EFFECTS OF ACARBOSE (GLUCOBAY(R)) IN PERSONS WITH TYPE-1 DIABETES - AMULTICENTER STUDY

The aim of this multicentre study was to investigate the effect-in eve ryday life-of long term administration of acarbose on parameters of gl ycaemic control, daily insulin requirements, lipid parameters and tole rability in ambulant type 1 diabetic subjects insufficiently controlle d with diet and insulin. Furthermore, effects on lipid parameters were to be studied. A total of 16 patients withdrew from the study, 13 of these during the acarbose medication period. For four of these 13 pati ents the adverse event started during the placebo run-in period. The d ata of 62 patients (35 men and 27 women, mean age 38 (range 18-64) yea rs, median duration of diabetes 10 (range 1-40) years) were valid for statistical analysis. The median daily dose of acarbose at the final a ssessment (i.e. after 16 weeks of active treatment) was 200 (range 75- 300) mg. During the placebo run-in period HbA(1c) levels tended to dec rease from 8.9 +/- 1.1 to 8.5 +/- 0.9%. After 8 and 16 weeks of acarbo se treatment the mean level had decreased further to 8.1 +/- 0.9 and 8 .2 +/- 0.9%, respectively (both P < 0.001). After stopping acarbose Hb A(1c) levels increased again to a mean level of 8.6 +/- 0.9%. Mean lev els of HbA(1c) per centre followed the same profile. Seven-point blood glucose profiles followed the same pattern. None of these changes ove r time reached statistical significance except for a significant drop during acarbose treatment of the time-point 90 min after lunch (P < 0. 01). After stopping acarbose treatment values returned to pre-study le vels. For total cholesterol, HDL-cholesterol, triglycerides, Apo Al an d Apo B, and Lp(a) no significant changes were observed. Daily insulin dose was 48 (range 26-92) U at the start of the study and did not cha nge. The most frequent reported adverse events were flatulence (43%), diarrhoea (27%), and abdominal pain (11%). We conclude that acarbose u p to 3 x 100 mg/day can be a valuable adjunct to insulin in improving metabolic control in persons with type 1 diabetes. (C) 1998 Elsevier S cience Ireland Ltd. All rights reserved.