Abstract
Objective: The objective of this study was to evaluate and compare the effects of gliclazide-modified
release (gliclazide-MR), metformine (MET) and pioglitazone (PIO) monotherapies on
glycemic control and conventional/non-conventional cardiovascular risk factors in
patients with newly diagnosed type 2 diabetes mellitus (T2DM).
Material and Methods: A single center, randomized, 52-wk comparator-controlled clinical study was carried
out in patients with newly diagnosed uncontrolled T2DM. A total of 57 patients were
randomized into gliclazide-MR, metformin and pioglitazone groups. Drugs were administered
for 12 months. Anthropometric measurements, fasting plasma glucose (FPG), postprandial
plasma glucose (PPG), HbA1c, insulin, HOMA-IR, lipid parameters, the markers of coagulation/fibrinolysis,
inflammation and endothelial dysfunction were measured at baseline and at months 3,
6, and 12.
Results: In the gliclazide-MR group, HC, FPG, HbA1c, insulin, HOMA-IR, TC, trigylcerides,
Lp (a), E-selectin and Hcy were significantly decreased after treatment compared to
baseline. In the MET group, BMI, WC, FPG, PPG, HbA1c, ICAM-1 and Hcy significantly
decreased after treatment compared to baseline. In PIO group, WC, HC, FPG, PPG, HbA1c,
C-peptid, HOMA-IR, trigylcerides, vWF, IL-6, ICAM-1, E-selectin and Hcy significantly
decreased after treatment compared to baseline, whereas, HDL-C increased. At the end
of the month 12, the decreases in insulin and HOMA-IR score were more pronounced with
PIO compared to gliclazide.
Conclusions: Gliclazide-MR, MET and PIO monotherapies, were equally effective in proving glycemic
control in patients with newly diagnosed, oral antidiabetic (OAD)-naive T2DM. But,
improvements in conventional/non-conventional cardiovascular risk factors were more
pronounced in patients on PIO therapy compared to gliclazide and MET therapies. Also,
all of the 3 drugs represent effective and safe first-line pharmacological treatment
options in these patients.
Key words gliclazide-MR - metformin - pioglitazone - type 2 diabetes - cardiovascular risk factors
- glycemic control