Comparison of effects of gliclazide, metformin and pioglitazone monotherapies on glycemic control and cardiovascular risk factors in patients with newly diagnosed uncontrolled type 2 diabetes mellitus.
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).


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.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
C
C
Erem
Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
H M
HM
Ozbas
Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
I
I
Nuhoglu
Department of Medical Biochemistry, The Trabzon Endocrinological Studies Group, Trabzon, Turkey.
O
O
Deger
Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
N
N
Civan
Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
H O
HO
Ersoz
D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy; D005260:Female; D005907:Gliclazide / Q000008:administration & dosage*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D008687:Metformin / Q000008:administration & dosage*; D008875:Middle Aged; D000077205:Pioglitazone; D012307:Risk Factors; D045162:Thiazolidinediones / Q000008:administration & dosage*
D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D008687:Metformin; D005907:Gliclazide; D000077205:Pioglitazone