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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
France2 sites
CHU Amiens Hopital Sud ( Site 0413)
Amiens, Picardie, 80054
CHU du BOCAGE ( Site 0407)
Dijon, Cote-d Or, 21079
Mauritius2 sites
Life Nova+ ( Site 1203)
Forbach, Pamplemousses District, 21014
Wellkin Hospital ( Site 1200)
Moka, 80812
Belgium1 site
Cliniques Universitaires Saint-Luc ( Site 2300)
Brussels, Bruxelles-Capitale, Region de, 1200
Dominican Republic1 site
Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)
Santo Domingo, Nacional, 10101
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.
- Conditions
- Type 2 Diabetes Mellitus
- 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 group | Role | What they receive |
|---|---|---|
| Ertugliflozin 5 mg | Experimental | 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. Receives: Drug: Ertugliflozin 5 mg; Drug: Placebo to ertugliflozin 15 mg; Biological: Insulin; Drug: Metformin |
| Ertugliflozin 5 mg/5 mg | Experimental | 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. Receives: Drug: Ertugliflozin 5 mg; Drug: Placebo to ertugliflozin 15 mg; Biological: Insulin; Drug: Metformin |
| Ertugliflozin 5 mg/15 mg | Experimental | 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. 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 |
| Placebo | Placebo comparator | 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. 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.
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
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
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
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
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)
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
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
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
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
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.
- First posted23 Jul 2019
- Study start8 Oct 2019
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf