Type 1 Diabetes Mellitus Clinical Trial
Official title:
Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus
The purpose of this study is to determine whether treatment with low dose cyclosporin and methotrexate can inhibit the development of new onset diabetes mellitus
Objective: Although high doses of cyclosporin (cyclo) inhibits the development of type 1
diabetes mellitus, its usefulness is limited by its toxicity. Since methotrexate (mtx) and
cyclo synergistically inhibit other disease processes, we hypothesized that low dose cyclo
and mtx therapy could safely induce remission.
Research Design and Methods: In an open pilot study, insulin dose and glycemic control will
be compared in children with new onset Type 1 diabetes administered cyclo at 7.5 mg/kg/day
for 6 weeks and then 4 mg/kg/day and mtx 5 mg/kg/day for one year with control children.
After 6 weeks, doses were adjusted to maintain blood cyclo levels to 100-200 ng/ml.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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