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NCT04029480 · ClinicalTrials.gov registry record · Phase 3
Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
A Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 166
- Enrollment target
- 20
- Study locations
NCT04029480: Completed Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme.
NCT04029480 is a Phase 3 study of Type 2 Diabetes Mellitus that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 166 participants, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04029480, a Phase 3 study of Type 2 Diabetes Mellitus, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 166 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The Bayesian mean change from baseline for each combined ertugliflozin and placebo are reported. Per protocol, the ertugli
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
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2025-04-11 |
| Phase | Phase 3 |
What the finished NCT04029480 record still lists
NCT04029480 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (94% lower).
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.
NCT04029480 names 20 study sites across 19 states, led by California, Alabama, Florida.
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.
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).
Who is sponsoring clinical trial NCT04029480?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04029480's enrollment target sits among peer trials
166 44th of 130 higher than 87 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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