Rilonacept in Diabetes Mellitus Type 1: Safety Study

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Rilonacept

• Registration Number: NCT00962026
• Lead Sponsor: University of Texas Southwestern Medical Center

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 patients who are still able to make a small amount of insulin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-17
• Study First Posted: 2009-08-19
• Study Start: 2011-02
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-21
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rilonacept	Rilonacept	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of infection in study participants	7 months

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of other adverse effects in study participants	7 months
Changes in participants' sex steroids (testosterone/estradiol)	7 months
Changes in participants' HbA1c levels, insulin doses, and beta cell preservation	7 months

Trial Locations

Locations (1)

Children's Medical Center; 🇺🇸 Dallas, Texas, United States