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Therapeutic Areas: Endocrinology
Disease Category: Diabetes Mellitus, Type 1

Trial Information

Study of Thymoglobulin to Arrest type 1 diabetes

Type 1 diabetes is a disease caused when an error is made by the body’s immune system, which causes the body to destroy cells in the pancreas that produce insulin. Generally, at the time someone is diagnosed with type 1 diabetes, not all of their insulin-producing cells (known as beta cells) have been destroyed; between 15-40% remain healthy and can still produce insulin. Importantly, it has been shown that preserving even small amounts of beta cells can improve blood sugar control, making daily management of diabetes easier, and reducing the risk of long term complications. Therefore, preserving the function of remaining beta cells in newly onset type 1 diabetes is the goal of the START trial.

The START trial is clinical research study testing whether a drug known as Thymoglobulin® can halt further destruction of beta cells in newly diagnosed type 1 diabetes patients. Thymoglobulin is approved by the U.S. FDA to treat and prevent the rejection of organ transplants. It has been tested in other autoimmune diseases. Several small studies with Thymoglobulin and related drugs in newly diagnosed type 1 diabetes suggest that it may be effective in preserving beta cells.

The START trial is a randomized, placebo-controlled, phase II clinical trial. Participants will be followed for 2 years to assess the safety and efficacy of Thymoglobulin and to perform laboratory measures of their immune system and beta cell function. All participants will receive intensive diabetes management led by the START study team and with the participation of their primary healthcare and current diabetes providers.

People between the ages of 12-35 who were diagnosed with type 1 diabetes within the past 3 months are eligible to participate.

For more information, contact:
Marcia Stanley Wertz, RN, MS, CCRC
Study Coordinator, Pediatric Endocrinology
University of California San Francisco,
Phone: 415-514-3597

Marcia Stanley Wertz, RN, MS, CCRC, Study Coordinator
Immune Tolerance Network
Located in:
San Francisco, CA
Phone: 415-514-3597
EMail: Marcia.Wertz@ucsf.edu

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