Rilonacept in Diabetes Mellitus Type 1: Safety Study

Completed · Phase 1

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00962026

Run by

University of Texas Southwestern Medical Center

People needed

13

Starts

2011-02-01

Expected to finish

2013-06-01

Last updated by the study team

2014-02-24

Who can join

Age: 16 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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