A Randomized Trial of Methotrexate in Newly Diagnosed Patients with Type 1 Diabetes Mellitus

The aim of this study was to determine whether low-dose, oral methotrexate therapy would prolong the remission phase at the onset of Type 1 diabetes. Ten newly diagnosed, nonacidotic, ICA-positive, Type 1 diabetics were randomly assigned to receive either methotrexate (5 mg/m2/week) or no immunosupp...

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Published inClinical immunology (Orlando, Fla.) Vol. 96; no. 2; pp. 86 - 90
Main Authors Buckingham, Bruce A., Sandborg, Christy I.
Format Journal Article
LanguageEnglish
Published San Diego, CA Elsevier Inc 01.08.2000
Elsevier
Subjects
Adolescent
Biological and medical sciences
c-peptide
C-Peptide - metabolism
Child
Diabetes Mellitus, Type 1 - drug therapy
Dose-Response Relationship, Drug
Female
Glycated Hemoglobin A - metabolism
honeymoon
Humans
Immunomodulators
Insulin - metabolism
Liver - physiology
Male
Medical sciences
methotrexate
Methotrexate - adverse effects
Methotrexate - therapeutic use
Pharmacology. Drug treatments
remission
type 1 diabetes mellitus
c-peptide
type 1 diabetes mellitus
methotrexate
honeymoon
remission
Endocrinopathy
Antifolate
Human
Chemotherapy
Treatment
Antimetabolic
Diabetes mellitus
Treatment efficiency
Early stage
Immunosuppressive agent
Methotrexate
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Summary:The aim of this study was to determine whether low-dose, oral methotrexate therapy would prolong the remission phase at the onset of Type 1 diabetes. Ten newly diagnosed, nonacidotic, ICA-positive, Type 1 diabetics were randomly assigned to receive either methotrexate (5 mg/m2/week) or no immunosuppressive treatment. The study was not blinded and no placebo was given. Endogenous insulin production was assessed every 3 months by fasting and Sustacal-stimulated C-peptide levels. Methotrexate therapy was not beneficial in prolonging islet survival as assessed by fasting and stimulated C-peptide levels. Insulin requirements were generally lower in the control group, and islet failure, determined by an insulin requirement of >0.7 u/kg/day, occurred earlier for those receiving MTX (P < 0.02). Side effects of methotrexate treatment were minimal. There was no benefit from methotrexate therapy, and methotrexate therapy was associated with an earlier increase in insulin requirements.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
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ISSN:1521-6616
1521-7035
DOI:10.1006/clim.2000.4882