Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
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|ClinicalTrials.gov Identifier: NCT00905073|
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : April 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: cyclosporin and methotrexate||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus|
|Study Start Date :||February 1990|
|Actual Primary Completion Date :||June 1994|
|Actual Study Completion Date :||June 1994|
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.
- insulin dose [ Time Frame: one year ]
- renal function [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905073
|United States, District of Columbia|
|Washington DC, District of Columbia, United States, 20007|
|Principal Investigator:||Douglas Sobel, MD||Georgetown University|