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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014