Rilonacept in Type 1 Diabetes

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To find out more about the Rilonacept in Type 1 Diabetes study, or to see if you qualify to join, contact:

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Information for those who have been asked to participate:

Why is this study being done?

Type 1 diabetes develops when your body loses its ability to make enough insulin, a protein that helps your body use the energy from the food you eat, especially from carbohydrates like sugar.  In type 1 diabetes, your immune system mistakenly attacks those cells in your body which make insulin (called beta cells).  Modifying this attack might slow the progression of Type 1 diabetes.

Click here or here to learn more about Type 1 diabetes.

What does Rilonacept have to do with Type 1 Diabetes?

  • The immune attack on beta cells may be controlled in part by a chemical called interleukin-1 beta (IL-1beta).  Blocking this chemical may have benefits for people with diabetes.
  • This study is being done to see if rilonacept, which binds and traps IL-1 beta, is safe to use in patients with type 1 diabetes, and 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. 
  • Rilonacept has been approved by the U.S. Food and Drug Administration (FDA) to treat persons over 12 years of age with certain types of inflammation called cryopyrin-associated periodic syndromes (CAPS),

Click here to read a scientific article about how IL-1 (and related chemicals) attack beta cells.

Click here to learn more about Rilonacept.

Why is this research?

  • Rilonacept has not been approved by the FDA for the treatment of type 1 diabetes.
  • This is a phase 1, open-label study. This means that rilonacept is being newly tested in people diagnosed with type 1 diabetes,  and that all volunteers who participate in this study will receive rilonacept during the study.

Click here to learn more about clinical research in general.

Who can join this study?

To take part in this study, you must:

  • Be diagnosed with type 1 diabetes in the past 5 years
  • Be 16 to 45 years old
  • Be taking insulin
  • Not be taking any inhaled or oral steroids (for example: Advair, Orapred)
  • Not be taking any other experimental medication within the last 28 days or while on this study
  • Not have any ongoing infections or infectious diseases (for example: Hepatitis, HIV)

This study will enroll up to 15 volunteers. Each volunteer’s participation will last approximately 7 months. Study procedures will take place at Children’s Medical Center Dallas and UT Southwestern Medical Center.

What will I (or my child) be asked to do if I am on this study?

  • Give consent for the study
  • Have blood and urine tests to see if you qualify for the study
  • Receive weekly injections of the investigational drug for 6 months. The first injection is observed in our clinic; the rest may be given by the study volunteer at home.
  • Attend up to 6 follow up visits in person and 8 telephone calls during the 7 month study commitment
  • Have blood and urine tests at follow up visits while taking the investigational drug

Why should I (or my child) consider joining this study?

If you agree to take part in this study, there may or may not be direct benefits to you. It is possible that rilonacept may improve your diabetes, but this may not occur. The researchers cannot  guarantee that you will benefit from participation in this research.

We hope the information learned from this study will benefit others with type 1 diabetes in the future. Information gained from this research could lead to improved medical care for them. You will need to weigh the risk of taking the investigational drug against the possible benefits of taking part in this study.

Those who join this study will receive, at no cost, study-related:

  • Close monitoring of their type 1 diabetes
  • Physical exams
  • Direct access to doctors or nurses to answer questions and concerns
  • Blood work
  • Investigational drug