Department of Geriatric EndocrinologyChinese PLA General Hospital, 28 Fu Xing Road, Beijing 100853, People's Republic of ChinaDepartment of EndocrinologyBeijing Haidian Hospital, 29 Huangzhuang, Zhongguangcun Street, Beijing 100080, People's Republic of China.
Department of Geriatric EndocrinologyChinese PLA General Hospital, 28 Fu Xing Road, Beijing 100853, People's Republic of ChinaDepartment of EndocrinologyBeijing Haidian Hospital, 29 Huangzhuang, Zhongguangcun Street, Beijing 100080, People's Republic of China
Eur J Endocrinol. 2014 Jun;170(6):901-8. doi: 10.1530/EJE-14-0052. Epub 2014 Apr 2.
We aimed to compare the effect of repaglinide and metformin monotherapy as an initial therapy in Chinese patients with newly diagnosed type 2 diabetes mellitus (T2DM).
In this 15-week, open-labelled, parallel-controlled, randomised study, 60 Chinese drug-naive patients with newly diagnosed T2DM were randomised (2:1) to receive repaglinide or metformin monotherapy. Primary endpoint was change in HbA1c from baseline to the end of the trial. Secondary endpoints included changes in glycaemic variability, insulin sensitivity and β-cell function.
Patients in both repaglinide and metformin groups achieved significant reductions in HbA1c (-1.8 ± 1.5 vs -1.6 ± 1.5%), FPG (fasting blood glucose) (-1.7 ± 1.7 vs -2.1 ± 1.7 mmol/l) and 2-h PPG (post-prandial glucose) (-3.8 ± 3.1 vs -3.8 ± 3.6 mmol/l), with no statistical differences between the groups. Glycaemic variability, glucose infusion rate and β-cell function were all significantly improved from baseline in the two groups (all P<0.05), without any statistical differences in the improvement between the groups.
Repaglinide and metformin achieved comparable efficacy in improving glycaemic control, reducing glycaemic variability, enhancing insulin sensitivity and ameliorating β-cell function. Therefore, repaglinide is an optional agent for initial therapy in Chinese patients with newly diagnosed T2DM.
本研究旨在比较瑞格列奈和二甲双胍单药治疗作为中国新诊断 2 型糖尿病（T2DM）患者初始治疗的效果。
这是一项为期 15 周、开放标签、平行对照、随机研究，纳入 60 例中国新诊断 T2DM 且未接受药物治疗的患者，按照 2:1 的比例随机分为瑞格列奈组或二甲双胍组。主要终点是从基线到试验结束时 HbA1c 的变化。次要终点包括血糖变异性、胰岛素敏感性和β细胞功能的变化。
瑞格列奈组和二甲双胍组患者的 HbA1c（-1.8 ± 1.5% vs. -1.6 ± 1.5%）、FPG（-1.7 ± 1.7% vs. -2.1 ± 1.7 mmol/l）和 2-hPPG（-3.8 ± 3.1% vs. -3.8 ± 3.6 mmol/l）均显著降低，两组间无统计学差异。两组患者的血糖变异性、葡萄糖输注率和β细胞功能均较基线显著改善（均 P<0.05），两组间改善程度无统计学差异。
瑞格列奈和二甲双胍在改善血糖控制、降低血糖变异性、提高胰岛素敏感性和改善β细胞功能方面具有相当的疗效。因此，瑞格列奈是中国新诊断 T2DM 患者初始治疗的可选药物。
