Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cyclosporin and methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes mellitus, cyclosporin, methotrexate, renal function
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
Sites / Locations
- Georgetown University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cyclosporin+Methotrexate
Arm 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.
Outcomes
Primary Outcome Measures
insulin dose
Secondary Outcome Measures
renal function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00905073
Brief Title
Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
Official Title
Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
February 1990 (undefined)
Primary Completion Date
June 1994 (Actual)
Study Completion Date
June 1994 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Georgetown University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
type 1 diabetes mellitus, cyclosporin, methotrexate, renal function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cyclosporin+Methotrexate
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
cyclosporin and methotrexate
Intervention Description
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.
Primary Outcome Measure Information:
Title
insulin dose
Time Frame
one year
Secondary Outcome Measure Information:
Title
renal function
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Sobel, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington DC
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
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