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Completed

NCT Number: NCT04029480

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cliniques Universitaires Saint-Luc ( Site 2300), Brussels, Bruxelles-Capitale, Region de, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

Ertugliflozin 5 mg

Drug

Ertugliflozin 5 mg, oral, 1 tablet QD

Other names: MK-8835, PF-04971729

Ertugliflozin 15 mg

Drug

Ertugliflozin 15 mg, oral, 1 tablet QD

Other names: MK-8835, PF-04971729

Placebo to ertugliflozin 15 mg

Drug

Placebo to ertugliflozin 15 mg, oral, 1 tablet QD

Placebo to ertugliflozin 5 mg

Drug

Placebo to ertugliflozin 5 mg, oral, 1 tablet QD

Insulin

Biological

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.

metformin

Drug

Participants received stable dose of background metformin.

Primary outcomes

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

    Time frame: Baseline and Week 24

    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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Baseline and Week 24

    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.

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

    Time frame: Baseline and Week 24

    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.

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

    Time frame: Baseline and 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.

  4. Change From Baseline in Hemoglobin A1C at Week 54

    Time frame: Baseline and 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.

  5. Change From Baseline in FPG at Week 54

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2019
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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