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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT04029480

Run by

Merck Sharp & Dohme LLC

People needed

166

Starts

2019-10-08

Expected to finish

2025-04-11

Last updated by the study team

2025-10-31

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital - Los Angeles ( Site 2201) — Los Angeles, California, United States
• Center of Excellence in Diabetes and Endocrinology ( Site 2203) — Sacramento, California, United States
• Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si — Hollywood, Florida, United States
• ICCT Research International, Inc. ( Site 2211) — Chicago, Illinois, United States
• Barry J. Reiner MD LLC ( Site 2204) — Baltimore, Maryland, United States
• William Beaumont Hospital ( Site 2219) — Royal Oak, Michigan, United States
• CHEAR Center LLC ( Site 2200) — The Bronx, New York, United States
• Coastal Children''s Services ( Site 2202) — Wilmington, North Carolina, United States
• The Children's Hospital of Philadelphia ( Site 2205) — Philadelphia, Pennsylvania, United States
• Southern Endocrinology and Associates PA ( Site 2218) — Mesquite, Texas, United States
• Cliniques Universitaires Saint-Luc ( Site 2300) — Brussels, Bruxelles-Capitale, Region de, Belgium
• London Health Sciences Centre ( Site 0002) — London, Ontario, Canada
• Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001) — Montreal, Quebec, Canada
• Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101) — Barranquilla, Atlántico, Colombia
• MedPlus Medicina Prepagada S.A. ( Site 0102) — Bogotá, Bogota D.C., Colombia
• Clinica Los Yoses ( Site 0200) — San José, Costa Rica
• Hospital Infantil Dr. Robert Reid Cabral ( Site 0300) — Santo Domingo, Nacional, Dominican Republic
• CHU du BOCAGE ( Site 0407) — Dijon, Cote-d Or, France
• CHU Amiens Hopital Sud ( Site 0413) — Amiens, Picardie, France
• Consultorio Privado Dr. Geraldine Utrilla ( Site 0501) — Chiquimula, Guatemala
• Endopedia ( Site 0503) — Guatemala City, Guatemala
• Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502) — Guatemala City, Guatemala
• Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708) — Pécs, Baranya, Hungary
• Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705) — Békéscsaba, Bekescsaba, Hungary
• The University of Alabama at Birmingham ( Site 2207) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.