Low Dose Cyclosporin and Methotrexate Therapy in Diabetes

This study has been completed.
Sponsor:
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00905073
First received: May 19, 2009
Last updated: April 12, 2011
Last verified: May 2009
  Purpose

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


Condition Intervention
Type 1 Diabetes Mellitus
Drug: cyclosporin and methotrexate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Dose Cyclosporin and Methotrexate Therapy in New Onset Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • insulin dose [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • renal function [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: February 1990
Study Completion Date: June 1994
Primary Completion Date: June 1994 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

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

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00905073

Locations
United States, District of Columbia
Georgetown University
Washington DC, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Douglas Sobel, MD Georgetown University
  More Information

No publications provided

Responsible Party: Douglas Sobel, Georgetown University
ClinicalTrials.gov Identifier: NCT00905073     History of Changes
Other Study ID Numbers: 10988
Study First Received: May 19, 2009
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
type 1 diabetes mellitus
cyclosporin
methotrexate
renal function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Cyclosporins
Cyclosporine
Methotrexate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014