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Type 2 Diabetes MellitusPhase 3NCT04029480

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

A Phase 3 study testing Ertugliflozin 5 mg, Ertugliflozin 15 mg and Insulin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC at 104 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Ertugliflozin 5 mg, Ertugliflozin 15 mg and Insulin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
104 sitesin 22 countries
Study dates
8 Oct 2019to 11 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

104 sites in 22 countries.

104 sites in 22 countries

United States11 sites

  • Barry J. Reiner MD LLC ( Site 2204)

    Baltimore, Maryland, 21229

  • The University of Alabama at Birmingham ( Site 2207)

    Birmingham, Alabama, 35233-1711

  • ICCT Research International, Inc. ( Site 2211)

    Chicago, Illinois, 60659

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

    Hollywood, Florida, 33021

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

    Los Angeles, California, 90027

  • Southern Endocrinology and Associates PA ( Site 2218)

    Mesquite, Texas, 75149

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

    Philadelphia, Pennsylvania, 19104

  • William Beaumont Hospital ( Site 2219)

    Royal Oak, Michigan, 48073

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

    Sacramento, California, 95821

  • CHEAR Center LLC ( Site 2200)

    The Bronx, New York, 10455

  • Coastal Children''s Services ( Site 2202)

    Wilmington, North Carolina, 28403

Other trials in United States

Mexico10 sites

  • Centro de Investigacion Medica Aguascalientes ( Site 1000)

    Aguascalientes, 20116

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

    Aguascalientes, 20119

  • Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)

    Culiacán, Sinaloa, 80000

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

    Guadalajara, Jalisco, 44150

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

    Guadalajara, Jalisco, 44260

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

    Madero, Tamaulipas, 89440

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

    Mexico City, Mexico City, 06760

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

    Mexico City, Mexico City, 11410

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

    Monterrey, Nuevo León, 64460

  • Unidad de Medicina Especializada SMA ( Site 1004)

    San Juan del Río, Querétaro, 76800

Other trials in Mexico

Russia9 sites

  • Kazan State Medical University ( Site 1601)

    Kazan', Tatarstan, Respublika, 420029

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

    Moscow, Moscow, 117036

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

    Novosibirsk, Novosibirsk Oblast, 630048

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

    Rostov-on-Don, Rostov Oblast, 344012

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

    Saint Petersburg, Sankt-Peterburg, 194100

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

    Samara, Samara Oblast, 443079

  • Siberian State Medical University ( Site 1602)

    Tomsk, Tomsk Oblast, 634050

  • Bashkir State Medical University Hospital ( Site 1603)

    Ufa, Baskortostan, Respublika, 450083

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

    Voronezh, Voronezskaja Oblast, 394024

Other trials in Russia

Ukraine9 sites

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

    Chernivtsi, Chernivetska Oblast, 58002

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

    Dnipro, Dnipropetrovsk Oblast, 49100

  • MHI Regional Childrens Clinical Hospital ( Site 1908)

    Kharkiv, Kharkiv Oblast, 61093

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

    Kharkiv, Kharkiv Oblast, 61153

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

    Kyiv, Kyivska Oblast, 01021

  • Medical Center Verum ( Site 1913)

    Kyiv, Kyivska Oblast, 03039

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

    Kyiv, Kyivska Oblast, 04114

  • Odessa Regional Children Clinical Hospital ( Site 1912)

    Odesa, Odesa Oblast, 65031

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

    Vinnytsia, Vinnytsia Oblast, 21010

Other trials in Ukraine

Hungary8 sites

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

    Békéscsaba, Bekescsaba, 5600

  • Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)

    Budapest, 1089

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

    Budapest, 1094

  • Petz Aladar Megyei Oktato Korhaz ( Site 0709)

    Győr, Győr-Moson-Sopron, 9023

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

    Miskolc, Borsod-Abauj Zemplen county, 3526

  • Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 0704)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)

    Pécs, Baranya, 7623

  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)

    Székesfehérvár, Fejér, 8000

Other trials in Hungary

Saudi Arabia7 sites

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

    Al Ahsa, Riyadh Region, 31982

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

    Jeddah, Makkah Al Mukarramah, 21423

  • Hera General Hospital ( Site 1725)

