riga
country: Latvia
facility: Children's Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan
state: Kelantan
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Bandar Puncak Alam Selangor Darul Ehsan
country: Malaysia
facility: University Technology MARA (UiTM) - Puncak Alam
city: Bandar Puncak Alam Selangor Darul Ehsan
country: Malaysia
facility: University Technology MARA (UiTM) - Sg Buloh
city: Puebla
country: Mexico
facility: Consultorio de Endocrinología y Pediatría
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rzeszow
country: Poland
facility: Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
state: Podkarpackie Voivodeship
city: Cracow
country: Poland
facility: Uniwer. Szpital Dzieciecy Klinika Endokry. Dzieci i Mlodzie
city: Gdansk
country: Poland
facility: UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,
city: Lodz
country: Poland
facility: Klinika Endokrynologii i Chorób Metabolicznych
city: Szczecin
country: Poland
facility: SPSK nr 1 im Prof. T Sokolowskiego
city: Zabrze
country: Poland
facility: Klinika Pediatrii SUM, SPSK nr 1 im. prof.S.Szyszko w Zabrzu_LOC#1
city: Zabrze
country: Poland
facility: SPSK nr 1 im. prof.S.Szyszko w Zabrzu
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Central - Hospital Dona Estefânia
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte
city: Lisboa
country: Portugal
facility: Unidade Local De Saude De Santa Maria E.P.E.
city: Porto
country: Portugal
facility: Unidade Local de Saúde de Santo António, E.P.E
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre, Riyadh
city: Riyadh
country: Saudi Arabia
facility: National Guard Hospital
city: Nis
country: Serbia
facility: University Clinical Centre Nis
state: RS
city: Belgrade
country: Serbia
facility: University Children's Hospital Tirsova
city: Belgrade
country: Serbia
facility: Institute for Mother and Child Health Care of Serbia
city: Kragujevac
country: Serbia
facility: University Clinical Centre Kragujevac
city: Nis
country: Serbia
facility: University Clinical Centre Nis
city: Novi Sad
country: Serbia
facility: Institute for Health Care of Children and Adolescents
city: Ljubljana
country: Slovenia
facility: PeK - Dept. of Paediatric Endocrinology, Diabetes and Metabolism
city: Ljubljana
country: Slovenia
facility: University Children's Hospital
city: Johannesburg
country: South Africa
facility: Department of Peadiatrics CHBAH
state: Gauteng
city: Pretoria
country: South Africa
facility: Dr JC van Dyk's Rooms
state: Gauteng
city: Mayville
country: South Africa
facility: Dr Y Ganie's site
state: KwaZulu-Natal
city: Westville
country: South Africa
facility: Dr K Pillay's site
state: KwaZulu-Natal
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: A Coruña
city: Boadilla del Monte
country: Spain
facility: Hospital Madrid Montepríncipe
state: Madrid
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
city: Bern
country: Switzerland
facility: Med. Kinder- und Poliklinik
city: Ratchathewi
country: Thailand
facility: Ramathibodi Hospital - Ped-Endo and Metabolism
state: Bangkok
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial hospital-Ped-Endocrinology
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital - Paediatrics Endocrinology Centre
city: Bangkok
country: Thailand
facility: Siriraj Hospital_Bangkok_0
city: Chiang Mai
country: Thailand
facility: Department of Pediatrics, Chiang Mai
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital_Cambridge
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary_Hull
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
city: London
country: United Kingdom
facility: Evelina Children's Hospital - St Thomas'
city: London
country: United Kingdom
facility: Evelina London Children's Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Tooting
country: United Kingdom
facility: St Georges Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: