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

  • STATUS
    Recruiting
  • End date
    Jul 10, 2025
  • participants needed
    150
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 28 July 2022
insulin
body mass index
fasting
type 2 diabetes mellitus
metformin
hemoglobin a1c
c-peptide

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.

Details
Condition Type 2 Diabetes Mellitus
Treatment insulin, Placebo, Metformin, Ertugliflozin 5 mg, Ertugliflozin 15 mg
Clinical Study IdentifierNCT04029480
SponsorMerck Sharp & Dohme LLC
Last Modified on28 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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