Rilonacept in Diabetes Mellitus Type 1: Safety Study

Overview

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.

Full Title of Study: “A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

Interventions

  • Drug: Rilonacept
    • Rilonacept given subcutaneously, dose per package labeling, once weekly.

Arms, Groups and Cohorts

  • Experimental: Rilonacept

Clinical Trial Outcome Measures

Primary Measures

  • Incidence and severity of infection in study participants
    • Time Frame: 7 months

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Texas Southwestern Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Perrin C White, Director of Pediatric Endocrinology – University of Texas Southwestern Medical Center
  • Overall Official(s)
    • Perrin C White, MD, Principal Investigator, University of Texas Southwestern Medical Center

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