Objective: This 36-week multicenter double-blind placebo-controlled study was designed to assess the safety and efficacy of acarbose, administered in conjunction with diet and insulin therapy, for the treatment of patients with type I diabetes.
Research design and methods: Acarbose was administered using a forced titration protocol in dosages ranging from 50 to 300 mg t.i.d.
Results: Treatment with acarbose was associated with a mean reduction in postprandial glucose levels (60 min after the administration of a test meal) of 59 mg/dl and a mean reduction in HbA1c levels of 0.48%. There was no difference in the incidence 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 patients.
Conclusions: Acarbose was found to be a safe and effective agent, when used in combination with diet and insulin therapy, for the treatment of type I diabetes.