Division of Diabetes and Metabolism, The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan.
Diabetes Res Clin Pract. 2010 Sep;89(3):216-23. doi: 10.1016/j.diabres.2010.04.017.
To investigate the efficacy and tolerability of vildagliptin, a potent and selective dipeptidyl peptidase-4 inhibitor, as add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus (T2DM) who were inadequately controlled.
This 12-week, randomized, double-blind, placebo-controlled study compared vildagliptin 50mg twice-daily (n=102) with placebo (n=100) when added to a stable dose of glimepiride (>or=1mg/d).
Treatment groups were balanced at baseline (glycosylated hemoglobin [HbA(1c)], 7.9%; fasting plasma glucose, 163.8 mg/dL). During treatment HbA(1c) decreased progressively with vildagliptin, but remained unchanged with placebo. The adjusted mean change (AMDelta) at endpoint was -1.0+/-0.1 and -0.1+/-0.1% in vildagliptin- and placebo-treated patients (between-group Delta=-1.0+/-0.1%, P<0.001). A greater proportion of vildagliptin-treated patients had HbA(1c) <or=6.5% compared to placebo-treated patients (45% vs. 3%, P<0.001). The AMDelta FPG was -20.9+/-2.8 mg/dL with vildagliptin compared to 6.3+/-2.8 mg/dL with placebo (between-group Delta=-27.2+/-3.9 mg/dL, P<0.001). Patients in vildagliptin and placebo groups reported similar incidences of adverse events (AEs) (59.8% vs. 57.0%), serious AEs (0% vs. 2.0%), suspected drug-related AEs (21.6% vs. 23.0%), and discontinuation due to AEs (1.0% vs. 3.0%). Hypogylcaemia was reported in two (vildagliptin) and one (placebo) patient.
Vildagliptin is effective and well tolerated as an add-on to glimepiride in Japanese patients with T2DM.
评估维格列汀作为二肽基肽酶-4（DPP-4）抑制剂，在与格列美脲合用时对血糖控制不佳的日本 2 型糖尿病（T2DM）患者的有效性和耐受性。
这是一项为期 12 周、随机、双盲、安慰剂对照的研究，比较了维格列汀 50mg 每日 2 次（n=102）与安慰剂（n=100）联合格列美脲（≥1mg/d）的疗效。
治疗组在基线时（糖化血红蛋白[HbA1c]，7.9%；空腹血糖，163.8mg/dL）具有可比性。治疗期间，维格列汀可使 HbA1c 逐渐下降，但安慰剂组无变化。治疗终点时的调整平均变化值（AMDelta）分别为维格列汀组-1.0±0.1%和安慰剂组-0.1±0.1%（两组间的差值为-1.0±0.1%，P＜0.001）。与安慰剂组相比，更多的维格列汀治疗患者 HbA1c＜6.5%（45% vs. 3%，P＜0.001）。维格列汀组的 AMDelta FPG 为-20.9±2.8mg/dL，安慰剂组为-6.3±2.8mg/dL（两组间的差值为-27.2±3.9mg/dL，P＜0.001）。维格列汀组和安慰剂组报告的不良事件（AE）发生率（59.8% vs. 57.0%）、严重 AE（0% vs. 2.0%）、疑似药物相关 AE（21.6% vs. 23.0%）和因 AE 停药（1.0% vs. 3.0%）相似。各有 2 例（维格列汀）和 1 例（安慰剂）患者报告低血糖。
维格列汀作为格列美脲的附加疗法，对日本 T2DM 患者有效且耐受性良好。
