Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
brief 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.
detailed description
Participants were randomized on Day 1 to the following arms:
* 5 mg ERTU and placebo to 15 mg ERTU (5 mg Ertugliflozin) * placebo to 5 mg ERTU and placebo to 15 mg ERTU (Placebo)
At Week 12, participants who met the up-titration criteria were re-randomized to the following arms for Weeks 12 to 54:
* 5 mg ERTU and placebo to 15 mg ERTU (5 mg/5 mg Ertugliflozin) * 15 mg ERTU and placebo to 5 mg ERTU (5 mg/15 mg Ertugliflozin) Participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU from Week 12 to Week 54.
The placebo arm continued receiving placebo from Week 12 to Week 54.
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