Status:
COMPLETED
Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Pfizer
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief 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...
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, partici...
Eligibility Criteria
Inclusion
- The main inclusion criteria include but are not limited to the following:
- Be ≥10 years and ≤17 years of age, when the informed consent is signed
- Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
- Has body mass index (BMI) ≥85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
- T2DM for ≥2 years, OR T2DM for \<2 years and a fasting C-peptide value \>0.6 ng/mL at Screening.
- On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, OR on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and a stable dose of insulin for ≥8 weeks prior to Screening.
- Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Is a non-sterilized female who is currently not sexually active OR who agrees to abstain from heterosexual activity OR who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.
Exclusion
- The main exclusion criteria include but are not limited to the following:
- Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.
- Has known monogenic diabetes, or secondary diabetes.
- Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin.
- Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
- Is pregnant, or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study medication.
- Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
- Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
- Has a history of severe hypoglycemia while on insulin.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04029480
Start Date
October 8 2019
End Date
April 11 2025
Last Update
October 31 2025
Active Locations (104)
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1
The University of Alabama at Birmingham ( Site 2207)
Birmingham, Alabama, United States, 35233-1711
2
Children's Hospital - Los Angeles ( Site 2201)
Los Angeles, California, United States, 90027
3
Center of Excellence in Diabetes and Endocrinology ( Site 2203)
Sacramento, California, United States, 95821
4
Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si
Hollywood, Florida, United States, 33021