Diabetologia

, Volume 43, Issue 8, pp 1000–1004

No effect of oral insulin on residual beta-cell function in recent-onset Type I diabetes (the IMDIAB VII)

  • P. Pozzilli
  • D. Pitocco
  • N. Visalli
  • M. G. Cavallo
  • R. Buzzetti
  • A. Crinò
  • S. Spera
  • C. Suraci
  • G. Multari
  • M. Cervoni
  • M. L. Manca Bitti
  • M. C. Matteoli
  • G. Marietti
  • F. Ferrazzoli
  • M. R. Cassone Faldetta
  • C. Giordano
  • M. Sbriglia
  • E. Sarugeri
  • G. Ghirlanda
  • and the IMDIAB Group
Rapid communication

DOI: 10.1007/s001250051482

Cite this article as:
Pozzilli, P., Pitocco, D., Visalli, N. et al. Diabetologia (2000) 43: 1000. doi:10.1007/s001250051482

Abstract

Aims/hypothesis. Induction of tolerance to insulin is achievable in animal models of Type I (insulin-dependent) Diabetes mellitus by oral treatment with this hormone, which can lead to prevention of the disease. In the Diabetes Prevention Trial of Type I diabetes (DPT-1), oral insulin is given with the aim of preventing disease insurgence. We investigated whether if given at diagnosis of Type I diabetes in humans, oral insulin can still act as a tolerogen and therefore preserve residual beta-cell function, which is known to be substantial at diagnosis. Methods. A double-blind trial was carried out in patients (mean age ± SD: 14 ± 8 years) with recent-onset Type I diabetes to whom oral insulin (5 mg daily) or placebo was given for 12 months in addition to intensive subcutaneous insulin therapy. A total of 82 patients with clinical Type I diabetes ( < 4 weeks duration) were studied. Basal C peptide and glycated haemoglobin were measured and the insulin requirement monitored every 3 months up to 1 year. Insulin antibodies were also measured in 27 patients treated with oral insulin and in 18 patients receiving placebo at the beginning of the trial and after 3, 6 and 12 months of treatment. Results. The trial was completed by 80 patients. Overall and without distinction between age at diagnosis, at 3, 6, 9 and 12 months baseline mean C-peptide secretion in patients treated with oral insulin did not differ from that of those patients treated with placebo. In patients younger than 15 years a tendency for lower C-peptide values at 9 and 12 months was observed in the oral insulin group. Insulin requirement at 1 year was similar between the two groups as well as the percentage of glycated haemoglobin. Finally, IgG insulin antibodies were similar in the two groups at each time point. Conclusion/interpretation. The results of this study indicate that the addition of 5 mg of oral insulin does not modify the course of the disease in the first year after diagnosis and probably does not statistically affect the humoral immune response against insulin. [Diabetologia (2000) 43: 1000–1004]

Keywords Type I diabetes oral insulin insulin antibodies prevention. 
Download to read the full article text

Copyright information

© Springer-Verlag Berlin Heidelberg 2000

Authors and Affiliations

  • P. Pozzilli
    • 1
  • D. Pitocco
    • 1
  • N. Visalli
    • 1
  • M. G. Cavallo
    • 1
  • R. Buzzetti
    • 1
  • A. Crinò
    • 1
  • S. Spera
    • 1
  • C. Suraci
    • 1
  • G. Multari
    • 1
  • M. Cervoni
    • 1
  • M. L. Manca Bitti
    • 1
  • M. C. Matteoli
    • 1
  • G. Marietti
    • 1
  • F. Ferrazzoli
    • 1
  • M. R. Cassone Faldetta
    • 1
  • C. Giordano
    • 2
  • M. Sbriglia
    • 2
  • E. Sarugeri
    • 3
  • G. Ghirlanda
    • 1
  • and the IMDIAB Group
  1. 1.Rome, ItalyIT
  2. 2.Medical Clinic, University of Palermo, Palermo, ItalyIT
  3. 3.San Raffaele Scientific Institute, University of Milan, Milan, ItalyIT