Detemir vs. NPH in Children and Adolescents With Type 2 Diabetes
A trial investigating the safety and efficacy of the blood sugar lowering effects of insulin detemir to NPH insulin, both in combination with metformin
Study sponsors
Novo Nordisk
Principal investigator
Steven Willi, MD, director of the Diabetes Center at CHOP
Who can participate?
- Ages 10 to 17 years old
- Diagnosed with type 2 diabetes
- Taking 1000-2000 mg of metformin for at least three months prior to screening
- Using insulin daily for at least three months
- Hemoglobin A1C ≥ 7% and ≤ 10.5%
- In good general health
What is this study about?
The purpose of this research study is to compare how long-acting insulin detemir (Levemir®) and NPH lower blood sugar when taken with metformin and combined with diet and exercise in patients with type 2 diabetes. Both are approved for treatment of type 1 diabetes and are used with other insulin products and anti-diabetic medications.
What does participation involve?
If you decide that you want to participate, 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 exam
- Blood and urine samples collection for testing
Eligible volunteers that consent to participate will be randomly assigned to one of two groups. One group will be given the insulin detemir, and the other group will receive NPH insulin. Both groups will receive metformin.
A few things you should know about participating in this study:
Participation is voluntary and you may quit the study at any time, for any reason
How long will this study last?
Participation will last 8-9 months
Reimbursement
Participants will be compensated for travel and related expenses. All study-related care, supplies and study drug are provided at no cost to you.
More information
For more information, please visit the study page at ClinicalTrials.gov.
If interested
Please email diabetesresearch@email.chop.edu or call 267-426-7519.
IRB # 14-011159
Approval 2/3/15
Expiration 8/5/15
