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

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.

• Authors: 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
• Journal: Diabetologia (Diabetologia) Vol. 43 Issue 8 Pg. 1000-4 (Aug 2000) ISSN: 0012-186X [Print] Germany
• PMID: 10990077 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Glucose
• C-Peptide
• Glycated Hemoglobin A
• Insulin

Topics

• Administration, Oral
• Adolescent
• Adult
• Age of Onset
• Blood Glucose (metabolism)
• C-Peptide (blood)
• Child
• Diabetes Mellitus, Type 1 (blood, drug therapy)
• Double-Blind Method
• Female
• Glycated Hemoglobin (analysis)
• Humans
• Injections, Subcutaneous
• Insulin (administration & dosage, therapeutic use)
• Islets of Langerhans (drug effects, metabolism)
• Italy
• Male