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OpenTrials
Completed

NCT Number: NCT00962026

Rilonacept in Diabetes Mellitus Type 1: Safety Study

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Medical Center

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rilonacept

Drug

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

Other names: Arcalyst, IL-1 Trap

Primary outcomes

  1. Incidence and severity of infection in study participants

    Time frame: 7 months

Secondary outcomes

  1. Incidence and severity of other adverse effects in study participants

    Time frame: 7 months

  2. Changes in participants' sex steroids (testosterone/estradiol)

    Time frame: 7 months

  3. Changes in participants' HbA1c levels, insulin doses, and beta cell preservation

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: RID-A

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 19, 2009
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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