Effects of BAYm 1099, new alpha-glucosidase inhibitor, on acute metabolic responses and metabolic control in NIDDM over 1 mo.
To examine the clinical role of BAYm 1099, 15 diet-treated non-insulin-dependent diabetic (NIDDM) subjects were randomized to start drug (50 mg 3 times/day) or placebo after a 4-wk run-in period in a double-blind crossover study. Treatment periods (4 wk) were separated by a 2-wk washout period. During the last week of each treatment period, three test meals (TMs) were administered: 60 g starch (TM1), 25 g sucrose (TM2), and combined 60 g starch and 25 g sucrose (TM3). Twelve subjects completed the study. The peak postprandial blood glucose, lactate, and pyruvate levels (means +/- SE) were significantly lower with active drug after all test meals, particularly TM2 (11.3 +/- 1.0 vs. 14.3 +/- 1.4 mM, P less than .001; 1.53 +/- 0.20 vs. 2.48 +/- 0.17 mM, P less than .001; and 105.1 +/- 17.6 vs. 147.6 +/- 11.1 microM, P less than) less than .001; and 105.1 +/- 17.6 vs. 147.6 +/- 11.1 microM, P less than .05, respectively. Peak blood glucose levels were significantly delayed. However, fasting blood glucose, HbA1, fructosamine, and cholesterol did not change during active treatment (10.0 +/- 1.0 vs. 9.9 +/- 1.0 mM, 10.0 +/- 0.7 vs. 9.4 +/- 0.7%, 2.44 +/- 0.10 vs. 2.37 +/- 0.07 mmol/100 g protein, and 6.7 +/- 0.3 vs. 6.5 +/- 0.3 mM, P NS). Flatulence and diarrhea were severe in 2 subjects, requiring termination of study. Thus, in NIDDM, BAYm 1099 was effective in diminishing and delaying postprandial excursions of blood glucose, lactate, and pyruvate after high- and low-sucrose meals, but overall metabolic control remained unchanged.(ABSTRACT TRUNCATED AT 250 WORDS)
D017485:1-Deoxynojirimycin / Q000031:analogs & derivatives; D020155:3-Hydroxybutyric Acid; D000409:Alanine / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002986:Clinical Trials as Topic; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004435:Eating; D005230:Fatty Acids, Nonesterified / Q000097:blood; D005260:Female; D005944:Glucosamine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005990:Glycerol / Q000097:blood; D065089:Glycoside Hydrolase Inhibitors; D006801:Humans; D006885:Hydroxybutyrates / Q000097:blood; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D050112:Imino Pyranoses; D007328:Insulin / Q000097:blood; D007773:Lactates / Q000097:blood; D008297:Male; D008875:Middle Aged; D011773:Pyruvates / Q000097:blood
D001786:Blood Glucose; D005230:Fatty Acids, Nonesterified; D065089:Glycoside Hydrolase Inhibitors; D006885:Hydroxybutyrates; D007004:Hypoglycemic Agents; D050112:Imino Pyranoses; D007328:Insulin; D007773:Lactates; D011773:Pyruvates; C045621:miglitol; D017485:1-Deoxynojirimycin; D005944:Glucosamine; D000409:Alanine; D005990:Glycerol; D020155:3-Hydroxybutyric Acid