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

Background Patients 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 res ults of a recent meta analysis of the use of NA in patients with recent-ons et 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 wer e 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/k g (b.w.) of NA. Intensive insulin therapy was carried out in order to optim ize metabolic control as soon as possible after diagnosis and to maintain b lood glucose level as near to normal as possible. Response to therapy was m onitored throughout the study by investigating the occurrence of clinical ( complete) remission defined, according to the recommendations of the Intern ational Diabetes Immunotherapy Group, as restoration of normal fasting and post-prandial blood glucose without any (NA) can be beneficial. This concep t is reinforced by the results of a recent meta-analysis of the use of NA i n patients with recent-onset Type 1 diabetes. Methods In this study we comp ared two different doses of NA in 74 patients with duration of Type 1 diabe tes <4 weeks (mean age 13 years). insulin administration for more than 2 we eks. Moreover, the integrated measures of metabolic control (C-peptide, HbA (1c), and insulin dose) were analysed at 3- month intervals up to 1 year af ter 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 trea ted with two different doses of NA, in addition to intensive insulin therap y, 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 sma ller dose of 25 mg/kg NA would be sufficient as a higher dose may induce in sulin resistance. Copyright (C) 1999 John Wiley & Sons, Ltd.