Rilonacept in Diabetes Mellitus Type 1: Safety Study
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | February 2011 |
| End Date: | January 2013 |
| Contact: | Perrin C White, MD |
| Email: | Perrin.White@utsouthwestern.edu |
| Phone: | 214-648-3501 |
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
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