OBJECTIVE - This 36-week multicenter double-blind placebo-controlled s
tudy was designed to assess the safety and efficacy of acarbose, admin
istered in conjunction with diet and insulin therapy, for the treatmen
t of patients with type I diabetes. RESEARCH DESIGN AND METHODS - Acar
bose was administered using a forced titration protocol in dosages ran
ging from 50 to 300 mg t.i.d. RESULTS - Treatment with acarbose was as
sociated with a mean reduction in postprandial glucose levels (60 min
after the administration of a test meal) of 59 mg/dl and a mean reduct
ion in HbA(1c) levels of 0.48%. There was no difference in the inciden
ce of hypoglycemia between treatment groups. Gastrointestinal events,
including flatulence, diarrhea, and abdominal pain, were reported more
frequently in acarbose-treated patients than in placebo-treated patie
nts. CONCLUSIONS - Acarbose was found to be a safe and effective agent
, when used in combination with diet and insulin therapy, for the trea
tment of type I diabetes.