Rilonacept in Diabetes Mellitus Type 1: Safety Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00962026

Acronym

RID-A

Enrollment

Registered

2009-08-19

Start date

2011-02-28

Completion date

2013-06-30

Last updated

2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Interleukin 1, Type 1 diabetes mellitus, Rilonacept, Arcalyst

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.

Interventions

DRUGRilonacept

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
Incidence and severity of infection in study participants	7 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026