Polyethylene glycol loxenatide injections added to metformin effectively improve glycemic control and exhibit favorable safety in type 2 diabetic patients
机构：[1]Department of Endocrinology, China–Japan Friendship Hospital, Beijing, China[2]General Hospital of Beijing Military Region, Beijing, China[3]Beijing Tongren Hospital, Capital Medical University, Beijing, China首都医科大学附属北京同仁医院首都医科大学附属同仁医院[4]Department of Endocrinology, Xiehe Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China[5]Department of Physical Exam Center, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China[6]Department of Physical Exam Center, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China重庆医科大学附属第一医院[7]Academy of Traditional Chinese Medicine Sciences, Jilin, China[8]Changchun University of Traditional Chinese Medicine, Changchun, China[9]Department of Endocrinology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China[10]The Second Affiliated Hospital of Traditional Chinese Medicine, Dalian, China[11]Department of Endocrinology, The 2nd Affiliated Hospital, Soochow University, Suzhou, China[12]Taihe Hospital, Shiyan, China[13]Department of Endocrinology, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China中山大学附属第一医院[14]The Third Hospital of Hebei Medical University, Shijiazhuang, China[15]Siping Central People’s Hospital, Siping, China[16]Department of Endocrinology and Metabolism, The Second Hospital, Tianjin Medical University, Tianjin, China[17]Department of Endocrinology, Shanghai Jiaotong University Affiliated First People’s Hospital, Shanghai, China
BackgroundThe aim of the present study was to evaluate the efficacy and safety of polyethylene glycol loxenatide (PEX168) injections in Chinese type 2 diabetic (T2D) patients. MethodsThe present multicenter randomized double-blind parallel placebo-controlled clinical trial enrolled patients who had been treated with a stable dose of metformin (1500mg/day) for 12weeks and had an HbA1c level between 7% and 11%. Subjects were randomly divided into three groups (1:1:1) and were treated with once weekly subcutaneous injections of either placebo or 100 or 200g PEX168 for 12weeks. All subjects continued to receive metformin daily. ResultsAfter 12weeks treatment, the adjusted least-squares mean of HbA1c reductions from baseline values in the 100 and 200g PEX168 groups were significantly higher than in the placebo group (-1.02% [95% confidence interval {CI} -1.33, -0.71), -1.36% [95% CI -1.68, -1.04], and 0.13% [95% CI -0.20, 0.45], respectively; P<0.05). After treatment, 50% and 60.5% of subjects in the 100 and 200g PEX168 groups, respectively, achieved HbA1c levels <7% (P<0.01 for both vs placebo [HbA1c 11.1%]). The most frequent adverse reactions in the PEX168 groups were mild to moderate dose-dependent gastrointestinal reactions. There were no reports of hypoglycemia or pancreatitis in any of the groups. ConclusionsContinuous 12week treatment with PEX168 showed excellent safety and efficacy in T2D patients whose glucose was not well controlled with metformin alone.
第一作者机构：[1]Department of Endocrinology, China–Japan Friendship Hospital, Beijing, China
通讯作者：
通讯机构：[1]Department of Endocrinology, China–Japan Friendship Hospital, Beijing, China[*1]Department of Endocrinology, China-Japan Friendship Hospital, 2 Yinghua Dongjie, Hepingli, Beijing 100029, China
推荐引用方式(GB/T 7714)：
Chen Xiaoping,Lv Xiaofeng,Yang Gangyi,et al.Polyethylene glycol loxenatide injections added to metformin effectively improve glycemic control and exhibit favorable safety in type 2 diabetic patients[J].JOURNAL OF DIABETES.2017,9(2):158-167.doi:10.1111/1753-0407.12397.
APA：
Chen, Xiaoping,Lv, Xiaofeng,Yang, Gangyi,Lu, Dan,Piao, Chunli...&Yang, Wenying.(2017).Polyethylene glycol loxenatide injections added to metformin effectively improve glycemic control and exhibit favorable safety in type 2 diabetic patients.JOURNAL OF DIABETES,9,(2)
MLA：
Chen, Xiaoping,et al."Polyethylene glycol loxenatide injections added to metformin effectively improve glycemic control and exhibit favorable safety in type 2 diabetic patients".JOURNAL OF DIABETES 9..2(2017):158-167
