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

Phase 3

Active, not recruiting

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Ertugliflozin 5 mg
Drug: Placebo to ertugliflozin 5 mg
Drug: Placebo to ertugliflozin 15 mg
Drug: Ertugliflozin 15 mg
Biological: Insulin
Drug: Metformin

Registration Number: NCT04029480

Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 165

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.

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Ertugliflozin 5 mg/5 mg	Ertugliflozin 5 mg	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.
Placebo	Placebo to ertugliflozin 5 mg	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.
Ertugliflozin 5 mg/5 mg	Insulin	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.
Ertugliflozin 5 mg/15 mg	Ertugliflozin 5 mg	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.
Ertugliflozin 5 mg/15 mg	Placebo to ertugliflozin 5 mg	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.
Ertugliflozin 5 mg/5 mg	Placebo to ertugliflozin 15 mg	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.
Ertugliflozin 5 mg/15 mg	Ertugliflozin 15 mg	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.
Ertugliflozin 5 mg/15 mg	Placebo to ertugliflozin 15 mg	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.
Placebo	Placebo to ertugliflozin 15 mg	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.
Ertugliflozin 5 mg/15 mg	Insulin	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.
Ertugliflozin 5 mg/5 mg	Metformin	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.
Ertugliflozin 5 mg/15 mg	Metformin	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE) over 24 weeks	Up to 24 weeks	An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Number of Participants Who Experience an AE over 54 weeks	Up to 54 weeks	An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Number of Participants Who Discontinue Study Treatment Due to an AE over 54 weeks	Up to 54 weeks	An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin 5 mg and 15 mg versus placebo)	Baseline and 24 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 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 Discontinue Study Treatment Due to an AE over 24 weeks	Up to 24 weeks	An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in FPG at 54 Weeks	Baseline and 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).
Change from Baseline in Hemoglobin A1C at Week 24 (dose-optimized ertugliflozin versus placebo)	Baseline and 24 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 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)	Baseline and 24 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 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	Baseline and 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	Baseline and 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).

Trial Locations

Locations (104): Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si
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Hollywood, Florida, United States
William Beaumont Hospital ( Site 2219)
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Royal Oak, Michigan, United States
ICCT Research International, Inc. ( Site 2211)
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Chicago, Illinois, United States
The Children's Hospital of Philadelphia ( Site 2205)
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Philadelphia, Pennsylvania, United States
Children's Hospital - Los Angeles ( Site 2201)
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Los Angeles, California, United States
Barry J. Reiner MD LLC ( Site 2204)
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Baltimore, Maryland, United States
CHEAR Center LLC ( Site 2200)
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Bronx, New York, United States
Coastal Children''s Services ( Site 2202)
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Wilmington, North Carolina, United States
Southern Endocrinology and Associates PA ( Site 2218)
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Mesquite, Texas, United States
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)
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Montreal, Quebec, Canada
CHU du BOCAGE ( Site 0407)
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Dijon, Cote-d Or, France
CHU Amiens Hopital Sud ( Site 0413)
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Amiens, Picardie, France
Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)
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Pecs, Baranya, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)
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Miskolc, Borsod-Abauj-Zemplen, Hungary
Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)
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Székesfehérvár, Fejer, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0709)
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Gyor, Gyor-Moson-Sopron, Hungary
Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)
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Budapest, Hungary
The Edmond and Lily Safra Children s Hospital ( Site 0804)
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Ramat Gan, Israel
U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904)
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Caltanissetta, Italy
Hadassah Mount Scopus ( Site 0800)
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Jerusalem, Israel
A.O.Universitaria Meyer ( Site 0901)
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Firenze, Toscana, Italy
IRCCS G. Gaslini ( Site 0900)
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Genova, Italy
AOU Federico II di Napoli ( Site 0902)
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Napoli, Italy
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)
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Roma, Italy
Ospedale Regina Margherita ( Site 0905)
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Torino, Italy
Hospital Universiti Sains Malaysia ( Site 1102)
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Kubang Kerian, Kelantan, Malaysia
Hospital Taiping ( Site 1104)
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Taiping, Perak, Malaysia
Hospital Pulau Pinang. ( Site 1101)
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Georgetown, Pulau Pinang, Malaysia
University Malaya Medical Centre ( Site 1100)
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Kuala Lumpur, Malaysia
Life Nova+ ( Site 1203)
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Forbach, Pamplemousses, Mauritius
Bio Investigación AMARC, S.C. ( Site 1006)
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Ciudad de México, Distrito Federal, Mexico
Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)
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Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)
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Madero, Tamaulipas, Mexico
Centro de Investigacion Medica Aguascalientes ( Site 1000)
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Aguascalientes, Mexico
Centro de Atencion e Investigacion Clinica SC ( Site 1009)
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Aguascalientes, Mexico
West Visayas State University Medical Center ( Site 1401)
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Iloilo, Philippines
Federal State Budget Institution Endocrinological Research Center ( Site 1611)
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Moscow, Moskva, Russian Federation
Hera General Hospital ( Site 1725)
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Mecca, Al BaHah, Saudi Arabia
King Abdulaziz Medical City - Al Ahsa ( Site 1730)
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Al Ahsa, Ar Riyad, Saudi Arabia
King Abdul Aziz Medical City - AlRiyadh ( Site 1700)
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Riyadh, Ar Riyad, Saudi Arabia
Cukurova Uni. Tip Fakultesi ( Site 2403)
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Adana, Turkey
Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407)
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Ankara, Turkey
Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400)
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Istanbul, Turkey
Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (
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Chernivtsi, Chernivetska Oblast, Ukraine
Odessa Regional Children Clinical Hospital ( Site 1912)
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Odesa, Odeska Oblast, Ukraine
Medical Center Verum ( Site 1913)
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Kyiv, Kyivska Oblast, Ukraine
Mustafa Al Qaysi Medical Centre ( Site 2010)
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Dubai, Dubayy, United Arab Emirates
Mediclinic City Hospital ( Site 2005)
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Dubai, Dubayy, United Arab Emirates
Al Jalila Children s Specialty Hospital ( Site 2004)
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Dubai, Dubayy, United Arab Emirates
Royal London Hospital (Whitechapel) ( Site 2100)
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London, London, City Of, United Kingdom
West Middlesex University Hospital ( Site 2104)
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London, London, City Of, United Kingdom
Chelsea and Westminster Hospital ( Site 2103)
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London, London, City Of, United Kingdom
Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)
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Culiacan, Sinaloa, Mexico
Endopedia ( Site 0503)
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Guatemala, Guatemala
Soroka University Medical Center ( Site 0802)
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Beer Sheva, Israel
Armon M.C ( Site 0803)
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Haifa, Israel
Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)
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Barranquilla, Atlantico, Colombia
Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 0704)
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Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary
Wellkin Hospital ( Site 1200)
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Moka, Mauritius
Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502)
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Guatemala City, Guatemala
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705)
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Békéscsaba, Bekescsaba, Hungary
Rambam Medical Center ( Site 0801)
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Haifa, Israel
Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)
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Wierzchoslawice, Malopolskie, Poland
Bashkir State Medical University Hospital ( Site 1603)
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Ufa, Baskortostan, Respublika, Russian Federation
Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)
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Chiquimula, Guatemala
Hospital Putrajaya ( Site 1103)
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Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia
Children's City Clinical Hospital #1 ( Site 1604)
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Novosibirsk, Novosibirskaya Oblast, Russian Federation
Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)
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Rostov-on-Don, Rostovskaya Oblast, Russian Federation
Voronezh State Medical University named after N.N.Burdenko ( Site 1608)
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Voronezh, Voronezskaja Oblast, Russian Federation
Cliniques Universitaires Saint-Luc ( Site 2300)
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Brussels, Bruxelles-Capitale, Region De, Belgium
MedPlus Medicina Prepagada S.A. ( Site 0102)
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Bogota, Distrito Capital De Bogota, Colombia
Clinica Los Yoses ( Site 0200)
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San Jose, Costa Rica
CAIMED Investigación en Salud S.A de C.V ( Site 1008)
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Mexico, Distrito Federal, Mexico
Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)
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Monterrey, Nuevo Leon, Mexico
St.Petersburg State Pediatric Medical University ( Site 1600)
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Saint Petersburg, Sankt-Peterburg, Russian Federation
Kazan State Medical University ( Site 1601)
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Kazan, Tatarstan, Respublika, Russian Federation
King Abdul Aziz Medical City - AlRiyadh ( Site 1705)
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Riyadh, Ar Riyad, Saudi Arabia
Unidad de Medicina Especializada SMA ( Site 1004)
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San Juan del Río, Queretaro, Mexico
Davao Doctors Hospital ( Site 1400)
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Davao City, Davao Del Sur, Philippines
Institute for Studies on Diabetes Foundation Inc. ( Site 1402)
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Marikina, National Capital Region, Philippines
Instytut Diabetologii Sp z o o ( Site 1512)
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Warszawa, Mazowieckie, Poland
I. U. Cerrahpasa Tip Fakultesi ( Site 2406)
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Istambul, Istanbul, Turkey
Centro de Investigacion Medica de Occidente S.C. ( Site 1001)
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Guadalajara, Jalisco, Mexico
Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)
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Vinnytsia, Vinnytska Oblast, Ukraine
IN VIVO ( Site 1501)
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Bydgoszcz, Kujawsko-pomorskie, Poland
Clinical Medical Research Sp. z o.o. ( Site 1511)
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Katowice, Slaskie, Poland
Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)
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Samara, Samarskaya Oblast, Russian Federation
King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)
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Jeddah, Makkah Al Mukarramah, Saudi Arabia
Siberian State Medical University ( Site 1602)
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Tomsk, Tomskaya Oblast, Russian Federation
Dubai Diabetes Center ( Site 2002)
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Dubai, Dubayy, United Arab Emirates
King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)
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Riyadh, Ar Riyad, Saudi Arabia
King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)
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Riyadh, Ar Riyad, Saudi Arabia
Rashid Center For Diabetes and Research ( Site 2006)
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Ajman, United Arab Emirates
Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)
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Kyiv, Kyivska Oblast, Ukraine
Thumbay University Hospital ( Site 2001)
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Ajman, United Arab Emirates
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)
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Dnipro, Dnipropetrovska Oblast, Ukraine
Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915)
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Kharkiv, Kharkivska Oblast, Ukraine
Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)
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Kyiv, Kyivska Oblast, Ukraine
MHI Regional Childrens Clinical Hospital ( Site 1908)
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Kharkiv, Kharkivska Oblast, Ukraine
The University of Alabama at Birmingham ( Site 2207)
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Birmingham, Alabama, United States
London Health Sciences Centre ( Site 0002)
🇨🇦
London, Ontario, Canada
Center of Excellence in Diabetes and Endocrinology ( Site 2203)
🇺🇸
Sacramento, California, United States
Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)
🇩🇴
Santo Domingo, Distrito Nacional, Dominican Republic
Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)
🇭🇺
Budapest, Hungary

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

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts