This double-blind study was performed to evaluate the relation of the glycemic and hormonal (
insulin,
gastric inhibitory polypeptide) responses to standardized
starch and
sucrose meals to signs (H2 exhalation) and subjective symptoms of
carbohydrate malabsorption during administration of 100 mg BAYm 1099 (
miglitol) t.i.d. over a period of 8 weeks. Two groups of 8 male healthy volunteers received either placebo or verum. Oral
sucrose loading tests (50 g) with and without
miglitol were performed at day -5, 1, 25 and 53 of the study,
starch loading tests (50 g) with and without the inhibitor were carried out at day -2, 4, 28 and 56.
Miglitol significantly flattened the glycemic responses to
sucrose and
starch without evidence of diminished efficacy over the 8-week period. Also the blunting effect of
miglitol on serum
insulin and
gastric inhibitory polypeptide responses and the stimulation of breath
hydrogen exhalation proving
carbohydrate malabsorption with
starch and
sucrose remained unchanged over time. Comparing breath
hydrogen exhalation, responses were more pronounced after
sucrose than after the
starch loading tests. Symptoms (bloating,
flatulence,
diarrhea,
cramps) were merely noticeable with
starch as the substrate, but clearly present after
sucrose. These symptoms were substantially curtailed during continuous
drug intake. It is concluded that - irrespective of the substrate (
starch/
sucrose) - there is no escape of the desired effects of
alpha-glucosidase inhibition by
miglitol over 8 weeks, but symptoms of gaseousness due to
carbohydrate malabsorption may undergo habituation.