Rilonacept in Diabetes Mellitus Type 1: Safety Study

Type 1 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962026
• Other study ID #: IL1T-AI-1022
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2009
• Last updated: February 21, 2014
• Start date: February 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Rilonacept
Rilonacept given subcutaneously, dose per package labeling, once weekly.

Locations

Country	Name	City	State
United States	Children's Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of infection in study participants		7 months	Yes
Secondary	Incidence and severity of other adverse effects in study participants		7 months	Yes
Secondary	Changes in participants' sex steroids (testosterone/estradiol)		7 months	Yes
Secondary	Changes in participants' HbA1c levels, insulin doses, and beta cell preservation		7 months	No