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

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (Ages 10 to 17 Years, Inclusive) With Type 2 Diabetes Mellitus

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Ertugliflozin 5 mg; Drug: Ertugliflozin 15 mg; Drug: Placebo to ertugliflozin 15 mg; Drug: Placebo to ertugliflozin 5 mg; Biological: Insulin; Drug: Metformin

Detailed Description

Participants were randomized on Day 1 to the following arms:

• 5 mg ERTU and placebo to 15 mg ERTU (5 mg Ertugliflozin)
• placebo to 5 mg ERTU and placebo to 15 mg ERTU (Placebo)

At Week 12, participants who met the up-titration criteria were re-randomized to the following arms for Weeks 12 to 54:

• 5 mg ERTU and placebo to 15 mg ERTU (5 mg/5 mg Ertugliflozin)
• 15 mg ERTU and placebo to 5 mg ERTU (5 mg/15 mg Ertugliflozin) Participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU from Week 12 to Week 54.

The placebo arm continued receiving placebo from Week 12 to Week 54.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-Capitale, Region de
    • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
      • Cliniques Universitaires Saint-Luc ( Site 2300)
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre ( Site 0002)
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)
• Colombia
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080020
      • Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 110221
      • MedPlus Medicina Prepagada S.A. ( Site 0102)
• Costa Rica
  • San José, Costa Rica, 11501
    • Clinica Los Yoses ( Site 0200)
• Dominican Republic
  • Nacional
    • Santo Domingo, Nacional, Dominican Republic, 10101
      • Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)
• France
  • Cote-d Or
    • Dijon, Cote-d Or, France, 21079
      • CHU du BOCAGE ( Site 0407)
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Hopital Sud ( Site 0413)
• Guatemala
  • Chiquimula, Guatemala, 20001
    • Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)
  • Guatemala City, Guatemala, 01014
    • Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502)
  • Guatemala City, Guatemala, 01009
    • Endopedia ( Site 0503)
• Hungary
  • Budapest, Hungary, 1089
    • Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)
  • Budapest, Hungary, 1094
    • Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)
  • Baranya
    • Pécs, Baranya, Hungary, 7623
      • Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)
  • Bekescsaba
    • Békéscsaba, Bekescsaba, Hungary, 5600
      • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705)
  • Borsod-Abauj Zemplen county
    • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
      • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)
  • Fejér
    • Székesfehérvár, Fejér, Hungary, 8000
      • Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)
  • Győr-Moson-Sopron
    • Győr, Győr-Moson-Sopron, Hungary, 9023
      • Petz Aladar Megyei Oktato Korhaz ( Site 0709)
  • Szabolcs-Szatmár-Bereg
    • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
      • Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 0704)
• Israel
  • Beersheba, Israel, 8410101
    • Soroka University Medical Center ( Site 0802)
  • Haifa, Israel, 3350121
    • Armon M.C ( Site 0803)
  • Haifa, Israel, 3525408
    • Rambam Medical Center ( Site 0801)
  • Jerusalem, Israel, 9124001
    • Hadassah Mount Scopus ( Site 0800)
  • Ramat Gan, Israel, 5265601
    • The Edmond and Lily Safra Children s Hospital ( Site 0804)
• Italy
  • Caltanissetta, Italy, 93100
    • U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904)
  • Genova, Italy, 16147
    • IRCCS G. Gaslini ( Site 0900)
  • Napoli, Italy, 80123
    • AOU Federico II di Napoli ( Site 0902)
  • Roma, Italy, 00165
    • IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)
  • Torino, Italy, 10126
    • Ospedale Regina Margherita ( Site 0905)
  • Tuscany
    • Florence, Tuscany, Italy, 50139
      • A.O.Universitaria Meyer ( Site 0901)
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre ( Site 1100)
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Hospital Universiti Sains Malaysia ( Site 1102)
  • Perak
    • Taiping, Perak, Malaysia, 34000
      • Hospital Taiping ( Site 1104)
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10990
      • Hospital Pulau Pinang. ( Site 1101)
  • Putrajaya
    • Putrajaya, Putrajaya, Malaysia, 62000
      • Hospital Putrajaya ( Site 1103)
• Mauritius
  • Moka, Mauritius, 80812
    • Wellkin Hospital ( Site 1200)
  • Pamplemousses District
