A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years with Type 2 Diabetes Mellitus
Bristol-Myers Squibb Research and Development
Steven Willi, MD, Director of the Diabetes Center at CHOP
Who can participate?
- Children and adolescents between 10 and 17 years old
- Diagnosed with Type 2 Diabetes
- In good general health
What is this study about?
The purpose of this research study is to see how much of the new medication, Dapagliflozin, gets into the bloodstream after taking a tablet by mouth and how safe it is.
What does participation involve?
The study consists of a Screening visit, a Treatment period (2 days inpatient stay and 1 outpatient clinic visit).
If you decide that you want to determine if you qualify for this study, you will be scheduled to come to the research clinic at CHOP for a screening visit where you can expect:
- Interviews about your medical history
- Physical examination
- Blood and urine samples collection for testing
Eligible volunteers who consent to participate will be randomly assigned to one of 3 groups to receive one dose of 2.5 mg, 5mg or 10mg of Dapagliflozin orally while on the inpatient floor. After being discharged from the hospital, subjects will return to the clinic the following day for a blood sample collection and other study procedures.
How long will this study last?
Total clinical trial participation may last up to 24 days, depending on when the treatment begins after the screening visit.
Study-related care and supplies are provided at no cost to you. Participants will be compensated for travel and related expenses. In addition, volunteers will be compensated for the completed study visits.
Please email firstname.lastname@example.org or call: 267-426-7519
CHOP IRB#: IRB 12-009349
Effective Date: 5/8/2014
Expiration Date: 5/6/2015