Phase
Condition
Hypertriglyceridemia
Diabetes Prevention
Diabetes And Hypertension
Treatment
Insulin
Metformin
Ertugliflozin 5 mg
Clinical Study ID
Ages 10-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
Has body mass index (BMI) ≥85th percentile at screening OR participant has a historyof being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
T2DM for ≥2 years, OR T2DM for <2 years and a fasting C-peptide value >0.6 ng/mL atScreening.
On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, ORon a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and astable dose of insulin for ≥8 weeks prior to Screening.
Contraceptive use by male participants should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.
Is a non-sterilized female who is currently not sexually active OR who agrees toabstain from heterosexual activity OR who agrees to start contraception prior toinitiating sexual activity and who agrees to use an adequate method ofcontraception. Contraceptive use by females should be consistent with localregulations regarding the methods of contraception for those participating inclinical studies.
Have a family member or adult who, along with the participant, will be closelyinvolved in the participant's daily activities (in the opinion of the investigator)and in the participant's treatment and study procedures.
Exclusion
Exclusion Criteria:
Has known type 1 diabetes mellitus or documented evidence of positive diabetesautoantibodies performed when participant was diagnosed with diabetes.
Has known monogenic diabetes, or secondary diabetes.
Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediateinitiation of another antihyperglycemic agent, including insulin.
Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
Is pregnant, or breast feeding or is expecting to conceive or donate eggs during thestudy, including 14 days following the last dose of study medication.
Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin,empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
Has a history of severe hypoglycemia while on insulin.
Study Design
Connect with a study center
Cliniques Universitaires Saint-Luc ( Site 2300)
Brussels, Bruxelles-Capitale, Region De 1200
BelgiumSite Not Available
London Health Sciences Centre ( Site 0002)
London, Ontario N6A 5W9
CanadaSite Not Available
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)
Montreal, Quebec H1T 2M4
CanadaSite Not Available
Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)
Barranquilla, Atlantico 080020
ColombiaSite Not Available
MedPlus Medicina Prepagada S.A. ( Site 0102)
Bogota, Distrito Capital De Bogota 110221
ColombiaSite Not Available
Clinica Los Yoses ( Site 0200)
San Jose, 11501
Costa RicaSite Not Available
Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)
Santo Domingo, Distrito Nacional 10101
Dominican RepublicSite Not Available
CHU du BOCAGE ( Site 0407)
Dijon, Cote-d Or 21079
FranceSite Not Available
CHU Amiens Hopital Sud ( Site 0413)
Amiens, Picardie 80054
FranceSite Not Available
Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)
Chiquimula, 20001
GuatemalaSite Not Available
Clinicas Las Americas ( Site 0502)
Guatemala, 01014
GuatemalaActive - Recruiting
Endopedia ( Site 0503)
Guatemala, 01009
GuatemalaSite Not Available
Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502)
Guatemala City, 01014
GuatemalaSite Not Available
Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)
Pecs, Baranya 7623
HungarySite Not Available
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705)
Békéscsaba, Bekescsaba 5600
HungarySite Not Available
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)
Miskolc, Borsod-Abauj-Zemplen 3526
HungarySite Not Available
Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)
Szekesfehervar, Fejer 8000
HungarySite Not Available
Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)
Székesfehérvár, Fejer 8000
HungarySite Not Available
Petz Aladar Megyei Oktato Korhaz ( Site 0709)
Gyor, Gyor-Moson-Sopron 9023
HungarySite Not Available
Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktato korhaz ( Site 0704)
Nyiregyhaza, Szabolcs-Szatmar-Bereg 4400
HungaryActive - Recruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 0704)
Nyiregyhaza, Szabolcs-Szatmar-Bereg 4400
HungarySite Not Available
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)
Budapest, 1089
HungarySite Not Available
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)
Budapest, 1094
HungarySite Not Available
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0705)
Gyula, 5700
HungarySite Not Available
Soroka University Medical Center ( Site 0802)
Beer Sheva, 8410101
IsraelSite Not Available
Armon M.C ( Site 0803)
Haifa, 3350121
IsraelSite Not Available
Rambam Medical Center ( Site 0801)
Haifa, 3525408
IsraelSite Not Available
Hadassah Mount Scopus ( Site 0800)
Jerusalem, 9124001
IsraelSite Not Available
The Edmond and Lily Safra Children s Hospital ( Site 0804)
Ramat Gan, 5265601
IsraelSite Not Available
A.O.Universitaria Meyer ( Site 0901)
Firenze, Toscana 50139
ItalySite Not Available
U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904)
Caltanissetta, 93100
ItalySite Not Available
IRCCS G. Gaslini ( Site 0900)
Genova, 16147
ItalySite Not Available
AOU Federico II di Napoli ( Site 0902)
Napoli, 80123
ItalySite Not Available
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)
Roma, 00165
ItalySite Not Available
Ospedale Regina Margherita ( Site 0905)
Torino, 10126
ItalySite Not Available
Hospital Universiti Sains Malaysia ( Site 1102)
Kubang Kerian, Kelantan 16150
MalaysiaSite Not Available
Hospital Taiping ( Site 1104)
Taiping, Perak 34000
MalaysiaSite Not Available
Hospital Pulau Pinang. ( Site 1101)
Georgetown, Pulau Pinang 10990
MalaysiaSite Not Available
Hospital Putrajaya ( Site 1103)
Putrajaya, Wilayah Persekutuan Putrajaya 62000
MalaysiaSite Not Available
University Malaya Medical Centre ( Site 1100)
Kuala Lumpur, 59100
MalaysiaSite Not Available
Life Nova+ ( Site 1203)
Forbach, Pamplemousses 21014
MauritiusSite Not Available
Wellkin Hospital ( Site 1200)
Moka, 80812
MauritiusSite Not Available
Bio Investigación AMARC, S.C. ( Site 1006)
Ciudad de México, Distrito Federal 11410
MexicoSite Not Available
CAIMED Investigación en Salud S.A de C.V ( Site 1008)
Mexico, Distrito Federal 06760
MexicoSite Not Available
Centro de Investigacion Medica de Occidente S.C. ( Site 1001)
Guadalajara, Jalisco 44260
MexicoSite Not Available
Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)
Guadalajara, Jalisco 44150
MexicoSite Not Available
Centro de Investigacion Medica de Occidente S.C. ( Site 1001)
Zapopan, Jalisco 45116
MexicoSite Not Available
Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)
Monterrey, Nuevo Leon 64460
MexicoSite Not Available
Unidad de Medicina Especializada SMA ( Site 1004)
San Juan del Río, Queretaro 76800
MexicoSite Not Available
Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)
Culiacan, Sinaloa 80000
MexicoSite Not Available
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)
Madero, Tamaulipas 89440
MexicoSite Not Available
Centro de Atencion e Investigacion Clinica SC ( Site 1009)
Aguascalientes, 20119
MexicoSite Not Available
Centro de Investigacion Medica Aguascalientes ( Site 1000)
Aguascalientes, 20116
MexicoSite Not Available
Centro de Diagnostico Medicont S.A. de C.V ( Site 1006)
Mexico City, 11410
MexicoSite Not Available
Radiologia Total SAPI de CV ( Site 1004)
Queretaro, 76000
MexicoSite Not Available
Davao Doctors Hospital ( Site 1400)
Davao City, Davao Del Sur 8000
PhilippinesSite Not Available
Institute for Studies on Diabetes Foundation Inc. ( Site 1402)
Marikina, National Capital Region 1810
PhilippinesSite Not Available
Davao Doctors Hospital ( Site 1400)
Davao, 8000
PhilippinesSite Not Available
West Visayas State University Medical Center ( Site 1401)
Iloilo, 5000
PhilippinesSite Not Available
IN VIVO ( Site 1501)
Bydgoszcz, Kujawsko-pomorskie 85-046
PolandSite Not Available
Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)
Wierzchoslawice, Malopolskie 33-122
PolandSite Not Available
Instytut Diabetologii Sp z o o ( Site 1512)
Warszawa, Mazowieckie 02-117
PolandSite Not Available
Clinical Medical Research Sp. z o.o. ( Site 1511)
Katowice, Slaskie 40-156
PolandSite Not Available
Bashkir State Medical University Hospital ( Site 1603)
Ufa, Baskortostan, Respublika 450083
Russian FederationSite Not Available
Federal State Budget Institution Endocrinological Research Center ( Site 1611)
Moscow, Moskva 117036
Russian FederationSite Not Available
Children's City Clinical Hospital #1 ( Site 1604)
Novosibirsk, Novosibirskaya Oblast 630048
Russian FederationSite Not Available
Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)
Rostov-on-Don, Rostovskaya Oblast 344012
Russian FederationSite Not Available
Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)
Samara, Samarskaya Oblast 443079
Russian FederationSite Not Available
St.Petersburg State Pediatric Medical University ( Site 1600)
Saint Petersburg, Sankt-Peterburg 194100
Russian FederationSite Not Available
Kazan State Medical University ( Site 1601)
Kazan, Tatarstan, Respublika 420029
Russian FederationSite Not Available
