title: No effect of oral insulin on residual beta-cell function in recent-onset type I diabetes (the IMDIAB VII). IMDIAB Group.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.affiliation: Libera Università Campus Biomedico, Rome, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Pozzilli
authors.forename: D
authors.initials: D
authors.lastname: Pitocco
authors.forename: N
authors.initials: N
authors.lastname: Visalli
authors.forename: M G
authors.initials: MG
authors.lastname: Cavallo
authors.forename: R
authors.initials: R
authors.lastname: Buzzetti
authors.forename: A
authors.initials: A
authors.lastname: Crinò
authors.forename: S
authors.initials: S
authors.lastname: Spera
authors.forename: C
authors.initials: C
authors.lastname: Suraci
authors.forename: G
authors.initials: G
authors.lastname: Multari
authors.forename: M
authors.initials: M
authors.lastname: Cervoni
authors.forename: M L
authors.initials: ML
authors.lastname: Manca Bitti
authors.forename: M C
authors.initials: MC
authors.lastname: Matteoli
authors.forename: G
authors.initials: G
authors.lastname: Marietti
authors.forename: F
authors.initials: F
authors.lastname: Ferrazzoli
authors.forename: M R
authors.initials: MR
authors.lastname: Cassone Faldetta
authors.forename: C
authors.initials: C
authors.lastname: Giordano
authors.forename: M
authors.initials: M
authors.lastname: Sbriglia
authors.forename: E
authors.initials: E
authors.lastname: Sarugeri
authors.forename: G
authors.initials: G
authors.lastname: Ghirlanda
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D017668:Age of Onset; D001786:Blood Glucose / Q000378:metabolism; D002096:C-Peptide / Q000097:blood; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D007515:Islets of Langerhans / Q000187:drug effects / Q000378:metabolism*; D007558:Italy; D008297:Male
chemical_list: D001786:Blood Glucose; D002096:C-Peptide; D006442:Glycated Hemoglobin; D007328:Insulin