U of M begins clinical trials for type 1 diabetes

Multi-center study will help determine whether islet transplantation becomes an FDA-approved treatment

MINNEAPOLIS / ST. PAUL (May 8, 2008)—Researchers at the University of Minnesota’s Diabetes Institute for Immunology and Transplantation announce the start of new clinical trials for people with type 1 diabetes. The University is one of only seven sites in the United States funded by the National Institutes of Health as part of the Clinical Islet Transplantation Consortium, the goal of which is to determine whether islet transplantation becomes an FDA-approved treatment for people with difficult-to-manage type 1 diabetes.

Islet transplantation, which involves isolating islet cells from a donor pancreas and transplanting them into the liver, seeks to address an unmet medical need for people with type 1 diabetes who suffer from hypoglycemic unawareness, or the inability to sense when blood sugar is low.   If islet transplantation is successful, the transplanted islets will sense blood glucose levels on a minute-to-minute basis and release the appropriate amount of insulin to achieve tight blood glucose control; the result is the islet recipient may no longer need to take insulin injections. It also offers hope in reducing the risk of developing debilitating secondary complications of diabetes, such as damage to the heart and blood vessels, eyes, nerves, and kidneys.

At this time, the only people to receive islet transplants are those who are part of a research clinical trial.  Since 2000, the University has completed four clinical trials of islet transplantation in 26 people. Protection from hypoglycemia has been immediate post-transplant, and more than 80 percent of recipients remain protected from severe hypoglycemia five years post-transplant.  About 90 percent of recipients have become insulin-independent post-transplant, and more than 50 percent have maintained insulin independence at five-year follow-up.  These results are comparable to outcomes previously only attainable by whole organ pancreas transplantation.

“The University of Minnesota has long been a leader in islet transplantation for type 1 diabetes,” said Bernhard Hering, M.D., primary investigator for the University of Minnesota studies. “As we recruit individuals suffering from type 1 diabetes to take part in these crucial trials, we have the opportunity to help determine whether this experimental treatment becomes more widely available.”

The clinical trials will involve islet transplantation with a combination of medications to protect and prolong the function of the newly transplanted insulin-producing cells.  People with type 1 diabetes who have had a kidney transplant may also be eligible for an islet transplant as part of these studies.

For more information about the studies and requirements for participating, visit the Diabetes Institute for Immunology and Transplantation at www.diabetesinstitute.org or call 612-626-3016.

Media Contacts:

Sara E. Buss, Academic Health Center, 612-626-7037
Laura Stroup, Academic Health Center, 612-624-5680

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