Trial | NCT00905073  Report issue

Title

Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    8
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.
Study Started
Feb 28
1990
Primary Completion
Jun 30
1994
Study Completion
Jun 30
1994
Last Update
Apr 13
2011
Estimate

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.

cyclosporin+Methotrexate Experimental

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.

Criteria 

Inclusion Criteria:

Diagnosis of Type1 diabetes mellitus and be obtaining insulin therapy for less than 4 weeks

Exclusion Criteria:

Ketoacidosis
Body weight over 110% of ideal weight
Condition where immunosuppression is contraindicated
Abnormal liver or renal function tests
No Results Posted