ABSTRACT
The natural history of Insulin dependent diabetes (IDD) includes a long preclinical phase in which autoimmune destruction of pancreatic beta cells usually occurs. Azathioprine is a purine antagonist that affects delayed immunological hypersensitivity and cellular cytotoxicity. The potential oncogenic effects of immunosuppressive agents in general, and of azathioprine in particular, is one of the major deterrents to their use in trials of newly diagnosed diabetes. Patients were admitted into the study only if they had findings consistent with an autoimmune etiology for their IDD. Complete blood counts were performed every 2 weeks for 6 months, then monthly, to monitor the effects of azathioprine therapy. Trials of immunotherapy for IDD should be pursued only in a research setting using randomized study designs with as much blinding as possible. Investigators who have been involved in such studies have been uniformly impressed that more control patients develop natural remissions than they would have suspected based upon their previous experiences.
