Rilonacept in Diabetes Mellitus Type 1: Safety Study (RID-A)

The University of Texas System (UT)

Status and phase

Completed

Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: Rilonacept

Study type

Interventional

Funder types

Other

Identifiers

NCT00962026

IL1T-AI-1022

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

16 to 45 years old

Volunteers

No Healthy Volunteers

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