Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)

Last updated: May 8, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Diabetes Prevention

Diabetes And Hypertension

Treatment

Insulin

Metformin

Ertugliflozin 5 mg

Clinical Study ID

NCT04029480
8835-059
2017-003455-35
2022-501085-21
PHRR190913-002184
U1111-1279-3984
MK-8859-059
2022-501085-21-00
  • Ages 10-17
  • All Genders

Study Summary

This study will evaluate the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study is that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.

  2. 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).

  3. T2DM for ≥2 years, OR T2DM for <2 years and a fasting C-peptide value >0.6 ng/mL atScreening.

  4. 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.

  5. Contraceptive use by male participants should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

  6. 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.

  7. 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:

  1. Has known type 1 diabetes mellitus or documented evidence of positive diabetesautoantibodies performed when participant was diagnosed with diabetes.

  2. Has known monogenic diabetes, or secondary diabetes.

  3. Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediateinitiation of another antihyperglycemic agent, including insulin.

  4. Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.

  5. 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.

  6. Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin,empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.

  7. Has a history of idiopathic acute pancreatitis or chronic pancreatitis.

  8. Has a history of severe hypoglycemia while on insulin.

Study Design

Total Participants: 165
Treatment Group(s): 10
Primary Treatment: Insulin
Phase: 3
Study Start date:
October 08, 2019
Estimated Completion Date:
April 11, 2025

Connect with a study center

  • Cliniques Universitaires Saint-Luc ( Site 2300)

    Brussels, Bruxelles-Capitale, Region De 1200
    Belgium

    Site Not Available

  • London Health Sciences Centre ( Site 0002)

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)

    Barranquilla, Atlantico 080020
    Colombia

    Site Not Available

  • MedPlus Medicina Prepagada S.A. ( Site 0102)

    Bogota, Distrito Capital De Bogota 110221
    Colombia

    Site Not Available

  • Clinica Los Yoses ( Site 0200)

    San Jose, 11501
    Costa Rica

    Site Not Available

  • Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)

    Santo Domingo, Distrito Nacional 10101
    Dominican Republic

    Site Not Available

  • CHU du BOCAGE ( Site 0407)

    Dijon, Cote-d Or 21079
    France

    Site Not Available

  • CHU Amiens Hopital Sud ( Site 0413)

    Amiens, Picardie 80054
    France

    Site Not Available

  • Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)

    Chiquimula, 20001
    Guatemala

    Site Not Available

  • Clinicas Las Americas ( Site 0502)

    Guatemala, 01014
    Guatemala

    Active - Recruiting

  • Endopedia ( Site 0503)

    Guatemala, 01009
    Guatemala

    Site Not Available

  • Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502)

    Guatemala City, 01014
    Guatemala

    Site Not Available

  • Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)

    Pecs, Baranya 7623
    Hungary

    Site Not Available

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705)

    Békéscsaba, Bekescsaba 5600
    Hungary

    Site Not Available

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)

    Miskolc, Borsod-Abauj-Zemplen 3526
    Hungary

    Site Not Available

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)

    Szekesfehervar, Fejer 8000
    Hungary

    Site Not Available

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)

    Székesfehérvár, Fejer 8000
    Hungary

    Site Not Available

  • Petz Aladar Megyei Oktato Korhaz ( Site 0709)

    Gyor, Gyor-Moson-Sopron 9023
    Hungary

    Site Not Available

  • Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktato korhaz ( Site 0704)

    Nyiregyhaza, Szabolcs-Szatmar-Bereg 4400
    Hungary

    Active - Recruiting

  • Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 0704)

    Nyiregyhaza, Szabolcs-Szatmar-Bereg 4400
    Hungary

    Site Not Available

  • Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)

    Budapest, 1089
    Hungary

    Site Not Available

  • Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)

    Budapest, 1094
    Hungary

    Site Not Available

  • Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0705)

    Gyula, 5700
    Hungary

    Site Not Available

  • Soroka University Medical Center ( Site 0802)

    Beer Sheva, 8410101
    Israel

    Site Not Available

  • Armon M.C ( Site 0803)

    Haifa, 3350121
    Israel

    Site Not Available

  • Rambam Medical Center ( Site 0801)

    Haifa, 3525408
    Israel

    Site Not Available

  • Hadassah Mount Scopus ( Site 0800)

    Jerusalem, 9124001
    Israel

    Site Not Available

  • The Edmond and Lily Safra Children s Hospital ( Site 0804)

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • A.O.Universitaria Meyer ( Site 0901)

    Firenze, Toscana 50139
    Italy

    Site Not Available

  • U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904)

    Caltanissetta, 93100
    Italy

    Site Not Available

  • IRCCS G. Gaslini ( Site 0900)

    Genova, 16147
    Italy

    Site Not Available

  • AOU Federico II di Napoli ( Site 0902)

    Napoli, 80123
    Italy

    Site Not Available

  • IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)

    Roma, 00165
    Italy

    Site Not Available

  • Ospedale Regina Margherita ( Site 0905)

