Assessment of the clinical efficacy and tolerance of two new alpha-glucosidase inhibitors in insulin-treated diabetics.

The present study aimed at investigating the metabolic effects and tolerance of two desoxynojirimycin derivatives with alpha-glucosidase inhibitory properties (BAY m 1099 and BAY o 1248). The study was performed in a double-blind cross-over manner on 7 insulin-treated outpatient diabetics (6 males, 1 female; mean age 43 +/- 14 years; mean duration of diabetes 5.8 +/- 4.2 years; all within +/- 10% of their ideal body weight). The usual diet containing 24.5 +/- 8 g dietary fibers and 52 +/- 22 g simple sugars was maintained throughout the study. After a 7-day run-in period, 4 consecutive periods of 7 days were considered for each patient. The patients were randomly allocated for 1 week to BAY o 1248 (20 mg with breakfast) or Bay m 1099 (50 mg with breakfast and dinner). After a 7-day wash-out period the patients underwent the alternate treatment. At the end of each period, the patients were admitted to the Metabolic Ward for detailed metabolic and hormonal investigations. No significant changes were observed in the daily insulin requirements (45 +/- 15 U/day). HbA1c did not change significantly. Residual insulin secretion was low (plasma C-peptide: 0.077 +/- 0.09 and 0.154 +/- 0.15 pmol/ml during fasting and 2 hours post-breakfast, respectively); it was not modified by the treatments. Increments in blood glucose were significantly lower after breakfast with both drugs. No differences were observed in plasma free insulin. A marked increase in breath hydrogen was observed after lunch with BAY o 1248 only. Clinical and biological tolerance was excellent for both compounds.(ABSTRACT TRUNCATED AT 250 WORDS)