A DOUBLE-BLIND-STUDY ON THE EFFICACY AND TOLERANCE OF A NEW ALPHA-GLUCOSIDASE INHIBITOR IN TYPE-2 DIABETICS

Abstract

Miglitol (Bay m 1099), a deoxynojirimycin derivative, is a new glucosidase inhibitor. The possible hypoglycemic effect of this new product was tested in 12 volunteer noninsulin-dependent diabetes (NIDDs) in a double-blind crossover acute study. The patients twice received a test meal (1554 kJ including 34 g carbohydrates), once with placebo and on another day with a 50-mg tablet of Bay m 1099. A wash-out period of 2 to 7 days separated the test days. Venous blood samples were collected before and every 30 min for a total of 3 h after the drug administration. Mean blood sugar values were in general lower after the meal + Bay m 1099 than the meal + placebo. The differences were statistically significant at the 60- and 90-min time intervals (8.43 versus 11.17 and 9.24 versus 11.59 mmol/l, respectively, p < 0.05). No flatulence, diarrhea or other untoward effects were observed. Furthermore no changes in serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, creatinine, alkaline phosphatase, bilirubin, haemoglobin, white blood count and differential counts were noted. Thus, in a one-day study 50 mg of Bay m 1099 reduced the postprandial hyperglycemia in NIDDs. No signs of any acute renal, liver and blood toxicity were observed.