A double blind, randomised, placebo controlled study to assess the maximuminsulin dose reduction achieved with acarbose in the treatment of insulin-requiring Type 2 diabetic patients

Results from some studies suggest that acarbose could reduce insulin dosage in Type 2 insulin-requiring diabetic patients but few data are available. A multicentre, double blind, randomised, placebo controlled study was perfo rmed to evaluate the maximum insulin dose reduction achieved when 100 mg x 3 of acarbose is added to the treatment of Type 2 insulin-treated diabetic patients and to evaluate its tolerability, The study population consisted o f 70 patients (33 in the acarbose group and 37 in the placebo group) with a primary diagnosis of Type 2 diabetes of at least two years duration, in tr eatment with diet plus insulin and with a positive C-peptide, Patients were randomised into two groups, acarbose 100 mg x 3 times daily or placebo x 3 times daily, They followed the same diet throughout the study and were exa mined every 6 weeks for 6 months. The insulin dosage was adjusted according to the value of HbA(1c). The interaction between treatment and initial dos e of insulin had a significant effect on the final insulin dose and it was found that a reduction to the 85% of initial insulin dose is expected after 12 weeks treatment with acarbose, but no reduction is expected with placeb o. A reduction to 81% was found in the analysis performed with the last ins ulin dose observed. The analysis of HbA(1c), glucose, cholesterol and trigl ycerides did not show any differences between the two treatment groups. Mos t common adverse events were flatulence and meteorism, Acarbose, in combina tion with diet and insulin therapy, can be a useful tool to treat these pat ients as it reduces insulin needs by about 15%-20%.