Double blind trial of nicotinamide in recent-onset IDDM (the IMDIAB III study) (original) (raw)

Summary

Nicotinamide has been recently introduced, in addition to intensive insulin therapy for patients with recent-onset insulin-dependent diabetes mellitus (IDDM) to protect beta cells from end-stage destruction. However, available data are conflicting. A double blind trial in 56 newly-diagnosed IDDM patients receiving nicotinamide for 12 months at a dose of 25 mg/kg body weight or placebo was designed in order to determine whether this treatment could improve the integrated parameters of metabolic control (insulin dose, glycated haemoglobin and C-peptide secretion) in the year after diagnosis. In addition to nicotinamide or placebo, patients received three to four insulin injections daily to optimize blood glucose levels. Patients treated with nicotinamide or placebo received similar doses of insulin during follow-up and 1 year after diagnosis with comparable glycated haemoglobin levels (6.7±1.8 % nicotinamide vs 7.1±0.6 % placebo). Basal and glucagon stimulated C-peptide secretion detectable at diagnosis were similarly preserved in the course of 12 months follow-up both in nicotinamide and placebo treated patients. No adverse effects were observed in patients receiving nicotinamide. When age at diagnosis was taken into account, nicotinamide treated older patients ( > 15 years of age) showed significantly higher stimulated C-peptide secretion than placebo treated patients (p < 0.02). These results suggest that nicotinamide can preserve and improve stimulated beta-cell function only in patients diagnosed after puberty. We conclude that in these patients nicotinamide can be added to insulin at the time of disease diagnosis to maintain and possibly improve residual beta-cell function. However, further studies on patients diagnosed after puberty are needed to confirm whether nicotinamide can be considered an additional tool to insulin in early-onset IDDM.

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Authors and Affiliations

  1. The IMDIAB Study Group, Rome, Italy
    P. Pozzilli, N. Visalli, A. Signore, M. G. Baroni, R. Buzzetti, M. G. Cavallo, M. L. Boccuni, D. Fava, C. Gragnoli, D. Andreani, L. Lucentini, M. C. Matteoli, A. Crinò, C. A. Cicconetti, C. Teodonio, E. Paci, R. Amoretti, L. Pisano, M. G. Pennafina, G. Santopadre, G. Marozzi, G. Multari, M. A. Suppa, L. Campea, G. C. De Mattia, M. Cassone Faldetta, G. Marietti, F. Perrone, A. V. Greco & G. Ghirlanda

Authors

  1. P. Pozzilli
  2. N. Visalli
  3. A. Signore
  4. M. G. Baroni
  5. R. Buzzetti
  6. M. G. Cavallo
  7. M. L. Boccuni
  8. D. Fava
  9. C. Gragnoli
  10. D. Andreani
  11. L. Lucentini
  12. M. C. Matteoli
  13. A. Crinò
  14. C. A. Cicconetti
  15. C. Teodonio
  16. E. Paci
  17. R. Amoretti
  18. L. Pisano
  19. M. G. Pennafina
  20. G. Santopadre
  21. G. Marozzi
  22. G. Multari
  23. M. A. Suppa
  24. L. Campea
  25. G. C. De Mattia
  26. M. Cassone Faldetta
  27. G. Marietti
  28. F. Perrone
  29. A. V. Greco
  30. G. Ghirlanda

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Pozzilli, P., Visalli, N., Signore, A. et al. Double blind trial of nicotinamide in recent-onset IDDM (the IMDIAB III study).Diabetologia 38, 848–852 (1995). https://doi.org/10.1007/s001250050362

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