A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus

Rilonacept in Diabetes Mellitus Type 1: Safety Study

Sponsors

Lead sponsor: University of Texas Southwestern Medical Center

Source 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.

Overall Status Completed
Start Date February 2011
Completion Date June 2013
Primary Completion Date March 2013
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence and severity of infection in study participants 7 months
Secondary Outcome
Measure Time Frame
Incidence and severity of other adverse effects in study participants 7 months
Changes in participants' sex steroids (testosterone/estradiol) 7 months
Changes in participants' HbA1c levels, insulin doses, and beta cell preservation 7 months
Enrollment 13
Condition
Intervention

Intervention type: Drug

Intervention name: Rilonacept

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

Arm group label: Rilonacept

Other name: Arcalyst, IL-1 Trap

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

Gender: All

Minimum age: 16 Years

Maximum age: 45 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Perrin C White, MD Principal Investigator University of Texas Southwestern Medical Center
Location
facility Children's Medical Center
Location Countries

United States

Verification Date

February 2014

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Texas Southwestern Medical Center

Investigator full name: Perrin C White

Investigator title: Director of Pediatric Endocrinology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Rilonacept

Arm group type: Experimental

Acronym RID-A
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov