A Unique JDRF-funded Clinical Trial with TUDCA
Could Improve Insulin Secretion in New-onset TID

Robin Goland, MD, J. Merrill Eastman Professor of Clinical Diabetes and Co-Director of the Berrie Center, is the principal investigator on a new, JDRF-funded clinical trial of a drug TUDCA that could improve beta cell function in people recently diagnosed with type 1 diabetes (T1D). Rudy Leibel, MD, Christopher J. Murphy Professor of Diabetes Research and Co-Director of the Berrie Center and Dieter Egli, PhD, Maimonides Professor of Diabetes Research, are study co-investigators.

Until recently, much of type 1 diabetes research has focused on suppressing the autoimmune system to prevent or reverse T1D. Now scientists are learning that a stress response in the insulin producing beta cell itself also plays a significant role in the development of the disease.

Specifically, stress on the endoplasmic reticulum, (ER), the structure within the beta cell that folds and packages insulin from its precursor form, can lead to the dysfunction and ultimate loss of beta cells. It was recently discovered that the oral drug TUDCA (formally identified as tauroursodeoxycholic acid), approved for use in Europe, used in the treatment of liver disease, can alleviate ER stress.  When TUDCA was given to mice in the early stages of T1D, a reduction of diabetes was observed.

This newly launched pilot study will determine whether TUDCA can preserve insulin secretion in adult patients (age 18-45) with new onset T1D (within first 100 days of diagnosis). If this pilot study is promising, a larger multi-center study of new-onset T1D patients will be done.  Future studies will also be considered for people with pre-T1D, those who have 2 or more pancreatic autoantibodies but normal glucose tolerance, to examine if TUDCA can help prevent T1D.

“There is a lot of reason for hope and optimism in the field of T1D research,” said Dr. Goland, “The knowledge is exploding. There’s a lot of great science that is being applied that is moving us closer toward prevention and cure of T1D.”

For more information about the New-onset T1D TUDCA Trial, contact Ellen Greenberg at 212-851-5425 or emg25@columbia.edu. Please click here to read the JDRF news release about the TUDCA trial. To see an interview with Dr. Goland, click here.