    Mecca, Al Bahah Region, 24211

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

    Riyadh, Riyadh Region, 11426

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

    Riyadh, Riyadh Region, 11426

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

    Riyadh, Riyadh Region, 11564

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

    Riyadh, Riyadh Region, 11564

Other trials in Saudi Arabia

Italy6 sites

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

    Caltanissetta, 93100

  • A.O.Universitaria Meyer ( Site 0901)

    Florence, Tuscany, 50139

  • IRCCS G. Gaslini ( Site 0900)

    Genova, 16147

  • AOU Federico II di Napoli ( Site 0902)

    Naples, 80123

  • IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)

    Roma, 00165

  • Ospedale Regina Margherita ( Site 0905)

    Torino, 10126

Other trials in Italy

United Arab Emirates6 sites

  • Thumbay University Hospital ( Site 2001)

    Ajman, 4184

  • Rashid Center For Diabetes and Research ( Site 2006)

    Ajman, 5166

  • Dubai Diabetes Center ( Site 2002)

    Dubai, Dubayy, 215252

  • Mustafa Al Qaysi Medical Centre ( Site 2010)

    Dubai, Dubayy, 445498

  • Mediclinic City Hospital ( Site 2005)

    Dubai, Dubayy, 505004

  • Al Jalila Children s Specialty Hospital ( Site 2004)

    Dubai, Dubayy, 7662

Other trials in United Arab Emirates

Israel5 sites

  • Soroka University Medical Center ( Site 0802)

    Beersheba, 8410101

  • Armon M.C ( Site 0803)

    Haifa, 3350121

  • Rambam Medical Center ( Site 0801)

    Haifa, 3525408

  • Hadassah Mount Scopus ( Site 0800)

    Jerusalem, 9124001

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

    Ramat Gan, 5265601

Other trials in Israel

Malaysia5 sites

  • Hospital Pulau Pinang. ( Site 1101)

    George Town, Pulau Pinang, 10990

  • University Malaya Medical Centre ( Site 1100)

    Kuala Lumpur, 59100

  • Hospital Universiti Sains Malaysia ( Site 1102)

    Kubang Kerian, Kelantan, 16150

  • Hospital Putrajaya ( Site 1103)

    Putrajaya, Putrajaya, 62000

  • Hospital Taiping ( Site 1104)

    Taiping, Perak, 34000

Other trials in Malaysia

Poland4 sites

  • IN VIVO ( Site 1501)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-046

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

    Katowice, Silesian Voivodeship, 40-156

  • Instytut Diabetologii Sp z o o ( Site 1512)

    Warsaw, Masovian Voivodeship, 02-117

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

    Wierzchosławice, Lesser Poland Voivodeship, 33-122

Other trials in Poland

Turkey (Türkiye)4 sites

  • Cukurova Uni. Tip Fakultesi ( Site 2403)

    Adana, 01330

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

    Ankara, 06800

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

    Istanbul, Istanbul, 34098

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

    Istanbul, 34854

Other trials in Turkey (Türkiye)

Guatemala3 sites

  • Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)

    Chiquimula, 20001

  • Endopedia ( Site 0503)

    Guatemala City, 01009

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

    Guatemala City, 01014

Other trials in Guatemala

Philippines3 sites

  • Davao Doctors Hospital ( Site 1400)

    Davao City, Davao Del Sur, 8000

  • West Visayas State University Medical Center ( Site 1401)

    Iloilo City, 5000

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

    Marikina City, National Capital Region, 1810

Other trials in Philippines

United Kingdom3 sites

  • Royal London Hospital (Whitechapel) ( Site 2100)

    London, London, City of, E1 1FR

  • Chelsea and Westminster Hospital ( Site 2103)

    London, London, City of, SW10 9NH

  • West Middlesex University Hospital ( Site 2104)

    London, London, City of, TW7 6AF

Other trials in United Kingdom

Canada2 sites

  • London Health Sciences Centre ( Site 0002)

    London, Ontario, N6A 5W9

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

    Montreal, Quebec, H1T 2M4

Other trials in Canada

Colombia2 sites

  • Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)

