Combination of nicotinamide and steroid versus nicotinamide in recent-onset IDDM: The IMDIAB II study

P. Pozzilli, N. Visalli, M. L. Boccuni, M. G. Baroni, R. Buzzetti, E. Fioriti, A. Signore, M. G. Cavallo, D. Andreani, L. Lucentini, M. C. Matteoli, A. Crinò, C. A. Cicconetti, C. Teodonio, R. Amoretti, L. Pisano, M. G. Pennafina, G. Santopadre, G. Marozzi, G. MultariL. Campea, M. A. Suppa, G. G. De Mattia, M. Cassone Faldetta, G. Marietti, F. Perrone, A. V. Greco, G. Ghirlanda

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVE - The aim of this study was to compare the effect of nicotinamide (NCT) alone or in combination with a cortisone-like substance, deflazacort (DFL), on the integrated parameters of metabolic control in patients with the recent-onset of insulin-dependent diabetes mellitus (IDDM). RESEARCH DESIGN AND METHODS - Thirty-six patients who were diagnosed with diabetes between 5 and 35 years of age entered a randomized, double-blind, 1-year prospective study. Group A (n = 18) received NCT for 1 year (25 mg · kg-1 · day-1) plus DFL for 3 months (0.6 mg · kg-1 · day-1 in the first month, 0.3 mg · kg-1 · day-1 in the other 2 months). Group B (n = 18) received NCT for 1 year (25 mg · kg-1 · day-1) plus placebo for the first 3 months. All patients were treated with intensified insulin therapy. RESULTS - At 3 months after diagnosis, the insulin dose was significantly higher in group A compared with group B (P <0.03) with similar HbA1 levels. Basal and stimulated C-peptide levels in group A of both adults and children were significantly higher compared with patients of group B (P <0.05 and P <0.03, respectively). At the end of a 1-year follow-up, basal C-peptide did not differ between the two groups, although stimulated C-peptide was still significantly higher in patients of group A compared with group B (P <0.05). Finally, insulin requirement did not differ between the two groups. CONCLUSIONS - A short-term course of DFL therapy at diagnosis in addition to NCT slightly increases glucagon-stimulated but not basal β-cell function after 1 year.

Original languageEnglish
Pages (from-to)897-900
Number of pages4
JournalDiabetes Care
Volume17
Issue number8
Publication statusPublished - Aug 1994

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine

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