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Appearing in this issue of Diabetes Care is an article by Rakotoambinina et al. (1) documenting the absence of an effect of therapy with cyclosporin A in the progression of /3-cell destruction in a group of seven young adults with biochemically unequivocal, but clinically asymptomatic, diabetes. The study was neither placebo-controlled nor randomized, although there were seven similar subjects who remained untreated. All 14 subjects progressed to overt diabetes under observation. Earlier studies with cyclosporin documented that when given at the time of diagnosis, cyclosporin was associated with an increased frequency and duration of clinical remission (2-5). However, invariably, this /3-cell protective effect was lost, and complete insulin deficiency soon followed. The development of renal complications provided additional evidence that this approach was ill-advised. Many investigators have concluded that at the time of clinical diagnosis of insulin-dependent diabetes mellitus (IDDM), /3-cell damage is so extensive that no intervention strategies are likely to be successful. This observation has moved the investigative spotlight to much earlier in the time course of immune destruction. The present study is an intermediate step back in the immune process. The seven patients were asymptomatic but clearly diabetic by diagnostic standards. Cyclosporin therapy had no detectable effect on the progressive course of j8-cell destruction. The report of Rakotoambinina et al. (1) adds further evidence that immune intervention at the time of diagnosis of diabetes has little chance of success. In 1990, Upton et al. (6) critiqued the five then-active cyclosporin trials and raised serious concerns about the inadequacy of study design, power calculation, patient numbers, and documentation of complications, both shortand longterm. Those admonitions have gone largely unnoticed. Traditionally, medical research advances have been the product of the

Is It Time to Draw the Curtain on Immune Intervention Trials in Newly Diagnosed Patients With IDDM?