Combination of nicotinamide and steroid versus nicotinamide in recent-onset IDDM. The IMDIAB II Study.
OBJECTIVE
The aim of this study was to compare the effect of nicotinamide (NCT) alone or in combination with a cortisone-like substance, deflazacort (DFL), on the integrated parameters of metabolic control in patients with the recent-onset of insulin-dependent diabetes mellitus (IDDM).


METHODS
Thirty-six patients who were diagnosed with diabetes between 5 and 35 years of age entered a randomized, double-blind, 1-year prospective study. Group A (n = 18) received NCT for 1 year (25 mg.kg-1.day-1) plus DFL for 3 months (0.6 mg.kg-1.day-1 in the first month, 0.3 mg.kg-1.day-1 in the other 2 months). Group B (n = 18) received NCT for 1 year (25 mg.kg-1.day-1) plus placebo for the first 3 months. All patients were treated with intensified insulin therapy.


RESULTS
At 3 months after diagnosis, the insulin dose was significantly higher in group A compared with group B (P < 0.03) with similar HbA1 levels. Basal and stimulated C-peptide levels in group A of both adults and children were significantly higher compared with patients of group B (P < 0.05 and P < 0.03, respectively). At the end of a 1-year follow-up, basal C-peptide did not differ between the two groups, although stimulated C-peptide was still significantly higher in patients of group A compared with group B (P < 0.05). Finally, insulin requirement did not differ between the two groups.


CONCLUSIONS
A short-term course of DFL therapy at diagnosis in addition to NCT slightly increases glucagon-stimulated but not basal beta-cell function after 1 year.
Pozzilli
P
P
Istituto di Clinica Medica II, Universita di Roma La Sapienza, Italy.
Visalli
N
N
Boccuni
M L
ML
Baroni
M G
MG
Buzzetti
R
R
Fioriti
E
E
Signore
A
A
Cavallo
M G
MG
Andreani
D
D
Lucentini
L
L
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002096:C-Peptide / Q000097:blood; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005934:Glucagon; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D009536:Niacinamide / Q000627:therapeutic use*; D011282:Pregnenediones / Q000627:therapeutic use*
D000893:Anti-Inflammatory Agents; D002096:C-Peptide; D005934:Glucagon; D006442:Glycated Hemoglobin; D007328:Insulin; D009536:Niacinamide; D011282:Pregnenediones; C021988:deflazacort