Sanford Health is among the first sites to offer the EXTEND trial, a clinical trial that will test the ability of the drug tocilizumab to slow disease progression and help maintain natural insulin production in individuals with newly diagnosed type 1 diabetes.
Type 1 diabetes is the focus of The Sanford Project, a cornerstone research initiative at Sanford Research.
Individuals with type 1 diabetes, an autoimmune disease, experience a loss of insulin-producing beta cells. Tocilizumab is an antibody that targets the interleukin-6 receptor, which plays a role in inflammation and autoimmunity. The study will evaluate whether the drug can restore the body’s immune balance in a way that helps preserve remaining beta cells.
Tocilizumab is FDA-approved for treatment of rheumatoid arthritis andjuvenile idiopathic arthritis, other autoimmune diseases, as young as 2 years of age.
“Because the drug used in this clinical trial, tocilizumab, has shown long-lasting improvements in other autoimmune diseases, our hypothesis is that a similar response might be possible for people who were recently diagnosed with type 1 diabetes,” said Kurt Griffin, M.D., Ph.D., director of clinical trials for the Sanford Project.
The EXTEND trial will enroll adults age 18 to 45 years old who have been diagnosed with diabetes within the previous three months. Women who are pregnant or plan to get pregnant in the next two years cannot enroll. Participants will receive study treatment for six months at no cost. Insulin production will be measured using mixed meal tolerance tests, with the final assessment at two years.
EXTEND is conducted by the Immune Tolerance Network in collaboration with Type 1 Diabetes TrialNet and is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which are NIH funded.
About Sanford Health
Sanford Health is an integrated health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 43 hospitals and nearly 250 clinics in nine states and three countries. Sanford Health’s 27,000 employees, including 1,400 physicians, make it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford have allowed for several initiatives, including global children’s clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. For more information, visit sanfordhealth.org.
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