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

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

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.

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

10 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-08

Primary Completion

2025-04-11

Completion

2025-04-11

FDA Drug

Yes

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

Study Locations