Rilonacept in Diabetes Mellitus Type 1: Safety Study

A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus

This study is being done to see if an investigational drug called rilonacept is safe to use in patients with type 1 diabetes, and if it can slow the loss of the body's ability to secrete insulin in patients who are still able to make a small amount of insulin.

Inclusion Criteria:

• Within 5 years of diagnosis of type 1 diabetes
• Between the ages of 16 to 45 years
• Have at least one diabetes-related autoantibody present
• Have mean C-peptide level > 0.2 nmol/L on a mixed meal tolerance test
• Be taking insulin
• Complete written informed consent

Exclusion Criteria:

• Taking inhaled or oral steroids (for example Advair, Orapred)
• Have an active infection
• Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
• Have ongoing use of medications known to affect glucose tolerance
• Have a live vaccine 90 days prior to, or during this study
• Taking any other experimental medication within the past 28 days
• Have prior treatment with rilonacept
• Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
• Pregnant or lactating females
• Males and females unwilling to use an acceptable method of contraception for the duration of the study