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Clinical Trial Details

Trial ID: L2672
Source ID: NCT04029480
Associated Drug: Ertugliflozin 5 Mg
Title: Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Ertugliflozin 5 mg|DRUG: Ertugliflozin 15 mg|DRUG: Placebo to ertugliflozin 15 mg|DRUG: Placebo to ertugliflozin 5 mg|BIOLOGICAL: Insulin|DRUG: Metformin
Outcome Measures: Primary: Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin 5 mg and 15 mg versus placebo), Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples are collected at baseline and Week 24 to determine the least squares mean HbA1C change from baseline (i.e., HbA1C at Week 24 minus HbA1C at baseline)., Baseline and 24 weeks|Number of Participants Who Experience an Adverse Event (AE) over 24 weeks, An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event., Up to 24 weeks|Number of Participants Who Experience an AE over 54 weeks, An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event., Up to 54 weeks|Number of Participants Who Discontinue Study Treatment Due to an AE over 24 weeks, An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event., Up to 24 weeks|Number of Participants Who Discontinue Study Treatment Due to an AE over 54 weeks, An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event., Up to 54 weeks | Secondary: Change from Baseline in Hemoglobin A1C at Week 24 (dose-optimized ertugliflozin versus placebo), Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples are collected at baseline and Week 24 to determine the least squares mean HbA1C change from baseline (i.e., HbA1C at Week 24 minus HbA1C at baseline)., Baseline and 24 weeks|Change from Baseline in Hemoglobin A1C at Week 24 (ertugliflozin 5 mg versus placebo), Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples are collected at baseline and Week 24 to determine the least squares mean HbA1C change from baseline (i.e., HbA1C at Week 24 minus HbA1C at baseline)., Baseline and 24 weeks|Change from Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks, Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood is drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline)., Baseline and 24 weeks|Change from Baseline in Hemoglobin A1C at 54 Weeks, Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples are collected at baseline and Week 54 to determine the least squares mean HbA1C change from baseline (i.e., HbA1C at Week 54 minus HbA1C at baseline)., Baseline and 54 weeks|Change from Baseline in FPG at 54 Weeks, Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood is drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline)., Baseline and 54 weeks
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC | Collaborators: Pfizer
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 165
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-10-08
Completion Date: 2025-04-10
Results First Posted:
Last Update Posted: 2025-03-20
Locations: The University of Alabama at Birmingham ( Site 2207), Birmingham, Alabama, 35233-1711, United States|Children's Hospital - Los Angeles ( Site 2201), Los Angeles, California, 90027, United States|Center of Excellence in Diabetes and Endocrinology ( Site 2203), Sacramento, California, 95821, United States|Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si, Hollywood, Florida, 33021, United States|ICCT Research International, Inc. ( Site 2211), Chicago, Illinois, 60659, United States|Barry J. Reiner MD LLC ( Site 2204), Baltimore, Maryland, 21229, United States|William Beaumont Hospital ( Site 2219), Royal Oak, Michigan, 48073, United States|CHEAR Center LLC ( Site 2200), Bronx, New York, 10455, United States|Coastal Children''s Services ( Site 2202), Wilmington, North Carolina, 28403, United States|The Children's Hospital of Philadelphia ( Site 2205), Philadelphia, Pennsylvania, 19104, United States|Southern Endocrinology and Associates PA ( Site 2218), Mesquite, Texas, 75149, United States|Cliniques Universitaires Saint-Luc ( Site 2300), Brussels, Bruxelles-Capitale, Region De, 1200, Belgium|London Health Sciences Centre ( Site 0002), London, Ontario, N6A 5W9, Canada|Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001), Montreal, Quebec, H1T 2M4, Canada|Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101), Barranquilla, Atlantico, 080020, Colombia|MedPlus Medicina Prepagada S.A. ( Site 0102), Bogota, Distrito Capital De Bogota, 110221, Colombia|Clinica Los Yoses ( Site 0200), San Jose, 11501, Costa Rica|Hospital Infantil Dr. Robert Reid Cabral ( Site 0300), Santo Domingo, Distrito Nacional, 10101, Dominican Republic|CHU du BOCAGE ( Site 0407), Dijon, Cote-d Or, 21079, France|CHU Amiens Hopital Sud ( Site 0413), Amiens, Picardie, 80054, France|Consultorio Privado Dr. Geraldine Utrilla ( Site 0501), Chiquimula, 20001, Guatemala|Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502), Guatemala City, 01014, Guatemala|Endopedia ( Site 0503), Guatemala, 01009, Guatemala|Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708), Pecs, Baranya, 7623, Hungary|Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705), Békéscsaba, Bekescsaba, 5600, Hungary|Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701), Miskolc, Borsod-Abauj-Zemplen, 3526, Hungary|Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706), Székesfehérvár, Fejer, 8000, Hungary|Petz Aladar Megyei Oktato Korhaz ( Site 0709), Gyor, Gyor-Moson-Sopron, 9023, Hungary|Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 0704), Nyiregyhaza, Szabolcs-Szatmar-Bereg, 4400, Hungary|Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702), Budapest, 1089, Hungary|Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703), Budapest, 1094, Hungary|Soroka University Medical Center ( Site 0802), Beer Sheva, 8410101, Israel|Armon M.C ( Site 0803), Haifa, 3350121, Israel|Rambam Medical Center ( Site 0801), Haifa, 3525408, Israel|Hadassah Mount Scopus ( Site 0800), Jerusalem, 9124001, Israel|The Edmond and Lily Safra Children s Hospital ( Site 0804), Ramat Gan, 5265601, Israel|A.O.Universitaria Meyer ( Site 0901), Firenze, Toscana, 50139, Italy|U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904), Caltanissetta, 93100, Italy|IRCCS G. Gaslini ( Site 0900), Genova, 16147, Italy|AOU Federico II di Napoli ( Site 0902), Napoli, 80123, Italy|IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903), Roma, 00165, Italy|Ospedale Regina Margherita ( Site 0905), Torino, 10126, Italy|Hospital Universiti Sains Malaysia ( Site 1102), Kubang Kerian, Kelantan, 16150, Malaysia|Hospital Taiping ( Site 1104), Taiping, Perak, 34000, Malaysia|Hospital Pulau Pinang. ( Site 1101), Georgetown, Pulau Pinang, 10990, Malaysia|Hospital Putrajaya ( Site 1103), Putrajaya, Wilayah Persekutuan Putrajaya, 62000, Malaysia|University Malaya Medical Centre ( Site 1100), Kuala Lumpur, 59100, Malaysia|Life Nova+ ( Site 1203), Forbach, Pamplemousses, 21014, Mauritius|Wellkin Hospital ( Site 1200), Moka, 80812, Mauritius|Bio Investigación AMARC, S.C. ( Site 1006), Ciudad de México, Distrito Federal, 11410, Mexico|CAIMED Investigación en Salud S.A de C.V ( Site 1008), Mexico, Distrito Federal, 06760, Mexico|Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007), Guadalajara, Jalisco, 44150, Mexico|Centro de Investigacion Medica de Occidente S.C. ( Site 1001), Guadalajara, Jalisco, 44260, Mexico|Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005), Monterrey, Nuevo Leon, 64460, Mexico|Unidad de Medicina Especializada SMA ( Site 1004), San Juan del Río, Queretaro, 76800, Mexico|Consultorio Medico de Endocrinologia Pediatrica ( Site 1002), Culiacan, Sinaloa, 80000, Mexico|Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003), Madero, Tamaulipas, 89440, Mexico|Centro de Investigacion Medica Aguascalientes ( Site 1000), Aguascalientes, 20116, Mexico|Centro de Atencion e Investigacion Clinica SC ( Site 1009), Aguascalientes, 20119, Mexico|Davao Doctors Hospital ( Site 1400), Davao City, Davao Del Sur, 8000, Philippines|Institute for Studies on Diabetes Foundation Inc. ( Site 1402), Marikina, National Capital Region, 1810, Philippines|West Visayas State University Medical Center ( Site 1401), Iloilo, 5000, Philippines|IN VIVO ( Site 