Rilonacept in Diabetes Mellitus Type 1: Safety Study

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Rilonacept

Criteria

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