    • Forbach, Pamplemousses District, Mauritius, 21014
      • Life Nova+ ( Site 1203)
• Mexico
  • Aguascalientes, Mexico, 20116
    • Centro de Investigacion Medica Aguascalientes ( Site 1000)
  • Aguascalientes, Mexico, 20119
    • Centro de Atencion e Investigacion Clinica SC ( Site 1009)
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44150
      • Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)
    • Guadalajara, Jalisco, Mexico, 44260
      • Centro de Investigacion Medica de Occidente S.C. ( Site 1001)
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06760
      • CAIMED Investigación en Salud S.A de C.V ( Site 1008)
    • Mexico City, Mexico City, Mexico, 11410
      • Bio Investigación AMARC, S.C. ( Site 1006)
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)
  • Querétaro
    • San Juan del Río, Querétaro, Mexico, 76800
      • Unidad de Medicina Especializada SMA ( Site 1004)
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80000
      • Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)
  • Tamaulipas
    • Madero, Tamaulipas, Mexico, 89440
      • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)
• Philippines
  • Iloilo City, Philippines, 5000
    • West Visayas State University Medical Center ( Site 1401)
  • Davao Del Sur
    • Davao City, Davao Del Sur, Philippines, 8000
      • Davao Doctors Hospital ( Site 1400)
  • National Capital Region
    • Marikina City, National Capital Region, Philippines, 1810
      • Institute for Studies on Diabetes Foundation Inc. ( Site 1402)
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-046
      • IN VIVO ( Site 1501)
  • Lesser Poland Voivodeship
    • Wierzchosławice, Lesser Poland Voivodeship, Poland, 33-122
      • Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-117
      • Instytut Diabetologii Sp z o o ( Site 1512)
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-156
      • Clinical Medical Research Sp. z o.o. ( Site 1511)
• Russia
  • Baskortostan, Respublika
    • Ufa, Baskortostan, Respublika, Russia, 450083
      • Bashkir State Medical University Hospital ( Site 1603)
  • Moscow
    • Moscow, Moscow, Russia, 117036
      • Federal State Budget Institution Endocrinological Research Center ( Site 1611)
  • Novosibirsk Oblast
    • Novosibirsk, Novosibirsk Oblast, Russia, 630048
      • Children's City Clinical Hospital #1 ( Site 1604)
  • Rostov Oblast
    • Rostov-on-Don, Rostov Oblast, Russia, 344012
      • Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)
  • Samara Oblast
    • Samara, Samara Oblast, Russia, 443079
      • Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 194100
      • St.Petersburg State Pediatric Medical University ( Site 1600)
  • Tatarstan, Respublika
    • Kazan', Tatarstan, Respublika, Russia, 420029
      • Kazan State Medical University ( Site 1601)
  • Tomsk Oblast
    • Tomsk, Tomsk Oblast, Russia, 634050
      • Siberian State Medical University ( Site 1602)
  • Voronezskaja Oblast
    • Voronezh, Voronezskaja Oblast, Russia, 394024
      • Voronezh State Medical University named after N.N.Burdenko ( Site 1608)
• Saudi Arabia
  • Al Bahah Region
    • Mecca, Al Bahah Region, Saudi Arabia, 24211
      • Hera General Hospital ( Site 1725)
  • Makkah Al Mukarramah
    • Jeddah, Makkah Al Mukarramah, Saudi Arabia, 21423
      • King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)
  • Riyadh Region
    • Al Ahsa, Riyadh Region, Saudi Arabia, 31982
      • King Abdulaziz Medical City - Al Ahsa ( Site 1730)
    • Riyadh, Riyadh Region, Saudi Arabia, 11426
      • King Abdul Aziz Medical City - AlRiyadh ( Site 1700)
    • Riyadh, Riyadh Region, Saudi Arabia, 11426
      • King Abdul Aziz Medical City - AlRiyadh ( Site 1705)
    • Riyadh, Riyadh Region, Saudi Arabia, 11564
      • King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)
    • Riyadh, Riyadh Region, Saudi Arabia, 11564
      • King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01330
    • Cukurova Uni. Tip Fakultesi ( Site 2403)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407)
  • Istanbul, Turkey (Türkiye), 34854
    • Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34098
      • I. U. Cerrahpasa Tip Fakultesi ( Site 2406)
• Ukraine
  • Chernivetska Oblast
    • Chernivtsi, Chernivetska Oblast, Ukraine, 58002
      • Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (
  • Dnipropetrovsk Oblast
    • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49100
      • SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)
  • Kharkivs’ka Oblast’
    • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61093
      • MHI Regional Childrens Clinical Hospital ( Site 1908)
    • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61153
      • Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915)
  • Kyivska Oblast
    • Kyiv, Kyivska Oblast, Ukraine, 01021
      • Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)
    • Kyiv, Kyivska Oblast, Ukraine, 03039
      • Medical Center Verum ( Site 1913)
    • Kyiv, Kyivska Oblast, Ukraine, 04114
      • Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)
  • Odesa Oblast
    • Odesa, Odesa Oblast, Ukraine, 65031
      • Odessa Regional Children Clinical Hospital ( Site 1912)
  • Vinnytsia Oblast
    • Vinnytsia, Vinnytsia Oblast, Ukraine, 21010
      • Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)
• United Arab Emirates
  • Ajman, United Arab Emirates, 4184
    • Thumbay University Hospital ( Site 2001)
  • Ajman, United Arab Emirates, 5166
    • Rashid Center For Diabetes and Research ( Site 2006)
  • Dubayy
    • Dubai, Dubayy, United Arab Emirates, 215252
      • Dubai Diabetes Center ( Site 2002)
    • Dubai, Dubayy, United Arab Emirates, 445498
      • Mustafa Al Qaysi Medical Centre ( Site 2010)
    • Dubai, Dubayy, United Arab Emirates, 505004
      • Mediclinic City Hospital ( Site 2005)
    • Dubai, Dubayy, United Arab Emirates, 7662
      • Al Jalila Children s Specialty Hospital ( Site 2004)
• United Kingdom
  • London, City of
    • London, London, City of, United Kingdom, E1 1FR
      • Royal London Hospital (Whitechapel) ( Site 2100)
    • London, London, City of, United Kingdom, SW10 9NH
      • Chelsea and Westminster Hospital ( Site 2103)
    • London, London, City of, United Kingdom, TW7 6AF
      • West Middlesex University Hospital ( Site 2104)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1711
      • The University of Alabama at Birmingham ( Site 2207)
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital - Los Angeles ( Site 2201)
    • Sacramento, California, United States, 95821
      • Center of Excellence in Diabetes and Endocrinology ( Site 2203)
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si
  • Illinois
    • Chicago, Illinois, United States, 60659
      • ICCT Research International, Inc. ( Site 2211)
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Barry J. Reiner MD LLC ( Site 2204)
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital ( Site 2219)
  • New York
    • The Bronx, New York, United States, 10455
      • CHEAR Center LLC ( Site 2200)
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • Coastal Children''s Services ( Site 2202)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia ( Site 2205)
  • Texas
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology and Associates PA ( Site 2218)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• Be ≥10 years and ≤17 years of age, when the informed consent is signed
• 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 history of 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 at Screening.
• On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, OR on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and a stable dose of insulin for ≥8 weeks prior to Screening.
• Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Is a non-sterilized female who is currently not sexually active OR who agrees to abstain from heterosexual activity OR who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.
• Has known monogenic diabetes, or secondary diabetes.
• Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation 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 the study, 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ertugliflozin 5 mg; All participants initially received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.	Drug: Ertugliflozin 5 mg; Ertugliflozin 5 mg, oral, 1 tablet QD; Other Names: MK-8835; PF-04971729; Drug: Placebo to ertugliflozin 15 mg; Placebo to ertugliflozin 15 mg, oral, 1 tablet QD; Biological: Insulin; Participants on insulin at screening continued to receive a stable dose of background insulin. The initiation and titration of insulin for rescue therapy was at the discretion of the investigator, based on local/regional/country guidelines.; Drug: Metformin; Participants received stable dose of background metformin.
