This site is intended for healthcare professionals
Clinical trials
  • Home
  • /
  • Clinical trials
  • /
  • Steglujan
  • /
  • Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pedi...
Clinical trial

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

Read time: 3 mins
Last updated:23rd Oct 2019
Identifier: NCT04029480

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

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

Category Value
Date last updated at source 2019-09-27
Study type(s) Interventional
Expected enrolment 150
Study start date 2019-10-24
Estimated primary completion date 2025-07-10

View full details