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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ertugliflozin 5 mg
Ertugliflozin 15 mg
Placebo to ertugliflozin 15 mg
Placebo to ertugliflozin 5 mg
Insulin
Metformin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
  2. Has body mass index (BMI) ≥85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
  3. T2DM for ≥2 years, OR T2DM for <2 years and a fasting C-peptide value >0.6 ng/mL at Screening.
  4. 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.
  5. Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  6. Is a non-sterilized female who is currently not sexually active OR who agrees 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.
  7. 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:

  1. Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.
  2. Has known monogenic diabetes, or secondary diabetes.
  3. Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin.
  4. Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
  5. Is pregnant, or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study medication.
  6. Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
  7. Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
  8. Has a history of severe hypoglycemia while on insulin.

Sites / Locations

  • The University of Alabama at Birmingham ( Site 2207)
  • Children's Hospital - Los Angeles ( Site 2201)Recruiting
  • Center of Excellence in Diabetes and Endocrinology ( Site 2203)
  • Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si
  • ICCT Research International, Inc. ( Site 2211)
  • Barry J. Reiner MD LLC ( Site 2204)Recruiting
  • William Beaumont Hospital ( Site 2219)Recruiting
  • CHEAR Center LLC ( Site 2200)
  • Coastal Children''s Services ( Site 2202)
  • The Children's Hospital of Philadelphia ( Site 2205)Recruiting
  • Southern Endocrinology and Associates PA ( Site 2218)
  • Cliniques Universitaires Saint-Luc ( Site 2300)
  • London Health Sciences Centre ( Site 0002)
  • Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)
  • Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)
  • MedPlus Medicina Prepagada S.A. ( Site 0102)
  • Clinica Los Yoses ( Site 0200)Recruiting
  • Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)Recruiting
  • CHU du BOCAGE ( Site 0407)
  • CHU Amiens Hopital Sud ( Site 0413)
  • Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)
  • Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502)Recruiting
  • Endopedia ( Site 0503)Recruiting
  • Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)Recruiting
  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705)Recruiting
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)Recruiting
  • Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)Recruiting
  • Petz Aladar Megyei Oktato Korhaz ( Site 0709)Recruiting
  • Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktato korhaz ( Site 0704)Recruiting
  • Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)Recruiting
  • Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)Recruiting
  • Soroka University Medical Center ( Site 0802)Recruiting
  • Armon M.C ( Site 0803)Recruiting
  • Rambam Medical Center ( Site 0801)Recruiting
  • Hadassah Mount Scopus ( Site 0800)Recruiting
  • The Edmond and Lily Safra Children s Hospital ( Site 0804)Recruiting
  • A.O.Universitaria Meyer ( Site 0901)Recruiting
  • U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904)Recruiting
  • IRCCS G. Gaslini ( Site 0900)Recruiting
  • AOU Federico II di Napoli ( Site 0902)Recruiting
  • IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)Recruiting
  • Hospital Universiti Sains Malaysia ( Site 1102)Recruiting
  • Hospital Taiping ( Site 1104)Recruiting
  • Hospital Pulau Pinang. ( Site 1101)Recruiting
  • Hospital Putrajaya ( Site 1103)Recruiting
  • University Malaya Medical Centre ( Site 1100)Recruiting
  • Wellkin Hospital ( Site 1200)Recruiting
  • Bio Investigación AMARC, S.C. ( Site 1006)Recruiting
  • CAIMED Investigación en Salud S.A de C.V ( Site 1008)Recruiting
  • Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)Recruiting
  • Centro de Investigacion Medica de Occidente S.C. ( Site 1001)Recruiting
  • Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)Recruiting
  • Unidad de Medicina Especializada SMA ( Site 1004)Recruiting
  • Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)Recruiting
  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)Recruiting
  • Centro de Investigacion Medica Aguascalientes ( Site 1000)Recruiting
  • Centro de Atencion e Investigacion Clinica SC ( Site 1009)Recruiting
  • Davao Doctors Hospital ( Site 1400)Recruiting
  • Institute for Studies on Diabetes Foundation Inc. ( Site 1402)Recruiting
  • West Visayas State University Medical Center ( Site 1401)Recruiting
  • IN VIVO ( Site 1501)
  • Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)
  • Instytut Diabetologii Sp z o o ( Site 1512)
  • Clinical Medical Research Sp. z o.o. ( Site 1511)
  • Bashkir State Medical University Hospital ( Site 1603)
  • Federal State Budget Institution Endocrinological Research Center ( Site 1611)
  • Children's City Clinical Hospital #1 ( Site 1604)
  • Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)
  • Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)
  • St.Petersburg State Pediatric Medical University ( Site 1600)
  • Kazan State Medical University ( Site 1601)
  • Siberian State Medical University ( Site 1602)
  • Voronezh State Medical University named after N.N.Burdenko ( Site 1608)
  • Hera General Hospital ( Site 1725)Recruiting
  • King Abdulaziz Medical City - Al Ahsa ( Site 1730)Recruiting
  • King Abdul Aziz Medical City - AlRiyadh ( Site 1700)Recruiting
  • King Abdul Aziz Medical City - AlRiyadh ( Site 1705)Recruiting
  • King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)Recruiting
  • King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)Recruiting
  • King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)Recruiting
  • I. U. Cerrahpasa Tip Fakultesi ( Site 2406)Recruiting
  • Cukurova Uni. Tip Fakultesi ( Site 2403)Recruiting
  • Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407)Recruiting
  • Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400)Recruiting
  • Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (
  • SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)
  • MHI Regional Childrens Clinical Hospital ( Site 1908)
  • Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915)
  • Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)
  • Medical Center Verum ( Site 1913)
  • Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)
  • Odessa Regional Children Clinical Hospital ( Site 1912)
  • Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)
  • Dubai Diabetes Center ( Site 2002)
  • Mustafa Al Qaysi Medical Centre ( Site 2010)Recruiting
  • Mediclinic City Hospital ( Site 2005)
  • Al Jalila Children s Specialty Hospital ( Site 2004)Recruiting
  • Thumbay University Hospital ( Site 2001)Recruiting
  • Rashid Center For Diabetes and Research ( Site 2006)Recruiting
  • Royal London Hospital (Whitechapel) ( Site 2100)
  • Chelsea and Westminster Hospital ( Site 2103)
  • West Middlesex University Hospital ( Site 2104)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ertugliflozin 5 mg/5 mg