Siberian State Medical University ( Site 1602)
Tomsk, Tomskaya Oblast 634050
Russian FederationSite Not Available
Voronezh State Medical University named after N.N.Burdenko ( Site 1608)
Voronezh, Voronezskaja Oblast 394024
Russian FederationSite Not Available
Hera General Hospital ( Site 1725)
Mecca, Al BaHah 24211
Saudi ArabiaSite Not Available
King Abdulaziz Medical City - Al Ahsa ( Site 1730)
Al Ahsa, Ar Riyad 31982
Saudi ArabiaSite Not Available
King Abdul Aziz Medical City - AlRiyadh ( Site 1700)
Riyadh, Ar Riyad 11426
Saudi ArabiaSite Not Available
King Abdul Aziz Medical City - AlRiyadh ( Site 1705)
Riyadh, Ar Riyad 11426
Saudi ArabiaSite Not Available
King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)
Riyadh, Ar Riyad 11564
Saudi ArabiaSite Not Available
King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)
Riyadh, Ar Riyad 11564
Saudi ArabiaSite Not Available
King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)
Jeddah, Makkah Al Mukarramah 21423
Saudi ArabiaSite Not Available
I. U. Cerrahpasa Tip Fakultesi ( Site 2406)
Istambul, Istanbul 34098
TurkeySite Not Available
Cukurova Uni. Tip Fakultesi ( Site 2403)
Adana, 01330
TurkeySite Not Available
Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407)
Ankara, 06800
TurkeySite Not Available
Ankara City Hospital ( Site 2407)
Ankara, 06800
TurkeyActive - Recruiting
Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400)
Istanbul, 34854
TurkeySite Not Available
Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (
Chernivtsi, Chernivetska Oblast 58002
UkraineSite Not Available
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)
Dnipro, Dnipropetrovska Oblast 49100
UkraineSite Not Available
Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915)
Kharkiv, Kharkivska Oblast 61153
UkraineSite Not Available
MHI Regional Childrens Clinical Hospital ( Site 1908)
Kharkiv, Kharkivska Oblast 61093
UkraineSite Not Available
Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)
Kyiv, Kyivska Oblast 04114
UkraineSite Not Available
Medical Center Verum ( Site 1913)
Kyiv, Kyivska Oblast 03039
UkraineSite Not Available
Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)
Kyiv, Kyivska Oblast 01021
UkraineSite Not Available
Odessa Regional Children Clinical Hospital ( Site 1912)
Odesa, Odeska Oblast 65031
UkraineSite Not Available
Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)
Vinnytsia, Vinnytska Oblast 21010
UkraineSite Not Available
Al Jalila Children s Specialty Hospital ( Site 2004)
Dubai, Dubayy 7662
United Arab EmiratesSite Not Available
Dubai Diabetes Center ( Site 2002)
Dubai, Dubayy 215252
United Arab EmiratesSite Not Available
Mediclinic City Hospital ( Site 2005)
Dubai, Dubayy 505004
United Arab EmiratesSite Not Available
Mustafa Al Qaysi Medical Centre ( Site 2010)
Dubai, Dubayy 445498
United Arab EmiratesSite Not Available
Rashid Center For Diabetes and Research ( Site 2006)
Ajman, 5166
United Arab EmiratesSite Not Available
Thumbay University Hospital ( Site 2001)
Ajman, 4184
United Arab EmiratesSite Not Available
Chelsea and Westminster Hospital ( Site 2103)
London, London, City Of SW10 9NH
United KingdomSite Not Available
Royal London Hospital (Whitechapel) ( Site 2100)
London, London, City Of E1 1FR
United KingdomSite Not Available
West Middlesex University Hospital ( Site 2104)
London, London, City Of TW7 6AF
United KingdomSite Not Available
The University of Alabama at Birmingham ( Site 2207)
Birmingham, Alabama 35233-1711
United StatesSite Not Available
Children's Hospital - Los Angeles ( Site 2201)
Los Angeles, California 90027
United StatesSite Not Available
Center of Excellence in Diabetes and Endocrinology ( Site 2203)
Sacramento, California 95821
United StatesSite Not Available
Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si
Hollywood, Florida 33021
United StatesSite Not Available
ICCT Research International, Inc. ( Site 2211)
Chicago, Illinois 60659
United StatesSite Not Available
Barry J. Reiner MD LLC ( Site 2204)
Baltimore, Maryland 21229
United StatesSite Not Available
William Beaumont Hospital ( Site 2219)
Royal Oak, Michigan 48073
United StatesSite Not Available
CHEAR Center LLC ( Site 2200)
Bronx, New York 10455
United StatesSite Not Available
Coastal Children''s Services ( Site 2202)
Wilmington, North Carolina 28403
United StatesSite Not Available
The Children's Hospital of Philadelphia ( Site 2205)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Southern Endocrinology and Associates PA ( Site 2218)
Mesquite, Texas 75149
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.