| Titre : | Oral insulin administration and residual bêta-cell function in recent-onset type 1 diabetes : a multicentre randomised controlled trial. (2000) |
| Auteurs : | L. CHAILLOUS ; C. ATLAN-GEPNER ; C. BOITARD ; P. BOUGNERES ; B. BOUHANICK ; J.C. CAREL ; B. Charbonnel ; N. Lahlou ; P. LECOMTE ; H. LEFEVRE ; R. MARECHAUD ; A. MOGENET ; M. NICOLINO ; P. SAI ; C. THIVOLET ; Centre Hospitalier Universitaire. Lyon. FRA ; Centre Hospitalier Universitaire. Nantes. FRA ; Centre Hospitalier Universitaire. Paris Necker. FRA ; Centre Hospitalier Universitaire. Paris Saint Vincent de Paul. FRA ; Diabéte Insuline Orale Group. FRA |
| Type de document : | Article |
| Dans : | Lancet (The) (vol. 356, n° 9229, 2000) |
| Pagination : | 545-549 |
| Langues: | Anglais |
| Mots-clés : | Diabète insulinodépendant ; Thérapeutique médicamenteuse ; Prévention santé ; France ; Europe ; Enfant ; Homme ; Adulte ; Glande endocrine [pathologie] ; Immunopathologie ; Maladie autoimmune ; Thérapeutique |
| Résumé : | [BDSP. Notice produite par INIST tR0xw9rS. Diffusion soumise à autorisation]. Background Oral administration of autoantigens can slow the progression of bêta-cell destruction in non-obese diabetic mice. We investigated whether oral administration of recombinant human insulin could protect residual bêta-cell function in recent-onset type 1 diabetes. Methods We enrolled 131 autoantibody-positive diabetic patients aged 7-40 years within 2 weeks of diagnosis (no ketoacidosis at diagnosis, weight loss<10%, polyuria for<6 weeks). They were randomly assigned 2.5 mg or 7.5 mg oral insulin daily or placebo for 1 year, in addition to subcutaneous insulin therapy. Serum C-peptide concentrations were measured in the fasting state and after stimulation, to assess bêta-cell function. Autoantibodies to bêta-cell antigens were assayed. Analyses were by intention to treat. Findings Baseline C-peptide and haemoglobin A1c concentrations were similar in the three groups. During follow-up, there were no differences between the groups assigned 2.5 mg or 7.5 mg oral insulin or placebo in subcutaneous insulin requirements, haemoglobin A1c concentrations, or measurements of fasting (mean at 12 months 0.18 [SD 0.17], 0.17 [0.17], and 0.17 [0.12] nmol/L) or stimulated C-peptide concentrations (glucagon-stimulated 0.39 [0.38], 0.37 [0.39], and 0.33 [0.24] nmol/L ; meal-stimulated 0.72 [0.60], 0.49 [0.49], and 0.57 [0.51 nmol/L]. Neither age nor C-peptide concentration at entry influenced treatment effects. (...) |
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