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

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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 150 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date: October 24, 2019
Estimated Primary Completion Date: July 10, 2025
Estimated Study Completion Date: July 10, 2025

Arms:
- Experimental: Ertugliflozin 5 mg/5 mg
- Experimental: Ertugliflozin 5 mg/15 mg
- Placebo Comparator: Placebo