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,
- MG 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 Multari,
- L Campea,
- M A Suppa,
- G C De Mattia,
- M Cassone Faldetta,
- G Marietti,
- F Perrone,
- A V Greco and
- G Ghirlanda
- Address correspondence and reprint requests to Paolo Pozzilli, MD, Endocrinologia(I), II Clinica Medica, Policlinico Umberto I, 00161 Rome, Italy.
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 forthe 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.
- Received August 20, 1993.
- Accepted March 24, 1994.
- Copyright © 1994 by the American Diabetes Association











