New Onset of Type 1 Diabetes – Imatinib

Study name

Safety and Efficacy of Imatinib for Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus

Study sponsor

Juvenile Diabetes Research Foundation International

Principal investigator

Steven Willi, MD, Director of the Diabetes Center at CHOP

Who can participate?

• New onset type 1 diabetes, within 100 days of diagnosis
• 18 to 45 years of age
• In good general health

What is this study about?

The purpose of this research study is to see if imatinib might slow or halt the progression of Type 1 diabetes mellitus in newly diagnosed individuals and to learn more about its safety. Imatinib is a medication that subdues the immune system and is FDA-approved for the treatment of several types of cancer, including chronic myelogenous leukemia.

What does participation involve?

All study visits will take place at CHOP. 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
• Electrocardiogram (ECG)

Eligible volunteers that consent to participate will be randomly assigned to one of two groups. One group will be given the study drug, imatinib, and the other group will receive an inactive substance made to look like the study drug, called a placebo. Neither you nor the study physicians or nurses will know to which group you have been assigned. There is no guarantee that imatinib will work, or that you will receive the active drug (rather than the placebo).

Participants will receive a total of 26 weeks of daily oral tablets of either imatinib or placebo. All participants will receive intensive diabetes management from a certified diabetes educator. This management will be in addition to any care you currently receive from your primary care physician.

How long will this study last?

Total clinical trial participation will last about two years.

Reimbursement

Participants will be compensated for travel and related expenses. Study-related care and study-related diabetes supplies are provided at no cost to you.

More information

Please visit http://clinicaltrials.gov/ct2/show/study/NCT01781975 for more information about the study.

If you are interested in the study

Please email diabetesresearch@email.chop.edu or call: 267-426-7519.

CHOP IRB#: IRB 13-010022

Effective Date: 2/25/2014

Expiration Date: 10/15/2014