Low Dose Cyclosporin and Methotrexate Therapy in Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905073
• Other study ID #: 10988
• Status: Completed
• Phase: N/A
• First received: May 19, 2009
• Last updated: April 12, 2011
• Start date: February 1990
• Est. completion date: June 1994

Study information

• Verified date: May 2009
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 1994
• Est. primary completion date: June 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Georgetown University	Washington DC	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin dose		one year	No
Secondary	renal function		one year	Yes