Ertugliflozin for Children and Adolescents with Type 2 Diabetes

Ertugliflozin for Children and Adolescents with Type 2 Diabetes

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 If you are interested in participating in the study or want to learn more, please contact: Contact us
This study is no longer recruiting.

Description
You are invited to take part in a voluntary research trial because you have type 2 diabetes and are between the ages of 10 and 17 years. You will be given a placebo or Ertugliflozin, which has been approved in the United States by the FDA for treatment of type 2 diabetes in adults but not in children. If you meet all criteria, you will be asked to come to CHOP for 8 study visits and have 4 phone calls for a total of approximately 60 weeks. Besides oral administration of the study product (a pill taken daily), the study procedures include: review of medical records, physical exam, EKG, blood and urine tests, renal ultrasounds, nutritional and physical activity counseling, and diary completion. You will be compensated for your time and effort committed to the study and reimbursed for your travel expenses.

Eligibility and criteria
IRB Number:
19-016491
Eligible age range:
10 years - 17 years
Clinical trial phase:
Phase III
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
Smiling CHOP patient holding shopping bag

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Your time and participation make a difference in supporting the work of the Research Institute and children in our community. Learn more about opportunities to participate in our research.