A randomized trial of methotrexate in newly diagnosed patients with type 1 diabetes mellitus

Clin Immunol. 2000 Aug;96(2):86-90. doi: 10.1006/clim.2000.4882.

Abstract

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/m(2)/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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • C-Peptide / metabolism
  • Child
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Dose-Response Relationship, Drug
  • Female
  • Glycated Hemoglobin A / metabolism
  • Humans
  • Insulin / metabolism
  • Liver / physiology
  • Male
  • Methotrexate / adverse effects
  • Methotrexate / therapeutic use*

Substances

  • C-Peptide
  • Glycated Hemoglobin A
  • Insulin
  • Methotrexate