Low Dose Cyclosporin and Methotrexate Therapy in Diabetes

NCT ID: NCT00905073

Last Updated: 2011-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1990-02-28
• Study Completion Date: 1994-06-30

Brief 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

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cyclosporin+Methotrexate

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.

Group Type: EXPERIMENTAL

cyclosporin and methotrexate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Georgetown University

Principal Investigators

Douglas Sobel, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

10988

Identifier Type: -

Identifier Source: org_study_id