    Torino, 10126
    Italy

    Site Not Available

  • Hospital Universiti Sains Malaysia ( Site 1102)

    Kubang Kerian, Kelantan 16150
    Malaysia

    Site Not Available

  • Hospital Taiping ( Site 1104)

    Taiping, Perak 34000
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang. ( Site 1101)

    Georgetown, Pulau Pinang 10990
    Malaysia

    Site Not Available

  • Hospital Putrajaya ( Site 1103)

    Putrajaya, Wilayah Persekutuan Putrajaya 62000
    Malaysia

    Site Not Available

  • University Malaya Medical Centre ( Site 1100)

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Life Nova+ ( Site 1203)

    Forbach, Pamplemousses 21014
    Mauritius

    Site Not Available

  • Wellkin Hospital ( Site 1200)

    Moka, 80812
    Mauritius

    Site Not Available

  • Bio Investigación AMARC, S.C. ( Site 1006)

    Ciudad de México, Distrito Federal 11410
    Mexico

    Site Not Available

  • CAIMED Investigación en Salud S.A de C.V ( Site 1008)

    Mexico, Distrito Federal 06760
    Mexico

    Site Not Available

  • Centro de Investigacion Medica de Occidente S.C. ( Site 1001)

    Guadalajara, Jalisco 44260
    Mexico

    Site Not Available

  • Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)

    Guadalajara, Jalisco 44150
    Mexico

    Site Not Available

  • Centro de Investigacion Medica de Occidente S.C. ( Site 1001)

    Zapopan, Jalisco 45116
    Mexico

    Site Not Available

  • Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)

    Monterrey, Nuevo Leon 64460
    Mexico

    Site Not Available

  • Unidad de Medicina Especializada SMA ( Site 1004)

    San Juan del Río, Queretaro 76800
    Mexico

    Site Not Available

  • Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)

    Culiacan, Sinaloa 80000
    Mexico

    Site Not Available

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)

    Madero, Tamaulipas 89440
    Mexico

    Site Not Available

  • Centro de Atencion e Investigacion Clinica SC ( Site 1009)

    Aguascalientes, 20119
    Mexico

    Site Not Available

  • Centro de Investigacion Medica Aguascalientes ( Site 1000)

    Aguascalientes, 20116
    Mexico

    Site Not Available

  • Centro de Diagnostico Medicont S.A. de C.V ( Site 1006)

    Mexico City, 11410
    Mexico

    Site Not Available

  • Radiologia Total SAPI de CV ( Site 1004)

    Queretaro, 76000
    Mexico

    Site Not Available

  • Davao Doctors Hospital ( Site 1400)

    Davao City, Davao Del Sur 8000
    Philippines

    Site Not Available

  • Institute for Studies on Diabetes Foundation Inc. ( Site 1402)

    Marikina, National Capital Region 1810
    Philippines

    Site Not Available

  • Davao Doctors Hospital ( Site 1400)

    Davao, 8000
    Philippines

    Site Not Available

  • West Visayas State University Medical Center ( Site 1401)

    Iloilo, 5000
    Philippines

    Site Not Available

  • IN VIVO ( Site 1501)

    Bydgoszcz, Kujawsko-pomorskie 85-046
    Poland

    Site Not Available

  • Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)

    Wierzchoslawice, Malopolskie 33-122
    Poland

    Site Not Available

  • Instytut Diabetologii Sp z o o ( Site 1512)

    Warszawa, Mazowieckie 02-117
    Poland

    Site Not Available

  • Clinical Medical Research Sp. z o.o. ( Site 1511)

    Katowice, Slaskie 40-156
    Poland

    Site Not Available

  • Bashkir State Medical University Hospital ( Site 1603)

    Ufa, Baskortostan, Respublika 450083
    Russian Federation

    Site Not Available

  • Federal State Budget Institution Endocrinological Research Center ( Site 1611)

    Moscow, Moskva 117036
    Russian Federation

    Site Not Available

  • Children's City Clinical Hospital #1 ( Site 1604)

    Novosibirsk, Novosibirskaya Oblast 630048
    Russian Federation

    Site Not Available

  • Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)

    Rostov-on-Don, Rostovskaya Oblast 344012
    Russian Federation

    Site Not Available

  • Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)

    Samara, Samarskaya Oblast 443079
    Russian Federation

    Site Not Available

  • St.Petersburg State Pediatric Medical University ( Site 1600)

    Saint Petersburg, Sankt-Peterburg 194100
    Russian Federation

    Site Not Available

  • Kazan State Medical University ( Site 1601)

    Kazan, Tatarstan, Respublika 420029
    Russian Federation

    Site Not Available

  • Siberian State Medical University ( Site 1602)

    Tomsk, Tomskaya Oblast 634050
    Russian Federation

    Site Not Available

  • Voronezh State Medical University named after N.N.Burdenko ( Site 1608)

