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 (MK-8835-059/B1521066)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501085-21-00

Acronym

MK-8835-059

Enrollment

Registered

2022-11-24

Start date

2019-11-29

Completion date

2024-11-19

Last updated

2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin 5 mg and 15 mg versus placebo), Number of Participants Who Experience an Adverse Event (AE) over 24 weeks, Number of Participants Who Experience an AE over 54 weeks, Number of Participants Who Discontinue Study Treatment Due to an AE over 24 weeks, Number of Participants Who Discontinue Study Treatment Due to an AE over 54 weeks

Detailed description

Change from Baseline in Hemoglobin A1C at Week 24 (dose-optimized ertugliflozin versus placebo), Change from Baseline in Hemoglobin A1C at Week 24 (ertugliflozin 5 mg versus placebo), Change from Baseline in Fasting Plasma Glucose (FPG) at 24 weeks, Change from Baseline in Hemoglobin A1C at 54 weeks, Change from Baseline in FPG at 54 weeks

Interventions

DRUGPlacebo to Ertugliflozin film coated tablets 5mg

DRUGertugliflozin

DRUGPlacebo to ertugliflozin film coated tablets 15mg

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin 5 mg and 15 mg versus placebo), Number of Participants Who Experience an Adverse Event (AE) over 24 weeks, Number of Participants Who Experience an AE over 54 weeks, Number of Participants Who Discontinue Study Treatment Due to an AE over 24 weeks, Number of Participants Who Discontinue Study Treatment Due to an AE over 54 weeks	—

Measure

Time frame

—

Secondary

Measure	Time frame
Change from Baseline in Hemoglobin A1C at Week 24 (dose-optimized ertugliflozin versus placebo), Change from Baseline in Hemoglobin A1C at Week 24 (ertugliflozin 5 mg versus placebo), Change from Baseline in Fasting Plasma Glucose (FPG) at 24 weeks, Change from Baseline in Hemoglobin A1C at 54 weeks, Change from Baseline in FPG at 54 weeks	—

Countries

Hungary, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026