NCT04029480

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ertugliflozin 5 mg	Ertugliflozin 5 mg, oral, 1 tablet QD
DRUG	Ertugliflozin 15 mg	Ertugliflozin 15 mg, oral, 1 tablet QD
DRUG	Placebo to ertugliflozin 15 mg	Placebo to ertugliflozin 15 mg, oral, 1 tablet QD
DRUG	Placebo to ertugliflozin 5 mg	Placebo to ertugliflozin 5 mg, oral, 1 tablet QD
BIOLOGICAL	Insulin	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.
DRUG	Metformin	Participants received stable dose of background metformin.

Timeline

• Start date: 2019-10-08
• Primary completion: 2025-04-11
• Completion: 2025-04-11
• First posted: 2019-07-23
• Last updated: 2025-10-31
• Results posted: 2025-10-31

Locations

104 sites across 22 countries: United States, Belgium, Canada, Colombia, Costa Rica, Dominican Republic, France, Guatemala, Hungary, Israel, Italy, Malaysia, Mauritius, Mexico, Philippines, Poland, Russia, Saudi Arabia, Turkey (Türkiye), Ukraine, United Arab Emirates, United Kingdom

Regulatory

• FDA-regulated drug study