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Clinical Trial of a New Immunosuppresive Agent

Columbia University is recruiting subjects for a trial of a new immune suppressive agent for treatment of new onset Type 1 diabetes mellitus. Although studies over the past two decades have provided a great deal of information about the role of the immune system in the pathogenesis of diabetes, at this time, there is no treatment for Type 1 diabetes other than insulin. The new agent to be tested is a modified form of a drug used in clinical practice, that does not have the side effects and toxicities that have prevented the use of other immune suppressive agents. The drug has a mechanism of action that is different from those tested previously in patients with diabetes and its application in diabetes is based on current understanding of the mechanism of the disease. In animal models of Type 1 diabetes, the agent was able to reverse diabetes at the time of clinical presentation with hyperglycemia, without recurrence of the disease after the agent was stopped.

The study will be conducted by Dr. Kevan Herold at the Naomi Berrie Diabetes Center at Columbia Presbyterian Medical Center in New York. The trial will involve admission to the hospital while the drug is given. The clinical care of the patient will be maintained by the patients own physician, and any referred patients will be referred back to their own physician for medical care. There is no charge for this study.

The investigator holds an IND from the FDA for this trial in patients with Type 1 diabetes. The trial has been approved by the Institutional Review Board at Columbia University.

We are initially looking for patients over the age of 13 years of age (but will expand to patients as young as 8 years of age) who are within 6 weeks of diagnosis of Type 1 diabetes. For information, please contact Dr. Herold at kh318@columbia.edu or by phone at (212) 304-5492.