Experimental: Ertugliflozin 5 mg/5 mg; All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.	Drug: Ertugliflozin 5 mg; Ertugliflozin 5 mg, oral, 1 tablet QD; Other Names: MK-8835; PF-04971729; Drug: Placebo to ertugliflozin 15 mg; Placebo to ertugliflozin 15 mg, oral, 1 tablet QD; Biological: Insulin; Participants on insulin at screening continued to receive a stable dose of background insulin. The initiation and titration of insulin for rescue therapy was at the discretion of the investigator, based on local/regional/country guidelines.; Drug: Metformin; Participants received stable dose of background metformin.
Experimental: Ertugliflozin 5 mg/15 mg; All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were up-titrated to 15 mg ERTU and placebo to 5 mg ERTU from WK12 to WK54.	Drug: Ertugliflozin 5 mg; Ertugliflozin 5 mg, oral, 1 tablet QD; Other Names: MK-8835; PF-04971729; Drug: Ertugliflozin 15 mg; Ertugliflozin 15 mg, oral, 1 tablet QD; Other Names: MK-8835; PF-04971729; Drug: Placebo to ertugliflozin 15 mg; Placebo to ertugliflozin 15 mg, oral, 1 tablet QD; Drug: Placebo to ertugliflozin 5 mg; Placebo to ertugliflozin 5 mg, oral, 1 tablet QD; Biological: Insulin; Participants on insulin at screening continued to receive a stable dose of background insulin. The initiation and titration of insulin for rescue therapy was at the discretion of the investigator, based on local/regional/country guidelines.; Drug: Metformin; Participants received stable dose of background metformin.
Placebo Comparator: Placebo; All participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.	Drug: Placebo to ertugliflozin 15 mg; Placebo to ertugliflozin 15 mg, oral, 1 tablet QD; Drug: Placebo to ertugliflozin 5 mg; Placebo to ertugliflozin 5 mg, oral, 1 tablet QD; Biological: Insulin; Participants on insulin at screening continued to receive a stable dose of background insulin. The initiation and titration of insulin for rescue therapy was at the discretion of the investigator, based on local/regional/country guidelines.; Drug: Metformin; Participants received stable dose of background metformin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)	Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The Bayesian mean change from baseline for each combined ertugliflozin and placebo are reported. Per protocol, the ertugliflozin arms are combined for this analysis.	Baseline and Week 24
Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24	An adverse event -- Select --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. Per protocol, the ertugliflozin arms are combined for this analysis.	Up to Week 24
Number of Participants Who Experienced an AE Up to Week 54	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. Per protocol, the ertugliflozin arms are combined for this analysis.	Up to Week 54
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24	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. Per protocol, the ertugliflozin arms are combined for this analysis.	Up to Week 24
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 54	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. Per protocol, the ertugliflozin arms are combined for this analysis.	Up to Week 54

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.	Baseline and Week 24
Change From Baseline in Hemoglobin A1C at Week 24 (5 mg Ertugliflozin Versus Placebo)	Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.	Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood was 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). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.	Baseline and Week 24
Change From Baseline in Hemoglobin A1C at Week 54	Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 54 to determine the A1C change from baseline (i.e., A1C at Week 54 minus A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.	Baseline and Week 54
Change From Baseline in FPG at Week 54	Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood was 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). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.	Baseline and Week 54

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: Pfizer
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): April 11, 2025
• Study Completion (Actual): April 11, 2025

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Organic Chemicals; Biguanides; Guanidines; Amidines; Insulins; Pancreatic Hormones; Proinsulin; Metformin; Insulin; ertugliflozin
• Other Study ID Numbers: 8835-059; PHRR190913-002184 (Registry Identifier: PHRR); 2022-501085-21-00 (Registry Identifier: EU CT); 2017-003455-35 (EudraCT Number); U1111-1279-3984 (Registry Identifier: UTN); MK-8835-059 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No