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COMPLETED Phase 3

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

NCT04029480 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG Ertugliflozin 5 mg
  • DRUG Ertugliflozin 15 mg
  • DRUG Placebo to ertugliflozin 15 mg
  • DRUG Placebo to ertugliflozin 5 mg
  • BIOLOGICAL Insulin

Study Locations (20)

California

  • Children's Hospital - Los Angeles ( Site 2201) — Los Angeles
  • Center of Excellence in Diabetes and Endocrinology ( Site 2203) — Sacramento

Alabama

  • The University of Alabama at Birmingham ( Site 2207) — Birmingham

Florida

  • Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si — Hollywood

Illinois

  • ICCT Research International, Inc. ( Site 2211) — Chicago

Maryland

  • Barry J. Reiner MD LLC ( Site 2204) — Baltimore

Michigan

  • William Beaumont Hospital ( Site 2219) — Royal Oak

New York

  • CHEAR Center LLC ( Site 2200) — The Bronx

North Carolina

  • Coastal Children''s Services ( Site 2202) — Wilmington

Trial Details

FieldValue
Enrollment Target 166 participants
Start Date 2019-10-08
Est. Completion 2025-04-11
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04029480

The ClinicalTrials.gov registry entry for NCT04029480 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions — of which Ertugliflozin 5 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04029480 reports 20 study locations spanning 19 distinct geographic areas — top geographies include California, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04029480 about?

NCT04029480 is a clinical study titled "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...

What is the current status of trial NCT04029480?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2019-10-08. Estimated completion is 2025-04-11.

What conditions does trial NCT04029480 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04029480?

The interventions under investigation include: Ertugliflozin 5 mg (DRUG), Ertugliflozin 15 mg (DRUG), Placebo to ertugliflozin 15 mg (DRUG), Placebo to ertugliflozin 5 mg (DRUG), Insulin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04029480?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04029480 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial