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

Send

Updated on 28 July 2022

See if I qualify

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 Identifier	NCT04029480
Sponsor	Merck Sharp & Dohme LLC
Last Modified on	28 July 2022

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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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Step 3 Enroll in the clinical study

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Step 4 Get your study results

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