Erem C, Ozbas H M, Nuhoglu I, Deger O, Civan N, Ersoz H O
Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
Department of Medical Biochemistry, The Trabzon Endocrinological Studies Group, Trabzon, Turkey.
Exp Clin Endocrinol Diabetes. 2014 May;122(5):295-302. doi: 10.1055/s-0034-1370989. Epub 2014 Apr 7.
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).
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.
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.
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.
本研究旨在评估和比较格列齐特缓释片（gliclazide-MR）、二甲双胍（MET）和吡格列酮（PIO）单药治疗对新诊断的2型糖尿病（T2DM）患者血糖控制及传统/非传统心血管危险因素的影响。
对新诊断的未控制T2DM患者进行了一项单中心、随机、为期52周的对照临床研究。共57例患者随机分为格列齐特缓释片组、二甲双胍组和吡格列酮组。药物治疗12个月。在基线以及第3、6和12个月时测量人体测量指标、空腹血糖（FPG）、餐后血糖（PPG）、糖化血红蛋白（HbA1c）、胰岛素、胰岛素抵抗指数（HOMA-IR）、血脂参数、凝血/纤溶标志物、炎症标志物及内皮功能障碍标志物。
与基线相比，格列齐特缓释片组治疗后臀围（HC）、FPG、HbA1c、胰岛素、HOMA-IR、总胆固醇（TC）、甘油三酯、脂蛋白（a）[Lp（a）]、E-选择素和同型半胱氨酸（Hcy）显著降低。二甲双胍组治疗后体重指数（BMI）、腰围（WC）、FPG、PPG、HbA1c、细胞间黏附分子-1（ICAM-1）和Hcy较基线显著降低。吡格列酮组治疗后WC、HC、FPG、PPG、HbA1c、C肽、HOMA-IR、甘油三酯、血管性血友病因子（vWF）、白细胞介素-6（IL-6）、ICAM-1、E-选择素和Hcy较基线显著降低，而高密度脂蛋白胆固醇（HDL-C）升高。在第12个月末，与格列齐特相比，吡格列酮使胰岛素和HOMA-IR评分的降低更明显。
格列齐特缓释片、二甲双胍和吡格列酮单药治疗对新诊断的、未使用过口服降糖药（OAD）的T2DM患者血糖控制效果相当。但是，与格列齐特和二甲双胍治疗相比，吡格列酮治疗的患者传统/非传统心血管危险因素改善更明显。此外，这三种药物都是这些患者有效且安全的一线药物治疗选择。
