China-Japan Friendship Hospital, Beijing, China.
J Diabetes. 2012 Sep;4(3):227-37. doi: 10.1111/j.1753-0407.2012.00213.x.
The present study was conducted to evaluate the efficacy, safety and tolerability of sitagliptin added to ongoing metformin therapy in Chinese patients with type 2 diabetes (T2DM) who failed to achieve adequate glycemic control with metformin monotherapy.
After a metformin titration/stabilization period and a 2-week, single-blind, placebo run-in period, 395 Chinese patients with T2DM aged 25-77 years (baseline HbA1c 8.5%) were randomized (1:1) to double-blind placebo or sitagliptin 100 mg q.d. added to ongoing open-label metformin (1000 or 1700 mg/day) for 24 weeks.
Significant (P < 0.001) changes from baseline in HbA1c (-0.9%), fasting plasma glucose (-1.2 mmol/L), and 2-h post-meal plasma glucose (-1.9 mmol/L) were seen with sitagliptin compared with placebo. There were no significant differences between sitagliptin and placebo in the incidence of hypoglycemia or gastrointestinal adverse events. A small decrease from baseline body weight was observed in the placebo group compared with no change in the sitagliptin group (between-group difference 0.5kg; P=0.018).
The addition of sitagliptin 100 mg to ongoing metformin therapy significantly improved glycemic control and was generally well tolerated in Chinese patients with T2DM who had inadequate glycemic control on metformin alone.
本研究旨在评估西格列汀在二甲双胍单药治疗血糖控制不佳的中国 2 型糖尿病（T2DM）患者中的疗效、安全性和耐受性。
在二甲双胍滴定/稳定期和 2 周的单盲、安慰剂导入期后，395 名年龄在 25-77 岁（基线 HbA1c 8.5%）的中国 T2DM 患者按 1:1 随机分为双盲安慰剂或西格列汀 100mg 每日 1 次添加到正在进行的开放标签二甲双胍（1000 或 1700mg/天）治疗 24 周。
与安慰剂相比，西格列汀治疗可显著降低 HbA1c（-0.9%）、空腹血糖（-1.2mmol/L）和餐后 2 小时血糖（-1.9mmol/L）（均 P<0.001）。西格列汀与安慰剂在低血糖或胃肠道不良事件的发生率方面无显著差异。与西格列汀组相比，安慰剂组的体重从基线略有下降（组间差异 0.5kg；P=0.018）。
在二甲双胍单药治疗血糖控制不佳的中国 T2DM 患者中，添加西格列汀 100mg 可显著改善血糖控制，且通常具有良好的耐受性。
