Aim: To compare the effect of acarbose and gliclazide on clinical findings,
biochemical parameters and safety in type 2 diabetic patients insufficient
ly controlled with medical nutrition therapy (MNT).
Methods: Seventy-two patients (age 35-70 years, BMI I 35 kg/m(2)), who had
not taken any oral antidiabetic drug previously, were randomised into two g
roups after a four-week placebo period, and treated for 24 weeks with acarb
ose (100 mg two to three times daily and gliclazide (40-80 mg twice daily).
The study was open and 57 patients (33 males and 24 females) completed it.
MNT was provided for each patient based on personal requirements as define
d by a dietitian. The effect of treatment was evaluated by fasting and post
prandial (PP) metabolic parameters (blood glucose, insulin and C peptide le
vels), HbA(1C) and plasma lipid levels. lit addition, side-effects were rec
orded and clinical examinations performed.
Results: Both drugs were effective in reducing of HbA(1C) fasting and PP bl
ood glucose levels. However, PP serum insulin levels in the gliclazide grou
p increased more than those in the group treated with acarbose (p = 0.007).
Moreover; a small weight reduction was obtained with acarbose treatment bu
t not with gliclazide. Lipid levels were favourably affected by bath drugs.
Total cholesterol levels decreased in both groups, the decrease only reach
ing significance in the acarbose group (p = 0.013). However, serum levels o
f LDL cholesterol decreased in both groups (acarbose and gliclazide, p = 0.
033 and p = 0.023, respectively), but the ratio of HDL to LDL cholesterol i
ncreased in the acarbose group only (p = 0.045). Both treatments were gener
ally well tolerated. Common complaints in the acarbose group were flatulenc
e and meteorism (29.6%). However, 10.0% of the patients in the gliclazide g
roup reported at least one mild hypoglycaemic episode.
Conclusions: The results of the study demonstrate that acarbose and gliclaz
ide were reasonably effective in improving metabolic control in patients in
sufficiently controlled with diet alone, and both treatments were well tole
rated. Because of its effects apr weight reduction and PP hyperinsulinaemia
acarbose may be preferred as a first-line drug, particularly in the treatm
ent of overweight type 2 diabetic patients.