A 1-year open randomized controlled multicentre trial was carried out on 90 patients with recent onset (-1 day-1 (n = 30) or NCT 25 mg kg-1 day-1 + CyA 5 mg kg-1 day-1 (n = 30), the latter adjusted to maintain 12 whole blood trough levels of 83 nmol l-1; a third group of patients (n = 30) receiving insulin only acted as a control group for spontaneous remission and metabolic control. Clinical remission (i.e. suspension of insulin therapy with normal metabolic paraters for more than 2 weeks according to the International Diabetes Immunotherapy Group) was achieved at 3 months in 6/30 NCT treated patients and in 1/30 NCT + CyA treated patient (p = 0-.05); no remission was observed in control patients. At 6 months the number of patients achieving remission in each group was 4/29, 3/27, and 1/29, respectively (p = NS). One year after diagnosis 4/27 NCT treated, 2/25 NCT + CyA treated but 0/28 of the control patients were in remission (NCT vs control p = 0.05). Clinical remission lasted longer (7 ± 3 SD months) in NCT treated patients than in NCT + CyA treated or control patients (p <0.02). In patients who did not show clinical remission, there were no significant differences in the integrated measures of metabolic control (HbA1 and C peptide) between the two groups; however, NCT + CyA treated patients only required significantly less insulin at 12 months compared to control patients (p <0.02). Side-effects were not observed in patients receiving NCT and were minimal in those treated with the combination of NCT + CyA. We conclude that nicotinamide alone is a safe and effect adjunct to insulin in the early phase of IDDM to increase the rate of clinical remission and to improve integrated parameters of metabolic control.
|Number of pages||7|
|Publication status||Published - 1994|
- Insulin-dependent diabetes
ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism
- Internal Medicine