Ertugliflozin 5 mg/15 mg

Placebo

Arm Description

All participants will initially receive ertugliflozin (ERTU) 5 mg once daily (QD) and placebo to ERTU 15 mg QD for 12 weeks. At the second randomization at Week 12 (WK12), all participants that do not meet the up-titration criteria will remain on ERTU 5 mg and placebo to ERTU 15 mg from WK12 to WK54. Approximately half the participants who meet the up-titration criteria at the second randomization at WK12 will also remain on ERTU 5 mg and placebo to ERTU 15 mg from WK12 to WK54. Note: For participants not on insulin, the up-titration criterion at the second randomization at WK12 is HbA1C ≥7.0% (53 mmol/mol) and for participants on insulin, a fasting fingerstick glucose (FFSG) of ≥110 mg/dL (6.1 mmol/L) will be required in addition to HbA1C ≥7.0% (53 mmol/mol). Participants will remain on their background metformin with/without insulin treatment throughout the study.

All participants will initially receive ERTU 5 mg QD and placebo to ERTU 15 mg QD for 12 weeks. At the second randomization at WK12, approximately half the participants who meet the up-titration criteria at the second randomization will up-titrate to ERTU 15 mg and placebo to ERTU 5 mg from WK12 to WK54. Note: For participants not on insulin, the up-titration criterion at the second randomization at WK12 is HbA1C ≥7.0% (53 mmol/mol) and for participants on insulin, a FFSG of ≥110 mg/dL (6.1 mmol/L) will be required in addition to HbA1C ≥7.0% (53 mmol/mol). Participants will remain on their background metformin with/without insulin treatment throughout the study.