    Barranquilla, Atlántico, 080020

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

    Bogotá, Bogota D.C., 110221

Other trials in Colombia

France2 sites

  • CHU Amiens Hopital Sud ( Site 0413)

    Amiens, Picardie, 80054

  • CHU du BOCAGE ( Site 0407)

    Dijon, Cote-d Or, 21079

Other trials in France

Mauritius2 sites

  • Life Nova+ ( Site 1203)

    Forbach, Pamplemousses District, 21014

  • Wellkin Hospital ( Site 1200)

    Moka, 80812

Other trials in Mauritius

Belgium1 site

  • Cliniques Universitaires Saint-Luc ( Site 2300)

    Brussels, Bruxelles-Capitale, Region de, 1200

Other trials in Belgium

Costa Rica1 site

  • Clinica Los Yoses ( Site 0200)

    San José, 11501

Other trials in Costa Rica

Dominican Republic1 site

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

    Santo Domingo, Nacional, 10101

Other trials in Dominican Republic

About this study

Official title: 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.

Read the 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.

Being tested
Ertugliflozin 5 mg, Ertugliflozin 15 mg, Placebo to ertugliflozin 15 mg, Placebo to ertugliflozin 5 mg, Insulin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ertugliflozin 5 mgDrug

    Also called MK-8835, PF-04971729

    Ertugliflozin 5 mg, oral, 1 tablet QD

  • Ertugliflozin 15 mgDrug

    Also called MK-8835, PF-04971729

    Ertugliflozin 15 mg, oral, 1 tablet QD

  • Placebo to ertugliflozin 15 mgDrug

    Placebo to ertugliflozin 15 mg, oral, 1 tablet QD

  • Placebo to ertugliflozin 5 mgDrug

    Placebo to ertugliflozin 5 mg, oral, 1 tablet QD

  • InsulinBiological

    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.

  • MetforminDrug

    Participants received stable dose of background metformin.

Study groups in NCT04029480
Study groupRoleWhat they receive
Ertugliflozin 5 mgExperimentalAll 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.
Receives: Drug: Ertugliflozin 5 mg; Drug: Placebo to ertugliflozin 15 mg; Biological: Insulin; Drug: Metformin
Ertugliflozin 5 mg/5 mgExperimentalAll 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.
Receives: Drug: Ertugliflozin 5 mg; Drug: Placebo to ertugliflozin 15 mg; Biological: Insulin; Drug: Metformin
Ertugliflozin 5 mg/15 mgExperimentalAll 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.
Receives: Drug: Ertugliflozin 5 mg; Drug: Ertugliflozin 15 mg; Drug: Placebo to ertugliflozin 15 mg; Drug: Placebo to ertugliflozin 5 mg; Biological: Insulin; Drug: Metformin
PlaceboPlacebo comparatorAll 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.
Receives: Drug: Placebo to ertugliflozin 15 mg; Drug: Placebo to ertugliflozin 5 mg; Biological: Insulin; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 24

  2. 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.

    Measured: Up to Week 24

  3. 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.

    Measured: Up to Week 54

  4. 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.

    Measured: Up to Week 24

  5. 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.

    Measured: Up to Week 54

Secondary outcomes (5)

  1. 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.

    Measured: Baseline and Week 24

  2. 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.

    Measured: Baseline and Week 24

  3. 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.

    Measured: Baseline and Week 24

  4. 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.

    Measured: Baseline and Week 54

  5. 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.

    Measured: Baseline and Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2019
  2. Study start8 Oct 2019
  3. Primary completion11 Apr 2025
  4. Study completion11 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04029480
Sponsor's protocol ID
8835-059
Other IDs
PHRR190913-002184, 2022-501085-21-00, U1111-1279-3984, MK-8835-059, 2017-003455-35, 2017
Status last verified
Oct 2025
First submitted
11 Jul 2019
Last updated
31 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ertugliflozin 5 mg, Ertugliflozin 15 mg and Insulin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC at 104 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Mexico, Russia, Ukraine, Hungary and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo) (time frame: Baseline and Week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04029480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.

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