CLINICAL EFFICACY AND TOLERANCE OF ACARBOSE IN THE TREATMENT OF INSULIN-DEPENDENT DIABETIC-PATIENTS (TYPE-I)

BACKGROUND: Acarbose is a reversible inhibitor of the intestinal alpha glucosidases, the oral administration of which delays or diminishes th e postprandial increase of glucose and insulin. METHODS: A multicentri c double-blind clinical trial (11 centers), controlled versus placebo, crossed and randomized, was carried out with 137 insulin-dependent di abetic type I patients treated with diet and insulin. During the first 3 months of the trial the patients received placebo or acarbose rando mly. Following one month of wash out with placebo the patients receive d the inverse medication for 3 more months. During the first month of each phase the patients were given 50 mg three times per day of acarbo se or placebo and the two following moths received 100 mg x 3/day. RES ULTS: Upon comparison of the two treatments significant statistical di fferences were found in HbA1 (p = 0.0005) and in postprandial glycemia (p = 0.007). There were differences, although not statistically signi ficant, in the amounts of triglycerides, cholesterol and fasting glyce mia. One hundred and two patients referred adverse events, most being gastrointestinal (flatulence, meteorism). CONCLUSIONS: Acarbose may be useful in the treatment of insulin-dependent diabetic type I patients treated with insulin and diet since it reduces the levels significant ly of HbA1 and postprandial glucose.