Rilonacept in Diabetes Mellitus Type 1: Safety Study

NCT ID: NCT00962026

Last Updated: 2014-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rilonacept

Group Type EXPERIMENTAL

Rilonacept

Intervention Type DRUG

Rilonacept given subcutaneously, dose per package labeling, once weekly.

Interventions

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Rilonacept

Rilonacept given subcutaneously, dose per package labeling, once weekly.

Intervention Type DRUG

Other Intervention Names

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Arcalyst, IL-1 Trap

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Perrin C White

Director of Pediatric Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Perrin C White, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Children's Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IL1T-AI-1022

Identifier Type: -

Identifier Source: org_study_id

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