Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
Public ClinicalTrials.gov record NCT04029480. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04029480
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 166 participants
Conditions and interventions
Conditions
Interventions
- Ertugliflozin 5 mg Drug
- Ertugliflozin 15 mg Drug
- Placebo to ertugliflozin 15 mg Drug
- Placebo to ertugliflozin 5 mg Drug
- Insulin Biological
- Metformin Drug
Drug · Biological
Eligibility (public fields only)
- Age range
- 10 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 7, 2019
- Primary completion
- Apr 10, 2025
- Completion
- Apr 10, 2025
- Last update posted
- Oct 30, 2025
2019 – 2025
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham ( Site 2207) | Birmingham | Alabama | 35233-1711 | — |
| Children's Hospital - Los Angeles ( Site 2201) | Los Angeles | California | 90027 | — |
| Center of Excellence in Diabetes and Endocrinology ( Site 2203) | Sacramento | California | 95821 | — |
| Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si | Hollywood | Florida | 33021 | — |
| ICCT Research International, Inc. ( Site 2211) | Chicago | Illinois | 60659 | — |
| Barry J. Reiner MD LLC ( Site 2204) | Baltimore | Maryland | 21229 | — |
| William Beaumont Hospital ( Site 2219) | Royal Oak | Michigan | 48073 | — |
| CHEAR Center LLC ( Site 2200) | The Bronx | New York | 10455 | — |
| Coastal Children''s Services ( Site 2202) | Wilmington | North Carolina | 28403 | — |
| The Children's Hospital of Philadelphia ( Site 2205) | Philadelphia | Pennsylvania | 19104 | — |
| Southern Endocrinology and Associates PA ( Site 2218) | Mesquite | Texas | 75149 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 93 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04029480, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 30, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04029480 live on ClinicalTrials.gov.