Single Dose Pharmacokinetic Study of Cycloset® 0.8 mg Tablets Following Administration of a Weight-Adjusted Dose in Male and Female Children and Adolescents with Type 2 Diabetes Mellitus Subjects
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
- Do not require insulin injections
- In good general health
What is this study about?
The purpose of this research study is to see how much of the new medication, Cycloset, gets into the bloodstream after taking a tablets by mouth and how safe it is. Cycloset is an FDA-approved medication for the treatment of Type 2 Diabetes in adults.
What does participation involve?
The study consists of a Screening visit, a Treatment period (3 days inpatient stay).
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 receive one dose of 3 to 6 tablets (2.4 mg to 4.8 mg) of Cycloset, depending on your weight, while on the inpatient floor. To help lessen the nausea and avoid vomiting, you will also take a liquid medicine called Ondansetron, four hours before taking Cycloset.
How long will this study last?
Total clinical trial participation may last up to 31 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 receive stipend for the completed study visits and reimbursement for their travel and meals.
Please email email@example.com or call: 267-426-7519
CHOP IRB#: IRB 14-011009
Effective Date: 7/23/2014
Expiration Date: 5/6/2015