Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus|
- insulin dose [ Time Frame: one year ] [ Designated as safety issue: No ]
- renal function [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 1990|
|Study Completion Date:||June 1994|
|Primary Completion Date:||June 1994 (Final data collection date for primary outcome measure)|
cyclosporin treatment at 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for on year and methotrexate 5 mg/kg/day for one year.
Drug: cyclosporin and methotrexate
cyclosporin 7.5 mg/kg/day for 6 weeks and then 4 mg/kg/day for one year and methotrexate 5 mg/kg/day for one year. After 6 weeks, cyclosporin doses will adjusted to maintain blood cyclo levels to 100-200 ng/ml.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905073
|United States, District of Columbia|
|Washington DC, District of Columbia, United States, 20007|
|Principal Investigator:||Douglas Sobel, MD||Georgetown University|