Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
Information source: Georgetown University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes Mellitus
Intervention: cyclosporin and methotrexate (Drug)
Phase: N/A
Status: Completed
Sponsored by: Georgetown University Official(s) and/or principal investigator(s): Douglas Sobel, MD, Principal Investigator, Affiliation: Georgetown University
Summary
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
Clinical Details
Official title: Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: insulin dose
Secondary outcome: renal function
Detailed description:
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.
Eligibility
Minimum age: 8 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Georgetown University, Washington DC, District of Columbia 20007, United States
Additional Information
Starting date: February 1990
Last updated: April 12, 2011
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