Aims It has been speculated that acarbose treatment in patients with Type 2
diabetes mellitus might induce changes in diet as a result of its adverse
gastrointestinal effects. The aim of this study was to determine whether po
or metabolic control can be improved by acarbose, and whether this might be
because the acarbose supplementation provokes changes in diet.
Methods Poorly controlled Type 2 diabetic patients treated with oral hypogl
ycaemic agents (OHA) were randomized into either acarbose (100 mg t.d.s.) o
r placebo treatment. The double-blind treatment lasted for 24 weeks. Four-d
ay food diaries and blood samples for efficacy analysis were collected at 0
, 4, 12, and 24 weeks. Thirty-six acarbose and 39 placebo-treated patients
completed the trial and were included in the final analyses.
Results At 24 weeks the baseline adjusted means of fasting, 1 and 2-h postp
randial blood glucose values were 9.3 vs. 10.5 (P = 0.02), 11.6 vs. 14.5 (P
< 0.001) and 11.0 vs. 13.7 mmol/l (P < 0.001) and HbA(1) 9.3% vs. 10.2% (P
= 0.002) in the acarbose and placebo groups, respectively. No significant
differences in nutrient intakes between groups were observed, The energy in
take and energy proportion of fat and carbohydrates remained unchanged in b
oth groups.
Conclusions Acarbose significantly improves metabolic control in Type 2 dia
betic patients poorly controlled with oral hypoglycaemic agents. This effec
t seems not to be a result of concomitant involuntary dietary changes, sinc
e acarbose did not induce modifications in diet during the study.