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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrin C White, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00962026
First received: August 4, 2009
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Rilonacept
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Incidence and severity of infection in study participants [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence and severity of other adverse effects in study participants [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Changes in participants' sex steroids (testosterone/estradiol) [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Changes in participants' HbA1c levels, insulin doses, and beta cell preservation [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2011
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rilonacept Drug: Rilonacept
Rilonacept given subcutaneously, dose per package labeling, once weekly.
Other Name: Arcalyst, IL-1 Trap

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962026

Locations
United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Perrin C White, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Perrin C White, Director of Pediatric Endocrinology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00962026     History of Changes
Other Study ID Numbers: IL1T-AI-1022
Study First Received: August 4, 2009
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Interleukin 1
Type 1 diabetes mellitus
Rilonacept
Arcalyst

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014