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

February 21, 2014 updated by: Perrin C White, University of Texas Southwestern Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rilonacept
Drug: Rilonacept
Rilonacept given subcutaneously, dose per package labeling, once weekly.
Other Names:
  • Arcalyst, IL-1 Trap

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Perrin C White, MD, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 21, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL1T-AI-1022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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