1501), Bydgoszcz, Kujawsko-pomorskie, 85-046, Poland|Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500), Wierzchoslawice, Malopolskie, 33-122, Poland|Instytut Diabetologii Sp z o o ( Site 1512), Warszawa, Mazowieckie, 02-117, Poland|Clinical Medical Research Sp. z o.o. ( Site 1511), Katowice, Slaskie, 40-156, Poland|Bashkir State Medical University Hospital ( Site 1603), Ufa, Baskortostan, Respublika, 450083, Russian Federation|Federal State Budget Institution Endocrinological Research Center ( Site 1611), Moscow, Moskva, 117036, Russian Federation|Children's City Clinical Hospital #1 ( Site 1604), Novosibirsk, Novosibirskaya Oblast, 630048, Russian Federation|Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606), Rostov-on-Don, Rostovskaya Oblast, 344012, Russian Federation|Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610), Samara, Samarskaya Oblast, 443079, Russian Federation|St.Petersburg State Pediatric Medical University ( Site 1600), Saint Petersburg, Sankt-Peterburg, 194100, Russian Federation|Kazan State Medical University ( Site 1601), Kazan, Tatarstan, Respublika, 420029, Russian Federation|Siberian State Medical University ( Site 1602), Tomsk, Tomskaya Oblast, 634050, Russian Federation|Voronezh State Medical University named after N.N.Burdenko ( Site 1608), Voronezh, Voronezskaja Oblast, 394024, Russian Federation|Hera General Hospital ( Site 1725), Mecca, Al BaHah, 24211, Saudi Arabia|King Abdulaziz Medical City - Al Ahsa ( Site 1730), Al Ahsa, Ar Riyad, 31982, Saudi Arabia|King Abdul Aziz Medical City - AlRiyadh ( Site 1700), Riyadh, Ar Riyad, 11426, Saudi Arabia|King Abdul Aziz Medical City - AlRiyadh ( Site 1705), Riyadh, Ar Riyad, 11426, Saudi Arabia|King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720), Riyadh, Ar Riyad, 11564, Saudi Arabia|King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710), Riyadh, Ar Riyad, 11564, Saudi Arabia|King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715), Jeddah, Makkah Al Mukarramah, 21423, Saudi Arabia|I. U. Cerrahpasa Tip Fakultesi ( Site 2406), Istambul, Istanbul, 34098, Turkey|Cukurova Uni. Tip Fakultesi ( Site 2403), Adana, 01330, Turkey|Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407), Ankara, 06800, Turkey|Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400), Istanbul, 34854, Turkey|Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (, Chernivtsi, Chernivetska Oblast, 58002, Ukraine|SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914), Dnipro, Dnipropetrovska Oblast, 49100, Ukraine|MHI Regional Childrens Clinical Hospital ( Site 1908), Kharkiv, Kharkivska Oblast, 61093, Ukraine|Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915), Kharkiv, Kharkivska Oblast, 61153, Ukraine|Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903), Kyiv, Kyivska Oblast, 01021, Ukraine|Medical Center Verum ( Site 1913), Kyiv, Kyivska Oblast, 03039, Ukraine|Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905), Kyiv, Kyivska Oblast, 04114, Ukraine|Odessa Regional Children Clinical Hospital ( Site 1912), Odesa, Odeska Oblast, 65031, Ukraine|Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901), Vinnytsia, Vinnytska Oblast, 21010, Ukraine|Dubai Diabetes Center ( Site 2002), Dubai, Dubayy, 215252, United Arab Emirates|Mustafa Al Qaysi Medical Centre ( Site 2010), Dubai, Dubayy, 445498, United Arab Emirates|Mediclinic City Hospital ( Site 2005), Dubai, Dubayy, 505004, United Arab Emirates|Al Jalila Children s Specialty Hospital ( Site 2004), Dubai, Dubayy, 7662, United Arab Emirates|Thumbay University Hospital ( Site 2001), Ajman, 4184, United Arab Emirates|Rashid Center For Diabetes and Research ( Site 2006), Ajman, 5166, United Arab Emirates|Royal London Hospital (Whitechapel) ( Site 2100), London, London, City Of, E1 1FR, United Kingdom|Chelsea and Westminster Hospital ( Site 2103), London, London, City Of, SW10 9NH, United Kingdom|West Middlesex University Hospital ( Site 2104), London, London, City Of, TW7 6AF, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04029480

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details