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
Abstract
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.
Conditions: Type 2 Diabetes Mellitus.
Primary outcome: Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo); Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24; Number of Participants Who Experienced an AE Up to Week 54; Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24; Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 54.
Enrollment: 166 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 166 participants or records.
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