Double-blind controlled trial of azathioprine in children with newly diagnosed type I diabetes

Abstract

A double-blind controlled trial of azathioprine (2 mg·kg-1·day-1) was conducted with 49 patients aged 2-20 yr (mean 10.8 yr) who had newly diagnosed type I (insulin-dependent) diabetes. Patients were randomly assigned to receive either azathioprine (n = 24) or placebo (n = 25) for 12 mo, beginning within the 20-day period after diagnosis. Baseline clinical and metabolic characteristics did not differ between the two groups. No patient experienced complete remission, defined as restoration of normal carbohydrate tolerance without other treatment. Partial remission, defined as good metabolic control (hemoglobin A(1c) ≤7.9%, preprandial blood glucose ≤8 mM with an insulin dose of <0.5 U·kg-1·da..