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.
Article PDF
Similar content being viewed by others
Abbreviations
- NA:
-
Nicotinamide
References
Pozzilli P, Andreani D (1993) Nicotinamide, a vitamin with a potential to prevent type 1 diabetes. Diab Metab Rev 9: 219–239
Pociot F, Reimers JI, Andersen HU (1993) Nicotinamide - biological actions and therapeutic potential in diabetes prevention. Diabetologia 36: 574–576
Kallman B, Burkart U, Krancke KD, Koib-Bachofen V, Kolb H (1992) Toxicity of chemical-generated nitric oxide towards pancreatic islet cells can be prevented by nicotinamide. Life Sci 51: 671–678
Buscema M, Vinci C, Gatta C, Rabuazzo AM, Vigneri R, Purrello F (1992) Nicotinamide partially reverses the inter-leukin-lbeta inhibition of glucose induced insulin release in pancreatic islets. Metabolism 41: 296–300
Varsnyi-Nagy M, Dadufalza V, Buckingham B et al. (1992) Protective effect of nicotinamide on preservation of mouse islet function and morphology. Diabetologia 35 [Suppl]: A129 (Abstract)
Vague PH, Vialettes B, Lassman-Vague V, Vallo JJ (1987) Nicotinamide may extend remission phase in insulin dependent diabetes. Lancet I:619–620 (Letter)
Pozzilli P, Visalli N, Ghirlanda G, Manna R, Andreani D (1989) Nicotinamide increases C-peptide secretion in patients with recent onset type 1 diabetes. Diabet Med 6: 568–572
Vague P, Picq R, Bernal M, Lassman-Vague V, Vialettes B (1989) Effect of nicotinamide treatment in the residual insulin secretion in type 1 (insulin-dependent) diabetic patients. Diabetologia 32: 316–321
Mendola G, Casamitjana R, Gomics R (1989) Effect of nicotinamide therapy upon B-cell function in newly diagnosed type 1 (insulin-dependent) diabetic patients. Diabetologia 32: 160–162
Chase HP, Butler-Simon N, Garg S, McDuffe M, Hoops SL, O'Brien D (1990) Trial of nicotinamide in newly diagnosed patients with type 1 (insulin-dependent) diabetes mellitus. Diabetologia 33: 444–446
Lewis CM, Canafax DM, Sprafka JM, Barbosa JJ (1992) Double blind randomized trial of nicotinamide on early onset diabetes. Diabetes Care 15: 121–123
Vialettes B, Picq R, Du Rostu M et al. (1991) A preliminary multicentre study of the treatment of recently diagnosed type 1 diabetes by combination nicotinamide-cyclosporin therapy. Diabet Med 7: 731–735
Pozzilli P, Visalli N, Boccuni ML, et al. (1994) Randomizedtrial comparing nicotinamide plus cyclosporin in recent onset insulin dependent diabetes. Diabet Med 11: 98–104
Buzzetti R, Nisticò L, Osborn JF et al. (1993) HLA-DQA1 and DQB1 gene polymorphisms in type 1 (insulin dependent) diabetic patients from central Italy and their use for risk prediction. Diabetes 42: 1173–1178
Rossetti L, Giaccari A, DeFronzo RA (1990) Glucose toxicity. Diabetes Care 13: 610–630
Leahy JL, Bonner-Weir S, Weir GC (1992) Beta cell dysfunction induced by chronic hyperglycemia. Current ideas on mechanism of impaired glucose-induced secretion. Diabetes Care 15: 442–455
Muir A, Schatz DA, Pozzilli P, Maclaren NK (1993) Intervention therapies for insulin-dependent diabetes. Autoimmunity 16: 301–310
Pozzilli P, Andreani D (1990) Type 1 diabetes at presentation of juvenile diabetes. BMJ ii: 211–212
Pinkney JH, Bingley PJ, Sawtell PA, Dunger DB, Gale EAM, The Bart’s-Oxford Study Group (1994) Presentation and progress of childhood diabetes mellitus: a prospective population-based study. Diabetologia 37: 70–74
Sjöberg S, Gunnarsson R, Gjotterberg M, Lefvert AK, Persson A, Östman J (1987) Residual insulin-production glycaemic control and prevalence of microvascular lesions and polyneuropathy in long-term type 1 (insulin-dependent) diabetes mellitus. Diabetologia 30: 208–211
Chase P, Dupre J, Mahon J et al. (1992) Nicotinamide and prevention of diabetes. Lancet 339: 1051–1052
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
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
Received:
Revised:
Issue Date:
DOI: https://doi.org/10.1007/s001250050362