Rilonacept in Diabetes Mellitus Type 1: Safety Study
RID-A
A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 24, 2014
February 1, 2014
2.1 years
August 4, 2009
February 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of infection in study participants
7 months
Secondary Outcomes (3)
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
Study Arms (1)
Rilonacept
EXPERIMENTALInterventions
Rilonacept given subcutaneously, dose per package labeling, once weekly.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Medical Center
Dallas, Texas, 75235, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Perrin C White, MD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Pediatric Endocrinology
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 19, 2009
Study Start
February 1, 2011
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
February 24, 2014
Record last verified: 2014-02