At the first randomization, participants receive placebo to ERTU 5 mg and placebo to ERTU 15 mg QD for 12 weeks. Participants in the placebo group with HbA1C ≥7.0% (53 mmol/mol) at WK12 will be mock titrated. Note: The up-titration criteria for participants on insulin will include a FFSG of ≥110 mg/dL (6.1 mmol/L) in addition to HbA1C ≥7.0% (53 mmol/mol) at WK12. Participants will continue to receive placebo to ERTU 5 mg and placebo to ERTU 15 mg QD from WK24 to WK54. Participants will remain on their background metformin with/without insulin treatment throughout the study.

Outcomes

Primary Outcome Measures

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).
Number of Participants Who Experience an Adverse Event (AE)
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.
Number of Participants Who Experience an AE
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.
Number of Participants Who Discontinue Study Treatment Due to an AE
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.
Number of Participants Who Discontinue Study Treatment Due to an AE
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.

Secondary Outcome Measures

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).
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).
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).
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).
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).

Full Information

First Posted
July 11, 2019
Last Updated
October 12, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04029480
Brief Title
Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
July 10, 2025 (Anticipated)
Study Completion Date
July 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ertugliflozin 5 mg/5 mg
Arm Type
Experimental
Arm Description
All participants will initially receive ertugliflozin (ERTU) 5 mg once daily (QD) and placebo to ERTU 15 mg QD for 12 weeks. At the second randomization at Week 12 (WK12), all participants that do not meet the up-titration criteria will remain on ERTU 5 mg and placebo to ERTU 15 mg from WK12 to WK54. Approximately half the participants who meet the up-titration criteria at the second randomization at WK12 will also remain on ERTU 5 mg and placebo to ERTU 15 mg from WK12 to WK54. Note: For participants not on insulin, the up-titration criterion at the second randomization at WK12 is HbA1C ≥7.0% (53 mmol/mol) and for participants on insulin, a fasting fingerstick glucose (FFSG) of ≥110 mg/dL (6.1 mmol/L) will be required in addition to HbA1C ≥7.0% (53 mmol/mol). Participants will remain on their background metformin with/without insulin treatment throughout the study.
Arm Title
Ertugliflozin 5 mg/15 mg
Arm Type
Experimental
Arm Description
All participants will initially receive ERTU 5 mg QD and placebo to ERTU 15 mg QD for 12 weeks. At the second randomization at WK12, approximately half the participants who meet the up-titration criteria at the second randomization will up-titrate to ERTU 15 mg and placebo to ERTU 5 mg from WK12 to WK54. Note: For participants not on insulin, the up-titration criterion at the second randomization at WK12 is HbA1C ≥7.0% (53 mmol/mol) and for participants on insulin, a FFSG of ≥110 mg/dL (6.1 mmol/L) will be required in addition to HbA1C ≥7.0% (53 mmol/mol). Participants will remain on their background metformin with/without insulin treatment throughout the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
At the first randomization, participants receive placebo to ERTU 5 mg and placebo to ERTU 15 mg QD for 12 weeks. Participants in the placebo group with HbA1C ≥7.0% (53 mmol/mol) at WK12 will be mock titrated. Note: The up-titration criteria for participants on insulin will include a FFSG of ≥110 mg/dL (6.1 mmol/L) in addition to HbA1C ≥7.0% (53 mmol/mol) at WK12. Participants will continue to receive placebo to ERTU 5 mg and placebo to ERTU 15 mg QD from WK24 to WK54. Participants will remain on their background metformin with/without insulin treatment throughout the study.
Intervention Type
Drug
Intervention Name(s)
Ertugliflozin 5 mg
Other Intervention Name(s)
MK-8835
Intervention Description
Ertugliflozin 5 mg, oral, 1 tablet QD
Intervention Type
Drug
Intervention Name(s)
Ertugliflozin 15 mg
Other Intervention Name(s)
MK-8835
Intervention Description
Ertugliflozin 15 mg, oral, 1 tablet QD
Intervention Type
Drug
Intervention Name(s)
Placebo to ertugliflozin 15 mg
Intervention Description
Placebo to ertugliflozin 15 mg, oral, 1 tablet QD
Intervention Type
Drug
Intervention Name(s)
Placebo to ertugliflozin 5 mg
Intervention Description
Placebo to ertugliflozin 5 mg, oral, 1 tablet QD
Intervention Type
Biological
Intervention Name(s)
Insulin
Intervention Description
The initiation and titration of insulin will be at the discretion of the investigator, based on local/regional/country guidelines.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Participants will receive stable dose of background metformin.
Primary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin 5 mg and 15 mg versus placebo)
Description
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).
Time Frame
Baseline and 24 weeks
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
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.
Time Frame
Up to 24 weeks
Title
Number of Participants Who Experience an AE
Description
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.
Time Frame
Up to 54 weeks
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
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.
Time Frame
Up to 24 weeks
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
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.
Time Frame
Up to 54 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1C at Week 24 (dose-optimized ertugliflozin versus placebo)
Description
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).
Time Frame
Baseline and 24 weeks
Title
Change from Baseline in Hemoglobin A1C at Week 24 (ertugliflozin 5 mg versus placebo)
Description
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).
Time Frame
Baseline and 24 weeks
Title
Change from Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks
Description
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).
Time Frame
Baseline and 24 weeks
Title
Change from Baseline in Hemoglobin A1C at 54 Weeks
Description
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).
Time Frame
Baseline and 54 weeks
Title
Change from Baseline in FPG at 54 Weeks
Description
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).
Time Frame
Baseline and 54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham ( Site 2207)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1711
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital - Los Angeles ( Site 2201)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
323-361-6327
Facility Name
Center of Excellence in Diabetes and Endocrinology ( Site 2203)
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Completed
Facility Name
Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Completed
Facility Name
ICCT Research International, Inc. ( Site 2211)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60659
Country
United States
Individual Site Status
Completed
Facility Name
Barry J. Reiner MD LLC ( Site 2204)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
410-646-4009
Facility Name
William Beaumont Hospital ( Site 2219)
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
248-898-4578
Facility Name
CHEAR Center LLC ( Site 2200)
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Individual Site Status
Completed
Facility Name
Coastal Children''s Services ( Site 2202)
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Individual Site Status
Completed
Facility Name
The Children's Hospital of Philadelphia ( Site 2205)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
267-426-9218
Facility Name
Southern Endocrinology and Associates PA ( Site 2218)
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Completed
Facility Name
Cliniques Universitaires Saint-Luc ( Site 2300)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Completed
Facility Name
London Health Sciences Centre ( Site 0002)
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Completed
Facility Name
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Completed
Facility Name
Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Completed
Facility Name
MedPlus Medicina Prepagada S.A. ( Site 0102)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Completed
Facility Name
Clinica Los Yoses ( Site 0200)
City
San Jose
ZIP/Postal Code
11501
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50622536440
Facility Name
Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)
City
Santo Domingo
State/Province
Distrito Nacional
ZIP/Postal Code
10101
Country
Dominican Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8299124020
Facility Name
CHU du BOCAGE ( Site 0407)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21079
Country
France
Individual Site Status
Completed
Facility Name
CHU Amiens Hopital Sud ( Site 0413)
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Completed
Facility Name
Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)
City
Chiquimula
ZIP/Postal Code
20001
Country
Guatemala
Individual Site Status
Completed
Facility Name
Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502)
City
Guatemala City
ZIP/Postal Code
01014
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50240347015
Facility Name
Endopedia ( Site 0503)
City
Guatemala
ZIP/Postal Code
01009
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50253166777
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7623
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3672535900
Facility Name
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705)
City
Békéscsaba
State/Province
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3666526526
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3646515200
Facility Name
Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)
City
Székesfehérvár
State/Province
Fejer
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36208236401
Facility Name
Petz Aladar Megyei Oktato Korhaz ( Site 0709)
City
Gyor
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
9023
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3696507948
Facility Name
Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktato korhaz ( Site 0704)
City
Nyiregyhaza
State/Province
Szabolcs-Szatmar-Bereg
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3642599800 ext 1767
Facility Name
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3614599100 ext 1218
Facility Name
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3612151380
Facility Name
Soroka University Medical Center ( Site 0802)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97286403158
Facility Name
Armon M.C ( Site 0803)
City
Haifa
ZIP/Postal Code
3350121
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972507483453
Facility Name
Rambam Medical Center ( Site 0801)
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97247771606
Facility Name
Hadassah Mount Scopus ( Site 0800)
City
Jerusalem
ZIP/Postal Code
9124001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97225844430
Facility Name
The Edmond and Lily Safra Children s Hospital ( Site 0804)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+97235305015
Facility Name
A.O.Universitaria Meyer ( Site 0901)
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390555662486
Facility Name
U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904)
City
Caltanissetta
ZIP/Postal Code
93100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+393473478353
Facility Name
IRCCS G. Gaslini ( Site 0900)
City
Genova
ZIP/Postal Code
16147
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+393474038247
Facility Name
AOU Federico II di Napoli ( Site 0902)
City
Napoli
ZIP/Postal Code
80123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390817464234
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)
City
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390668593074
Facility Name
Hospital Universiti Sains Malaysia ( Site 1102)
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6097673748
Facility Name
Hospital Taiping ( Site 1104)
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6058204029
Facility Name
Hospital Pulau Pinang. ( Site 1101)
City
Georgetown
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6042225707
Facility Name
Hospital Putrajaya ( Site 1103)
City
Putrajaya
State/Province
Wilayah Persekutuan Putrajaya
ZIP/Postal Code
62000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+60383145472
Facility Name
University Malaya Medical Centre ( Site 1100)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+60379492065
Facility Name
Wellkin Hospital ( Site 1200)
City
Moka
ZIP/Postal Code
80812
Country
Mauritius
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+230 59111128
Facility Name
Bio Investigación AMARC, S.C. ( Site 1006)
City
Ciudad de México
State/Province
Distrito Federal
ZIP/Postal Code
11410
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+52 55 2158 3697
Facility Name
CAIMED Investigación en Salud S.A de C.V ( Site 1008)
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+525565834651
Facility Name
Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44150
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3336152650
Facility Name
Centro de Investigacion Medica de Occidente S.C. ( Site 1001)
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45116
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+523312044280
Facility Name
Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+528183186936
Facility Name
Unidad de Medicina Especializada SMA ( Site 1004)
City
San Juan del Río
State/Province
Queretaro
ZIP/Postal Code
76800
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+52 427 101 2351
Facility Name
Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+526671033001
Facility Name
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)
City
Madero
State/Province
Tamaulipas
ZIP/Postal Code
89440
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+52 833 126 0055
Facility Name
Centro de Investigacion Medica Aguascalientes ( Site 1000)
City
Aguascalientes
ZIP/Postal Code
20116
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+524499949458
Facility Name
Centro de Atencion e Investigacion Clinica SC ( Site 1009)
City
Aguascalientes
ZIP/Postal Code
20119
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+524499930007
Facility Name
Davao Doctors Hospital ( Site 1400)
City
Davao City
State/Province
Davao Del Sur
ZIP/Postal Code
8000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+63822853032
Facility Name
Institute for Studies on Diabetes Foundation Inc. ( Site 1402)
City
Marikina
State/Province
National Capital Region
ZIP/Postal Code
1810
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+639998832018
Facility Name
West Visayas State University Medical Center ( Site 1401)
City
Iloilo
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+639178476189
Facility Name
IN VIVO ( Site 1501)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-048
Country
Poland
Individual Site Status
Completed
Facility Name
Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)
City
Wierzchoslawice
State/Province
Malopolskie
ZIP/Postal Code
33-122
Country
Poland
Individual Site Status
Completed
Facility Name
Instytut Diabetologii Sp z o o ( Site 1512)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-117
Country
Poland
Individual Site Status
Completed
Facility Name
Clinical Medical Research Sp. z o.o. ( Site 1511)
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-156
Country
Poland
Individual Site Status
Completed
Facility Name
Bashkir State Medical University Hospital ( Site 1603)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450083
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Federal State Budget Institution Endocrinological Research Center ( Site 1611)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117036
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Children's City Clinical Hospital #1 ( Site 1604)
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630048
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)
City
Rostov-on-Don
State/Province
Rostovskaya Oblast
ZIP/Postal Code
344012
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443079
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
St.Petersburg State Pediatric Medical University ( Site 1600)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194100
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Kazan State Medical University ( Site 1601)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Siberian State Medical University ( Site 1602)
City
Tomsk
State/Province
Tomskaya Oblast
ZIP/Postal Code
634050
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Voronezh State Medical University named after N.N.Burdenko ( Site 1608)
City
Voronezh
State/Province
Voronezskaja Oblast
ZIP/Postal Code
394024
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hera General Hospital ( Site 1725)
City
Mecca
State/Province
Al BaHah
ZIP/Postal Code
24211
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+966555501280
Facility Name
King Abdulaziz Medical City - Al Ahsa ( Site 1730)
City
Al Ahsa
State/Province
Ar Riyad
ZIP/Postal Code
31982
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+966509369714
Facility Name
King Abdul Aziz Medical City - AlRiyadh ( Site 1700)
City
Riyadh
State/Province
Ar Riyad
ZIP/Postal Code
11426
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+966504461425
Facility Name
King Abdul Aziz Medical City - AlRiyadh ( Site 1705)
City
Riyadh
State/Province
Ar Riyad
ZIP/Postal Code
11426
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+966504256585
Facility Name
King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)
City
Riyadh
State/Province
Ar Riyad
ZIP/Postal Code
11564
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+966555832994
Facility Name
King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)
City
Riyadh
State/Province
Ar Riyad
ZIP/Postal Code
11564
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+966505415062
Facility Name
King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)
City
Jeddah
State/Province
Makkah Al Mukarramah
ZIP/Postal Code
21423
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+966505693307
Facility Name
I. U. Cerrahpasa Tip Fakultesi ( Site 2406)
City
Istambul
State/Province
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+902124143000
Facility Name
Cukurova Uni. Tip Fakultesi ( Site 2403)
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905325169131
Facility Name
Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905057077366
Facility Name
Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400)
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02166254545
Facility Name
Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (
City
Chernivtsi
State/Province
Chernivetska Oblast
ZIP/Postal Code
58002
Country
Ukraine
Individual Site Status
Completed
Facility Name
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49100
Country
Ukraine
Individual Site Status
Completed
Facility Name
MHI Regional Childrens Clinical Hospital ( Site 1908)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61093
Country
Ukraine
Individual Site Status
Completed
Facility Name
Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61153
Country
Ukraine
Individual Site Status
Completed
Facility Name
Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
01021
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Medical Center Verum ( Site 1913)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03039
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
04114
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Odessa Regional Children Clinical Hospital ( Site 1912)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65031
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)
City
Vinnytsia
State/Province
Vinnytska Oblast
ZIP/Postal Code
21010
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Dubai Diabetes Center ( Site 2002)
City
Dubai
State/Province
Dubayy
ZIP/Postal Code
215252
Country
United Arab Emirates
Individual Site Status
Completed
Facility Name
Mustafa Al Qaysi Medical Centre ( Site 2010)
City
Dubai
State/Province
Dubayy
ZIP/Postal Code
445498
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
00971507194601
Facility Name
Mediclinic City Hospital ( Site 2005)
City
Dubai
State/Province
Dubayy
ZIP/Postal Code
505004
Country
United Arab Emirates
Individual Site Status
Completed
Facility Name
Al Jalila Children s Specialty Hospital ( Site 2004)
City
Dubai
State/Province
Dubayy
ZIP/Postal Code
7662
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+971589466920
Facility Name
Thumbay University Hospital ( Site 2001)
City
Ajman
ZIP/Postal Code
4184
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+971507879619
Facility Name
Rashid Center For Diabetes and Research ( Site 2006)
City
Ajman
ZIP/Postal Code
5166
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+971501823166
Facility Name
Royal London Hospital (Whitechapel) ( Site 2100)
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Chelsea and Westminster Hospital ( Site 2103)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Completed
Facility Name
West Middlesex University Hospital ( Site 2104)
City
London
State/Province
London, City Of
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=8835-059&kw=8835-059
Description
Plain Language Summary
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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

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