Cai Xiao-Ling, Chen Ying-Li, Zhao Jia-Jun, Shan Zhong-Yan, Qiu Ming-Cai, Li Cheng-Jiang, Gu Wei, Tian Hao-Ming, Yang Hua-Zhang, Xue Yao-Ming, Yang Jin-Kui, Hong Tian-Pei, Ji Li-Nong
Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing 100044, China.
Chin Med J (Engl). 2015 May 20;128(10):1279-87. doi: 10.4103/0366-6999.156735.
At present, China has listed the compound tablet containing a fixed dose of rosiglitazone and metformin, Avandamet, which may improve patient compliance. The aim of this study was to evaluate the efficacy and safety of Avandamet or uptitrated metformin treatment in patients with type 2 diabetes inadequately controlled with metformin alone.
This study was a 48-week, multicenter, randomized, open-labeled, active-controlled trial. Patients with inadequate glycaemic control (glycated hemoglobin [HbA1c] 7.5-9.5%) receiving a stable dose of metformin (≥1500 mg) were recruited from 21 centers in China (from 19 November, 2009 to 15 March, 2011). The primary objective was to compare the proportion of patients who reached the target of HbA1c ≤7% between Avandamet and metformin treatment.
At week 48, 83.33% of patients reached the target of HbA1c ≤7% in Avandamet treatment and 70.00% in uptitrated metformin treatment, with significantly difference between groups. The target of HbA1c ≤6.5% was reached in 66.03% of patients in Avandamet treatment and 46.88% in uptitrated metformin treatment. The target of fasting plasma glucose (FPG) ≤6.1 mmol/L was reached in 26.97% of patients in Avandamet treatment and 19.33% in uptitrated metformin treatment. The target of FPG ≤7.0 mmol/L was reached in 63.16% of patients in Avandamet treatment and 43.33% in uptitrated metformin treatment. Fasting insulin decreased 3.24 ± 0.98 μU/ml from baseline in Avandamet treatment and 0.72 ± 1.10 μU/ml in uptitrated metformin treatment. Overall adverse event (AE) rates and serious AE rates were similar between groups. Hypoglycaemia occurred rarely in both groups.
Compared with uptitrated metformin, Avandamet treatment provided significant improvements in key parameters of glycemic control and was generally well tolerated.
ChiCTR-TRC-13003776.
目前，中国已上市含固定剂量罗格列酮和二甲双胍的复方片剂（文达敏），这可能会提高患者的依从性。本研究的目的是评估文达敏或滴定剂量的二甲双胍治疗对仅使用二甲双胍血糖控制不佳的2型糖尿病患者的疗效和安全性。
本研究是一项为期48周的多中心、随机、开放标签、活性对照试验。从中国21个中心（2009年11月19日至2011年3月15日）招募血糖控制不佳（糖化血红蛋白[HbA1c]7.5 - 9.5%）且接受稳定剂量二甲双胍（≥1500 mg）的患者。主要目的是比较文达敏治疗组和二甲双胍治疗组中达到HbA1c≤7%目标的患者比例。
在第48周时，文达敏治疗组83.33%的患者达到HbA1c≤7%的目标，滴定剂量的二甲双胍治疗组为70.00%，两组间差异有统计学意义。文达敏治疗组66.03%的患者达到HbA1c≤6.5%的目标，滴定剂量的二甲双胍治疗组为46.88%。文达敏治疗组26.97%的患者达到空腹血糖（FPG）≤6.1 mmol/L的目标，滴定剂量的二甲双胍治疗组为19.33%。文达敏治疗组63.16%的患者达到FPG≤7.0 mmol/L的目标，滴定剂量的二甲双胍治疗组为43.33%。文达敏治疗组空腹胰岛素水平较基线下降3.24±0.98 μU/ml，滴定剂量的二甲双胍治疗组下降0.72±1.10 μU/ml。两组总体不良事件（AE）发生率和严重AE发生率相似。两组低血糖发生率均较低。
与滴定剂量的二甲双胍相比，文达敏治疗在血糖控制关键指标上有显著改善，且总体耐受性良好。
ChiCTR - TRC - 13003776
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