drugset / Trial / NCT04029480
Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
RandomizedSequentialDouble-blindTreatment
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.
Timeline
- Start
- 2019-10-08
- Primary completion
- 2025-04-11
- Completion
- 2025-04-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ertugliflozin | Unknown | 5 mg | Oral |
| Subject | Ertugliflozin | Unknown | 15 mg | Oral |
| Background | Insulin | Protein / enzyme biologic | — | — |
| Background | Metformin | Small molecule | — | — |