At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Ertugliflozin 5 mg, Ertugliflozin 15 mg, and 4 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 166 participants across 104 sites in 22 countries.
Detailed 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.
Study Details
Timeline
Interventions
Ertugliflozin 5 mg, oral, 1 tablet QD
Ertugliflozin 15 mg, oral, 1 tablet QD
Placebo to ertugliflozin 15 mg, oral, 1 tablet QD
Placebo to ertugliflozin 5 mg, oral, 1 tablet QD
Participants on insulin at screening continued to receive a stable dose of background insulin. The initiation and titration of insulin for rescue therapy was at the discretion of the investigator, based on local/regional/country guidelines.
Participants received stable dose of background metformin.