Low Dose Cyclosporin and Methotrexate Therapy in Diabetes

Georgetown University

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: cyclosporin and methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT00905073

10988 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 1 patient group

cyclosporin+Methotrexate

Experimental group

Description:

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.

Treatment:

Drug: cyclosporin and methotrexate