Status:
COMPLETED
Rilonacept in Diabetes Mellitus Type 1: Safety Study
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
16-45 years
Phase:
PHASE1
Brief 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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00962026
Start Date
February 1 2011
End Date
June 1 2013
Last Update
February 24 2014
Active Locations (1)
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1
Children's Medical Center
Dallas, Texas, United States, 75235