title: Polyethylene glycol loxenatide injections added to metformin effectively improve glycemic control and exhibit favorable safety in type 2 diabetic patients.
abstract: BACKGROUND
  The 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.
  
  
  METHODS
  The present multicenter randomized double-blind parallel placebo-controlled clinical trial enrolled patients who had been treated with a stable dose of metformin (≥1500 mg/day) for ≥12 weeks 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 200 μg PEX168 for 12 weeks. All subjects continued to receive metformin daily.
  
  
  RESULTS
  After 12 weeks treatment, the adjusted least-squares mean of HbA1c reductions from baseline values in the 100 and 200 μg 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 200 μg 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.
  
  
  CONCLUSIONS
  Continuous 12 week treatment with PEX168 showed excellent safety and efficacy in T2D patients whose glucose was not well controlled with metformin alone.
authors.affiliation: Department of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Chen
authors.affiliation: General Hospital of Beijing Military Region, Beijing, China.
authors.forename: Xiaofeng
authors.initials: X
authors.lastname: Lv
authors.affiliation: Department of Physical Exam Center, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.
authors.forename: Gangyi
authors.initials: G
authors.lastname: Yang
authors.affiliation: Academy of Traditional Chinese Medicine Sciences, Jilin, China.
authors.forename: Dan
authors.initials: D
authors.lastname: Lu
authors.affiliation: Changchun University of Traditional Chinese Medicine, Changchun, China.
authors.forename: Chunli
authors.initials: C
authors.lastname: Piao
authors.affiliation: Department of Endocrinology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
authors.forename: Xiaomei
authors.initials: X
authors.lastname: Zhang
authors.affiliation: The Second Affiliated Hospital of Traditional Chinese Medicine, Dalian, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Jiang
authors.affiliation: Department of Endocrinology, The 2nd Affiliated Hospital, Soochow University, Suzhou, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Xie
authors.affiliation: Beijing Tongren Hospital, Capital Medical University, Beijing, China.
authors.forename: Jinkui
authors.initials: J
authors.lastname: Yang
authors.affiliation: Taihe Hospital, Shiyan, China.
authors.forename: Xuefeng
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Endocrinology, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
authors.forename: Yanbing
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Endocrinology, Xiehe Hospital, Peking Union Medical College, Chinese Academy of Medical Science, Beijing, China.
authors.forename: Xinhua
authors.initials: X
authors.lastname: Xiao
authors.affiliation: The Third Hospital of Hebei Medical University, Shijiazhuang, China.
authors.forename: Yukun
authors.initials: Y
authors.lastname: Li
authors.affiliation: Siping Central People's Hospital, Siping, China.
authors.forename: Li
authors.initials: L
authors.lastname: Sun
authors.affiliation: Department of Endocrinology and Metabolism, The Second Hospital, Tianjin Medical University, Tianjin, China.
authors.forename: Shaoxiong
authors.initials: S
authors.lastname: Zheng
authors.affiliation: Department of Physical Exam Center, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China.
authors.forename: Qingfeng
authors.initials: Q
authors.lastname: Cheng
authors.affiliation: Department of Endocrinology, Shanghai Jiaotong University Affiliated First People's Hospital, Shanghai, China.
authors.forename: Yongde
authors.initials: Y
authors.lastname: Peng
authors.affiliation: Department of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
mesh_terms: D000328:Adult; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010455:Peptides; D011092:Polyethylene Glycols; C000601947:polyethylene glycol loxenatide
keywords: clinical trial; diabetes mellitus; glucagon-like peptide-1 receptor agonist; polyethylene glycol loxenatide injection