    Voronezh, Voronezskaja Oblast 394024
    Russian Federation

    Site Not Available

  • Hera General Hospital ( Site 1725)

    Mecca, Al BaHah 24211
    Saudi Arabia

    Site Not Available

  • King Abdulaziz Medical City - Al Ahsa ( Site 1730)

    Al Ahsa, Ar Riyad 31982
    Saudi Arabia

    Site Not Available

  • King Abdul Aziz Medical City - AlRiyadh ( Site 1700)

    Riyadh, Ar Riyad 11426
    Saudi Arabia

    Site Not Available

  • King Abdul Aziz Medical City - AlRiyadh ( Site 1705)

    Riyadh, Ar Riyad 11426
    Saudi Arabia

    Site Not Available

  • King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)

    Riyadh, Ar Riyad 11564
    Saudi Arabia

    Site Not Available

  • King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)

    Riyadh, Ar Riyad 11564
    Saudi Arabia

    Site Not Available

  • King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)

    Jeddah, Makkah Al Mukarramah 21423
    Saudi Arabia

    Site Not Available

  • I. U. Cerrahpasa Tip Fakultesi ( Site 2406)

    Istambul, Istanbul 34098
    Turkey

    Site Not Available

  • Cukurova Uni. Tip Fakultesi ( Site 2403)

    Adana, 01330
    Turkey

    Site Not Available

  • Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407)

    Ankara, 06800
    Turkey

    Site Not Available

  • Ankara City Hospital ( Site 2407)

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400)

    Istanbul, 34854
    Turkey

    Site Not Available

  • Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (

    Chernivtsi, Chernivetska Oblast 58002
    Ukraine

    Site Not Available

  • SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)

    Dnipro, Dnipropetrovska Oblast 49100
    Ukraine

    Site Not Available

  • Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915)

    Kharkiv, Kharkivska Oblast 61153
    Ukraine

    Site Not Available

  • MHI Regional Childrens Clinical Hospital ( Site 1908)

    Kharkiv, Kharkivska Oblast 61093
    Ukraine

    Site Not Available

  • Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)

    Kyiv, Kyivska Oblast 04114
    Ukraine

    Site Not Available

  • Medical Center Verum ( Site 1913)

    Kyiv, Kyivska Oblast 03039
    Ukraine

    Site Not Available

  • Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)

    Kyiv, Kyivska Oblast 01021
    Ukraine

    Site Not Available

  • Odessa Regional Children Clinical Hospital ( Site 1912)

    Odesa, Odeska Oblast 65031
    Ukraine

    Site Not Available

  • Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)

    Vinnytsia, Vinnytska Oblast 21010
    Ukraine

    Site Not Available

  • Al Jalila Children s Specialty Hospital ( Site 2004)

    Dubai, Dubayy 7662
    United Arab Emirates

    Site Not Available

  • Dubai Diabetes Center ( Site 2002)

    Dubai, Dubayy 215252
    United Arab Emirates

    Site Not Available

  • Mediclinic City Hospital ( Site 2005)

    Dubai, Dubayy 505004
    United Arab Emirates

    Site Not Available

  • Mustafa Al Qaysi Medical Centre ( Site 2010)

    Dubai, Dubayy 445498
    United Arab Emirates

    Site Not Available

  • Rashid Center For Diabetes and Research ( Site 2006)

    Ajman, 5166
    United Arab Emirates

    Site Not Available

  • Thumbay University Hospital ( Site 2001)

    Ajman, 4184
    United Arab Emirates

    Site Not Available

  • Chelsea and Westminster Hospital ( Site 2103)

    London, London, City Of SW10 9NH
    United Kingdom

    Site Not Available

  • Royal London Hospital (Whitechapel) ( Site 2100)

    London, London, City Of E1 1FR
    United Kingdom

    Site Not Available

  • West Middlesex University Hospital ( Site 2104)

    London, London, City Of TW7 6AF
    United Kingdom

    Site Not Available

  • The University of Alabama at Birmingham ( Site 2207)

    Birmingham, Alabama 35233-1711
    United States

    Site Not Available

  • Children's Hospital - Los Angeles ( Site 2201)

    Los Angeles, California 90027
    United States

    Site Not Available

  • Center of Excellence in Diabetes and Endocrinology ( Site 2203)

    Sacramento, California 95821
    United States

    Site Not Available

  • Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si

    Hollywood, Florida 33021
    United States

    Site Not Available

  • ICCT Research International, Inc. ( Site 2211)

    Chicago, Illinois 60659
    United States

    Site Not Available

  • Barry J. Reiner MD LLC ( Site 2204)

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • William Beaumont Hospital ( Site 2219)

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • CHEAR Center LLC ( Site 2200)

    Bronx, New York 10455
    United States

    Site Not Available

  • Coastal Children''s Services ( Site 2202)

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • The Children's Hospital of Philadelphia ( Site 2205)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Southern Endocrinology and Associates PA ( Site 2218)

    Mesquite, Texas 75149
    United States

    Site Not Available

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