165
Participants
Start Date
October 8, 2019
Primary Completion Date
April 11, 2025
Study Completion Date
April 11, 2025
Ertugliflozin 5 mg
Ertugliflozin 5 mg, oral, 1 tablet QD
Ertugliflozin 15 mg
Ertugliflozin 15 mg, oral, 1 tablet QD
Placebo to ertugliflozin 15 mg
Placebo to ertugliflozin 15 mg, oral, 1 tablet QD
Placebo to ertugliflozin 5 mg
Placebo to ertugliflozin 5 mg, oral, 1 tablet QD
Insulin
The initiation and titration of insulin will be at the discretion of the investigator, based on local/regional/country guidelines.
Metformin
Participants will receive stable dose of background metformin.
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702), Budapest
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703), Budapest
Cliniques Universitaires Saint-Luc ( Site 2300), Brussels
Institute for Studies on Diabetes Foundation Inc. ( Site 1402), Marikina City
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701), Miskolc
Thumbay University Hospital ( Site 2001), Ajman
Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 0704), Nyíregyháza
West Visayas State University Medical Center ( Site 1401), Iloilo City
Rashid Center For Diabetes and Research ( Site 2006), Ajman
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705), Békéscsaba
Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708), Pécs
Al Jalila Children s Specialty Hospital ( Site 2004), Dubai
Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706), Székesfehérvár
Davao Doctors Hospital ( Site 1400), Davao City
Petz Aladar Megyei Oktato Korhaz ( Site 0709), Győr
Hospital Infantil Dr. Robert Reid Cabral ( Site 0300), Santo Domingo
Ospedale Regina Margherita ( Site 0905), Torino
CHEAR Center LLC ( Site 2200), The Bronx
Hospital Pulau Pinang. ( Site 1101), George Town
Bio Investigación AMARC, S.C. ( Site 1006), Mexico City
King Abdul Aziz Medical City - AlRiyadh ( Site 1700), Riyadh
King Abdul Aziz Medical City - AlRiyadh ( Site 1705), Riyadh
Clinica Los Yoses ( Site 0200), San José
King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720), Riyadh
King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710), Riyadh
IRCCS G. Gaslini ( Site 0900), Genova
Hospital Universiti Sains Malaysia ( Site 1102), Kubang Kerian
The Children's Hospital of Philadelphia ( Site 2205), Philadelphia
Consultorio Privado Dr. Geraldine Utrilla ( Site 0501), Chiquimula
Centro de Investigacion Medica Aguascalientes ( Site 1000), Aguascalientes
Centro de Atencion e Investigacion Clinica SC ( Site 1009), Aguascalientes
Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901), Vinnytsia
Life Nova+ ( Site 1203), Forbach
CHU du BOCAGE ( Site 0407), Dijon
Barry J. Reiner MD LLC ( Site 2204), Baltimore
King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715), Jeddah
Hera General Hospital ( Site 1725), Mecca
Coastal Children''s Services ( Site 2202), Wilmington
King Abdulaziz Medical City - Al Ahsa ( Site 1730), Al Ahsa
Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si, Hollywood
Hospital Taiping ( Site 1104), Taiping
I. U. Cerrahpasa Tip Fakultesi ( Site 2406), Istanbul
Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400), Istanbul
Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007), Guadalajara
Centro de Investigacion Medica de Occidente S.C. ( Site 1001), Guadalajara
William Beaumont Hospital ( Site 2219), Royal Oak
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914), Dnipro
A.O.Universitaria Meyer ( Site 0901), Florence
Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (, Chernivtsi
University Malaya Medical Centre ( Site 1100), Kuala Lumpur
ICCT Research International, Inc. ( Site 2211), Chicago
MHI Regional Childrens Clinical Hospital ( Site 1908), Kharkiv
Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915), Kharkiv
Hospital Putrajaya ( Site 1103), Putrajaya
Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005), Monterrey
Odessa Regional Children Clinical Hospital ( Site 1912), Odesa
Southern Endocrinology and Associates PA ( Site 2218), Mesquite
Unidad de Medicina Especializada SMA ( Site 1004), San Juan del Río
Consultorio Medico de Endocrinologia Pediatrica ( Site 1002), Culiacán
CHU Amiens Hopital Sud ( Site 0413), Amiens
AOU Federico II di Napoli ( Site 0902), Napoli
Wellkin Hospital ( Site 1200), Moka
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003), Madero
Children's Hospital - Los Angeles ( Site 2201), Los Angeles
U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904), Caltanissetta
Center of Excellence in Diabetes and Endocrinology ( Site 2203), Sacramento
MedPlus Medicina Prepagada S.A. ( Site 0102), Bogotá
Federal State Budget Institution Endocrinological Research Center ( Site 1611), Moscow
St.Petersburg State Pediatric Medical University ( Site 1600), Saint Petersburg
Dubai Diabetes Center ( Site 2002), Dubai
Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606), Rostov-on-Don
Voronezh State Medical University named after N.N.Burdenko ( Site 1608), Voronezh
Kazan State Medical University ( Site 1601), Kazan'
Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610), Samara
Mustafa Al Qaysi Medical Centre ( Site 2010), Dubai
Bashkir State Medical University Hospital ( Site 1603), Ufa
Mediclinic City Hospital ( Site 2005), Dubai
Children's City Clinical Hospital #1 ( Site 1604), Novosibirsk
Siberian State Medical University ( Site 1602), Tomsk
Armon M.C ( Site 0803), Haifa
Rambam Medical Center ( Site 0801), Haifa
The Edmond and Lily Safra Children s Hospital ( Site 0804), Ramat Gan
Soroka University Medical Center ( Site 0802), Beersheba
Hadassah Mount Scopus ( Site 0800), Jerusalem
The University of Alabama at Birmingham ( Site 2207), Birmingham
London Health Sciences Centre ( Site 0002), London
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001), Montreal
Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101), Barranquilla
Endopedia ( Site 0503), Guatemala City
Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502), Guatemala City
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903), Roma
CAIMED Investigación en Salud S.A de C.V ( Site 1008), Mexico City
IN VIVO ( Site 1501), Bydgoszcz
Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500), Wierzchosławice
Instytut Diabetologii Sp z o o ( Site 1512), Warsaw
Clinical Medical Research Sp. z o.o. ( Site 1511), Katowice
Cukurova Uni. Tip Fakultesi ( Site 2403), Adana
Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407), Ankara
Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903), Kyiv
Medical Center Verum ( Site 1913), Kyiv
Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905), Kyiv
Royal London Hospital (Whitechapel) ( Site 2100), London
Chelsea and Westminster Hospital ( Site 2103), London
West Middlesex University Hospital ( Site 2104), London
Collaborators (1)
Pfizer
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY