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CompletedNCT04029480Updated Oct 31, 2025Results posted

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

A Phase 3 interventional study of Ertugliflozin 5 mg and Ertugliflozin 15 mg in Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme LLC. Completed at 104 sites in 22 countries. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-10-31.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

  • Be ≥10 years and ≤17 years of age, when the informed consent is signed
  • Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
  • Has body mass index (BMI) ≥85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
  • T2DM for ≥2 years, OR T2DM for \<2 years and a fasting C-peptide value >0.6 ng/mL at Screening.
  • On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, OR on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and a stable dose of insulin for ≥8 weeks prior to Screening.
  • Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Is a non-sterilized female who is currently not sexually active OR who agrees to abstain from heterosexual activity OR who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.

Exclusion criteria

Exclusion Criteria:

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

  • Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.
  • Has known monogenic diabetes, or secondary diabetes.
  • Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin.
  • Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
  • Is pregnant, or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study medication.
  • Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
  • Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
  • Has a history of severe hypoglycemia while on insulin.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
166 participants (actual)

Study arms

  • Experimental
    Ertugliflozin 5 mg

    All participants initially received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.

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

  • Experimental
    Ertugliflozin 5 mg/5 mg

    All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.

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

  • Experimental
    Ertugliflozin 5 mg/15 mg

    All participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until Week 12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were up-titrated to 15 mg ERTU and placebo to 5 mg ERTU from WK12 to WK54.

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

  • Placebo comparator
    Placebo

    All participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.

    Drug: Placebo to ertugliflozin 15 mg · Drug: Placebo to ertugliflozin 5 mg · Biological: Insulin · Drug: Metformin

Interventions

  • DrugErtugliflozin 5 mg

    Ertugliflozin 5 mg, oral, 1 tablet QD

    Also known as: MK-8835, PF-04971729

  • DrugErtugliflozin 15 mg

    Ertugliflozin 15 mg, oral, 1 tablet QD

    Also known as: MK-8835, PF-04971729

  • DrugPlacebo to ertugliflozin 15 mg

    Placebo to ertugliflozin 15 mg, oral, 1 tablet QD

  • DrugPlacebo to ertugliflozin 5 mg

    Placebo to ertugliflozin 5 mg, oral, 1 tablet QD

  • BiologicalInsulin

    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.

  • DrugMetformin

    Participants received stable dose of background metformin.

05

What researchers measure

Primary outcomes

  1. Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)

    Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The Bayesian mean change from baseline for each combined ertugliflozin and placebo are reported. Per protocol, the ertugliflozin arms are combined for this analysis.

    Time frame: Baseline and Week 24

  2. Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24

    An adverse event -- Select --is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

    Time frame: Up to Week 24

  3. Number of Participants Who Experienced an AE Up to Week 54

    An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

    Time frame: Up to Week 54

  4. Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24

    An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

    Time frame: Up to Week 24

  5. Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 54

    An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

    Time frame: Up to Week 54

Secondary outcomes

  1. Change From Baseline in Hemoglobin A1C at Week 24 (Dose-optimized Ertugliflozin Versus Placebo)

    Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.

    Time frame: Baseline and Week 24

  2. Change From Baseline in Hemoglobin A1C at Week 24 (5 mg Ertugliflozin Versus Placebo)

    Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.

    Time frame: Baseline and Week 24

  3. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.

    Time frame: Baseline and Week 24

  4. Change From Baseline in Hemoglobin A1C at Week 54

    Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 54 to determine the A1C change from baseline (i.e., A1C at Week 54 minus A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.

    Time frame: Baseline and Week 54

  5. Change From Baseline in FPG at Week 54

    Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.

    Time frame: Baseline and Week 54

06

Results

Posted Oct 31, 2025

Participant flow

Participant flow — Overall Study
Milestone5 mg Ertugliflozin5 mg/5 mg Ertugliflozin5 mg/15 mg ErtugliflozinPlacebo
Started63222655
Re-randomized022260
Completed61222353
Not completed2032
Withdrew: Physician decision0021
Withdrew: Withdrawal by subject2011

Outcome measures

PrimaryChange 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.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · A1C Percentage
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)
A1C PercentageCombined ErtugliflozinPlacebo
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)-0.55 (-0.82 to -0.28)0.12 (-0.23 to 0.47)
Statistical analysis
  • Combined Ertugliflozin vs Placebo · Difference in bayesian means: -0.67 · 95% CI -1.06 to -0.29
PrimaryNumber 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.

Time frame:
Up to Week 24
Reported as:
Count of participants · Participants
Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24
ParticipantsCombined ErtugliflozinPlacebo
Number of Participants Who Experienced an Adverse Event (AE) Up to Week 245933
Statistical analysis
  • Combined Ertugliflozin vs Placebo · Difference in percent: -6.8 · 95% CI -22.2 to 9.3
PrimaryNumber 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.

Time frame:
Up to Week 54
Reported as:
Count of participants · Participants
Number of Participants Who Experienced an AE Up to Week 54
ParticipantsCombined ErtugliflozinPlacebo
Number of Participants Who Experienced an AE Up to Week 547142
Statistical analysis
  • Combined Ertugliflozin vs Placebo · Difference in percent: -12.4 · 95% CI -25.9 to 2.8
PrimaryNumber 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.

Time frame:
Up to Week 24
Reported as:
Count of participants · Participants
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24
ParticipantsCombined ErtugliflozinPlacebo
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 2400
Statistical analysis
  • Combined Ertugliflozin vs Placebo · Difference in percent: 0.00No confidence intervals (CIs) were calculated. CIs were computed only for those endpoints where at least ≥8 participants in the combined ertugliflozin group or ≥2 participants in the placebo group had events.
PrimaryNumber 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.

Time frame:
Up to Week 54
Reported as:
Count of participants · Participants
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 54
ParticipantsCombined ErtugliflozinPlacebo
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 5401
Statistical analysis
  • Combined Ertugliflozin vs Placebo · Difference in percent: -1.8No confidence intervals (CIs) were calculated. CIs were computed only for those endpoints where at least ≥8 participants in the combined ertugliflozin group or ≥2 participants in the placebo group had events.
SecondaryChange 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.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · A1C Percentage
Change From Baseline in Hemoglobin A1C at Week 24 (Dose-optimized Ertugliflozin Versus Placebo)
A1C PercentageDose-Optimized ErtugliflozinPlacebo
Change From Baseline in Hemoglobin A1C at Week 24 (Dose-optimized Ertugliflozin Versus Placebo)-0.42 (-0.76 to -0.08)0.25 (-0.22 to 0.72)
Statistical analysis
  • Dose-Optimized Ertugliflozin vs Placebo · ANCOVA · p = 0.021 · Difference in least squares means: -0.66 · 95% CI -1.23 to -0.10
SecondaryChange 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.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · A1C Percentage
Change From Baseline in Hemoglobin A1C at Week 24 (5 mg Ertugliflozin Versus Placebo)
A1C Percentage5 mg ErtuglifozinPlacebo
Change From Baseline in Hemoglobin A1C at Week 24 (5 mg Ertugliflozin Versus Placebo)-0.54 (-0.86 to -0.22)0.32 (-0.11 to 0.76)
Statistical analysis
  • 5 mg Ertuglifozin vs Placebo · ANCOVA · p = 0.001 · Difference in least squares means: -0.86 · 95% CI -1.39 to -0.33
SecondaryChange 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.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · mg/dL
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
mg/dLCombined ErtugliflozinPlacebo
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24-20.8 (-30.8 to -10.8)8.2 (-5.4 to 21.7)
Statistical analysis
  • Combined Ertugliflozin vs Placebo · cLDA · p = 0.001 · Difference in least squares means: -29.0 · 95% CI -44.4 to -13.6
SecondaryChange 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.

Time frame:
Baseline and Week 54
Reported as:
Least squares mean · AIC Percentage
Change From Baseline in Hemoglobin A1C at Week 54
AIC PercentageCombined ErtugliflozinPlacebo
Change From Baseline in Hemoglobin A1C at Week 54-0.22 (-0.59 to 0.16)0.81 (0.24 to 1.38)
Statistical analysis
  • Combined Ertugliflozin vs Placebo · cLDA · p = 0.003 · Difference in least squares means: -1.03 · 95% CI -1.70 to -0.35
SecondaryChange 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.

Time frame:
Baseline and Week 54
Reported as:
Least squares mean · mg/dL
Change From Baseline in FPG at Week 54
mg/dLCombined ErtugliflozinPlacebo
Change From Baseline in FPG at Week 54-12.1 (-23.7 to -0.5)21.0 (3.6 to 38.4)
Statistical analysis
  • Combined Ertugliflozin vs Placebo · cLDA · p = 0.001 · Difference in least squares means: -33.1 · 95% CI -53.0 to -13.1

Adverse events

Collected over Up to 56 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
5 mg Ertugliflozin: Week 1-540/63 (0%)2/63 (3.2%)29/63 (46%)
5 mg/5 mg Ertugliflozin: Week 1-540/22 (0%)1/22 (4.5%)11/22 (50%)
5 mg/15 mg Ertugliflozin: Week 1-12 (Ertu 5 mg)0/26 (0%)0/26 (0%)8/26 (30.8%)
5 mg/15 mg Ertugliflozin: Week 12-54 (Ertu 15 mg)0/26 (0%)1/26 (3.8%)14/26 (53.8%)
Placebo: Week 1-540/55 (0%)0/55 (0%)31/55 (56.4%)
Most frequent serious events
Most frequent serious events
Event5 mg Ertugliflozin: Week 1-545 mg/5 mg Ertugliflozin: Week 1-545 mg/15 mg Ertugliflozin: Week 1-12 (Ertu 5 mg)5 mg/15 mg Ertugliflozin: Week 12-54 (Ertu 15 mg)Placebo: Week 1-54
COVID-19 pneumoniaInfections and infestations0/631/220/260/260/55
HypoglycaemiaMetabolism and nutrition disorders0/630/220/261/260/55
Post procedural infectionInfections and infestations1/630/220/260/260/55
Foot fractureInjury, poisoning and procedural complications1/630/220/260/260/55
Tibia fractureInjury, poisoning and procedural complications1/630/220/260/260/55
HyperglycaemiaMetabolism and nutrition disorders1/630/220/260/260/55
Most frequent other events
Showing 10 of 19
Most frequent other events
Event5 mg Ertugliflozin: Week 1-545 mg/5 mg Ertugliflozin: Week 1-545 mg/15 mg Ertugliflozin: Week 1-12 (Ertu 5 mg)5 mg/15 mg Ertugliflozin: Week 12-54 (Ertu 15 mg)Placebo: Week 1-54
HypoglycaemiaMetabolism and nutrition disorders7/632/223/265/267/55
NauseaGastrointestinal disorders2/633/222/264/264/55
VomitingGastrointestinal disorders1/632/222/264/263/55
Upper respiratory tract infectionInfections and infestations9/631/221/261/266/55
HeadacheNervous system disorders5/631/221/263/263/55
Abdominal painGastrointestinal disorders1/632/221/262/263/55
DiarrhoeaGastrointestinal disorders0/632/220/261/264/55
GastroenteritisInfections and infestations3/630/220/261/265/55
PharyngitisInfections and infestations1/632/220/260/261/55
COVID-19Infections and infestations5/631/220/262/264/55

Baseline characteristics

Age, Continuous
Age, Continuous(years)5 mg Ertugliflozin5 mg/5 mg Ertugliflozin5 mg/15 mg ErtugliflozinPlaceboTotal
Mean14.4 ± 2.014.6 ± 2.015.6 ± 1.815.1 ± 1.714.8 ± 1.9
Age, Customized
Age, Customized(Participants)5 mg Ertugliflozin5 mg/5 mg Ertugliflozin5 mg/15 mg ErtugliflozinPlaceboTotal
In utero00000
Preterm newborn infants (gestational age < 37 wks)00000
Newborns (0-27 days)00000
Infants and toddlers (28 days-23 months)00000
Children (2-11 years)62019
Adolescents (12-17 years)56202452152
Adults (18-64 years)10225
From 65-84 years00000
85 years and over00000
Sex: Female, Male
Sex: Female, Male(Participants)5 mg Ertugliflozin5 mg/5 mg Ertugliflozin5 mg/15 mg ErtugliflozinPlaceboTotal
Female3810203098
Male251262568
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)5 mg Ertugliflozin5 mg/5 mg Ertugliflozin5 mg/15 mg ErtugliflozinPlaceboTotal
Hispanic or Latino33892272
Not Hispanic or Latino3013173393
Unknown or Not Reported01001
Race (NIH/OMB)
Race (NIH/OMB)(Participants)5 mg Ertugliflozin5 mg/5 mg Ertugliflozin5 mg/15 mg ErtugliflozinPlaceboTotal
American Indian or Alaska Native635519
Asian7531025
Native Hawaiian or Other Pacific Islander00000
Black or African American00415
White4312133199
More than one race721818
Unknown or Not Reported00000
Baseline A1C
Baseline A1C(A1C Percentage)5 mg Ertugliflozin5 mg/5 mg Ertugliflozin5 mg/15 mg ErtugliflozinPlaceboTotal
Mean7.6 ± 1.08.5 ± 1.18.8 ± 0.98.0 ± 1.08.0 ± 1.1
Insulin Use at Screening
Insulin Use at Screening(Participants)5 mg Ertugliflozin5 mg/5 mg Ertugliflozin5 mg/15 mg ErtugliflozinPlaceboTotal
Yes1814172473
No45893193
Age at Screening
Age at Screening(Years)5 mg Ertugliflozin5 mg/5 mg Ertugliflozin5 mg/15 mg ErtugliflozinPlaceboTotal
10 to 14 years of age271182369
15 to 17 years of age3611183297
07

Study locations

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

Showing the first 100 of 104 sites across 22 countries.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 14, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

09

Registry details

Key details

Study ID
NCT04029480
Lead sponsor
Merck Sharp & Dohme LLC
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Jul 23, 2019
Start date
Oct 8, 2019
Primary completion
Apr 11, 2025
Completion
Apr 11, 2025
Results posted
Oct 31, 2025
Last update
Oct 31, 2025

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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