A multi-centre randomized trial of two different doses of nicotinamide in patients with recent-onset type 1 diabetes (The IMDIAB VI)

Natalia Visalli, Maria G. Cavallo, Alberto Signore, Marco G. Baroni, Raffaella Buzzetti, Elvira Fioriti, Chiara Mesturino, Rossana Fiori, Lucio Lucentini, Maria C. Matteoli, Antonio Crinò, Stefania Corbi, Sabrina Spera, Carlo Teodonio, Francesco Paci, Rita Amoretti, Luigi Pisano, Concetta Suraci, Giuseppe Multari, Nicoletta SulliMarco Cervoni, Giancarlo De Mattia, Maria R. Cassone Faldetta, Brunetto Boscherini, Maria L. Manca Bitti, Giovanni Marietti, Federica Ferrazzoli, Carla Bizzarri, Dario Pitocco, Giovanni Ghirlanda, Paolo Pozzilli

Research output: Contribution to journalArticlepeer-review


Background. Intensive insulin therapy is the gold standard by which Type 1 diabetes is treated. In addition to this therapy, administration of nicotinamide (NA) can be beneficial. This concept is reinforced by the results of a recent meta-analysis of the use of NA in patients with recent-onset Type 1 diabetes. Methods. In this study we compared two different doses of NA in 74 patients with duration of Type 1 diabetes <4 weeks (mean age 13 years). Patients were randomly allocated in blind to two treatment groups: 38 patients received a dose of 25 mg/kg (b.w.) of NA and 36 patients received a dose of 50 mg/kg (b.w.) of NA. Intensive insulin therapy was carried out in order to optimize metabolic control as soon as possible after diagnosis and to maintain blood glucose level as near to normal as possible. Response to therapy was monitored throughout the study by investigating the occurrence of clinical (complete) remission defined, according to the recommendations of the International Diabetes Immunotherapy Group, as restoration of normal fasting and post-prandial blood glucose without any insulin administration for more than 2 weeks. Moreover, the integrated measures of metabolic control (C-peptide, HbA(1c) and insulin dose) were analysed at 3-month intervals up to 1 year after diagnosis. Results. There were no significant differences in the integrated measures of metabolic control between the two NA treated groups either at onset of the disease or at each 3-month interval up to 1 year after diagnosis, although there was a tendency toward higher insulin dosages in the 50 mg NA group. No significant differences were observed in the rate of clinical remission between the two groups. Conclusion. We conclude that patients with recent-onset Type 1 diabetes treated with two different doses of NA, in addition to intensive insulin therapy, show similar residual beta-cell function 1 year later. Since both doses of NA are likely to be effective in reducing beta-cell dysfunction, the smaller dose of 25 mg/kg NA would be sufficient as a higher dose may induce insulin resistance.

Original languageEnglish
Pages (from-to)181-185
Number of pages5
JournalDiabetes/Metabolism Research and Reviews
Issue number3
Publication statusPublished - May 1999


  • C-peptide secretion
  • Insulin therapy
  • Nicotinamide
  • Type 1 diabetes

ASJC Scopus subject areas

  • Endocrinology
  • Biochemistry
  • Endocrinology, Diabetes and Metabolism


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