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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00962026
Recruitment Status : Completed
First Posted : August 19, 2009
Last Update Posted : February 24, 2014
Information provided by (Responsible Party):
Perrin C White, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Rilonacept Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Rilonacept

Arm Intervention/treatment
Experimental: Rilonacept Drug: Rilonacept
Rilonacept given subcutaneously, dose per package labeling, once weekly.
Other Name: Arcalyst, IL-1 Trap

Primary Outcome Measures :
  1. Incidence and severity of infection in study participants [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Incidence and severity of other adverse effects in study participants [ Time Frame: 7 months ]
  2. Changes in participants' sex steroids (testosterone/estradiol) [ Time Frame: 7 months ]
  3. Changes in participants' HbA1c levels, insulin doses, and beta cell preservation [ Time Frame: 7 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00962026

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

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Responsible Party: Perrin C White, Director of Pediatric Endocrinology, University of Texas Southwestern Medical Center Identifier: NCT00962026     History of Changes
Other Study ID Numbers: IL1T-AI-1022
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014
Keywords provided by Perrin C White, University of Texas Southwestern Medical Center:
Interleukin 1
Type 1 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents