Immune Tolerance Network   A clinical research consortium sponsored by NIAID and JDRF
START logoA clinical research study of thymoglobulin to arrest type 1 diabetes


 

What is the START trial?

The healthy insulin-producing beta cells that you have left when you are first diagnosed with type 1 diabetes are precious indeed. The aim of the START trial is to stop the immune system from attacking these remaining beta cells, so that they may continue to produce insulin.

START is enrolling 66 new onset diabetes patients – those up to 3 months from diagnosis – at 8 clinical centers in the United States.

Read the JDRF Frontline article on the research that spawned the START Trial.

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The medication being tested in the START trial is called Thymoglobulin®, which works on white blood cells known as T cells. T cells are key players in the immune system’s mistaken attack on the insulin-producing cells that is the cause of type 1 diabetes. Thymoglobulin may work in at least two ways - by eliminating the destructive T cells from the bloodstream, or by changing how the remaining T cells work. The START trial is testing whether Thymoglobulin can ‘reset’ the immune system, so that the remaining T cells (or the new T cells that grow back) learn to accept the beta cells, rather than continue to attack them.

While Thymoglobulin has been approved by the FDA to treat and prevent the rejection of organ transplants, it is considered an experimental therapy for type 1 diabetes. Several small studies with Thymoglobulin and similar drugs suggest that it may help protect beta cells, and have been used to treat other autoimmune diseases, including multiple sclerosis, rheumatoid arthritis, lupus and others.

As with any medication, there is a risk of developing side effects. Depending on the person, side effects can vary in both type and severity. The most common side effects experienced after taking Thymoglobulin are moderate fever, chills, and joint pain. More serious side effects have been reported only rarely after Thymoglobulin treatment. For this reason, you will be given the drug in the hospital under medical supervision. Before you decide if you would like to participate, trial staff will discuss all potential risks and benefits with you.

 

Recruitment is now closed.

For information on additional ITN trials for people recently diagnosed with type 1 diabetes, please visit:

Retain Study
www.retainstudy.org

T1DAL Study
www.t1dal.org

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Downloads

START Brochure (871 kb)

FAQ (438 kb)

Physician Reference Card (154 kb)

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