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A Preliminary Multicentre Study of the Treatment of Recently Diagnosed Type 1 Diabetes by Combination Nicotinamide‐Cyclosporin Therapy
Author(s) -
Vialettes B.,
Picq R.,
Rostu M.,
Charbonnel B.,
Rodier M.,
Mirouze J.,
Vexiau P.,
Passa Ph.,
Pehuet M.,
Elgrably F.,
Vague Ph.
Publication year - 1990
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.1990.tb01478.x
Subject(s) - medicine , placebo , postprandial , diabetes mellitus , gastroenterology , type 2 diabetes , type 1 diabetes , insulin , nicotinamide , surgery , endocrinology , biochemistry , chemistry , enzyme , alternative medicine , pathology
The aim of the present study, a pilot trial, was to find out if nicotinamide (50 mg kg −1 day −1 ) in combination with cyclosporin A favours remission in recently diagnosed Type 1 diabetic patients, and if it postpones relapse even when cyclosporin A is administered in decreasing doses (trough blood level 300–500 (μg l −1 until month 4, and 100–300 μg l −1 until month 9) and then discontinued. The criteria for inclusion in the study and the follow‐up protocol were the same as those used in the Cyclosporin Diabetes France (CDF) programme in which all five of the centres involved in this study participated. The data of the present preliminary open study were therefore compared retrospectively with those of the placebo (CDF‐placebo) and cyclosporin (CDF‐active) group of the CDF programme. Clinical remission (fasting plasma glucose <7.8 mmol l −1 , postprandial plasma glucose < 11.1 mmol l −1 , HbA 1c < 7.5 % with neither insulin nor oral hypoglycaemic agents) was achieved within 6 months in 12 out of 35 patients (34 %) vs 16 out of 63 (25 %) in CDF‐active and 11 out of 59 (19 %) in CDF‐placebo. Remission was achieved by month 9 in 6 out of 35 patients (17 %) vs 13 out of 54 (24 %) in CDF‐active and 3 out of 52 (6 %) in CDF‐placebo. By 12 months remission persisted in 3 out of 35 patients (9 %) vs 11 out of 63 (17 %) in CDF‐active and 0 out of 52 (0 %) in CDF‐placebo. Only CDF‐active at months 9 and 12 was significantly different from CDF‐placebo ( p < 0.05). The daily insulin doses of the nicotinamide‐cyclosporin group were not different from those administered to CDF‐placebo patients at month 12. Post‐stimulation C‐peptide values were comparable to those measured in CDF‐active up to month 9 but dropped to a level comparable to those measured in CDF‐placebo when cyclosporin A was discontinued. Combining nicotinamide with cyclosporin A does not significantly improve the remission rate and does not prolong remission after discontinuation of cyclosporin A.