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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rilonacept
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Interleukin 1, Type 1 diabetes mellitus, Rilonacept, Arcalyst

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rilonacept

Arm Description

Outcomes

Primary Outcome Measures

Incidence and severity of infection in study participants

Secondary Outcome Measures

Incidence and severity of other adverse effects in study participants
Changes in participants' sex steroids (testosterone/estradiol)
Changes in participants' HbA1c levels, insulin doses, and beta cell preservation

Full Information

First Posted
August 4, 2009
Last Updated
February 21, 2014
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00962026
Brief Title
Rilonacept in Diabetes Mellitus Type 1: Safety Study
Acronym
RID-A
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Interleukin 1, Type 1 diabetes mellitus, Rilonacept, Arcalyst

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rilonacept
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rilonacept
Other Intervention Name(s)
Arcalyst, IL-1 Trap
Intervention Description
Rilonacept given subcutaneously, dose per package labeling, once weekly.
Primary Outcome Measure Information:
Title
Incidence and severity of infection in study participants
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Incidence and severity of other adverse effects in study participants
Time Frame
7 months
Title
Changes in participants' sex steroids (testosterone/estradiol)
Time Frame
7 months
Title
Changes in participants' HbA1c levels, insulin doses, and beta cell preservation
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perrin C White, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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Rilonacept in Diabetes Mellitus Type 1: Safety Study

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