title: Efficacy and safety of saxagliptin monotherapy or added to metformin in Chinese patients with type 2 diabetes mellitus: results from the 24-week, post-marketing SUNSHINE study.
abstract: BACKGROUND
  The aim of the present study was to explore the efficacy and safety of saxagliptin in a large Chinese population with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  In all, 1423 T2DM patients from 92 research centers, either drug naïve or uncontrolled by metformin, were enrolled in this single-arm cohort study; patients were treated with saxagliptin 5 mg once daily for 24 weeks. The primary efficacy endpoint was the change from baseline in HbA1c at 24 weeks in the per-protocol analysis set. Secondary endpoints included the proportion of patients achieving HbA1c <7% and changes from baseline in fasting plasma glucose (FPG) and 2-h postprandial plasma glucose (PPG) concentrations at 24 weeks. Safety endpoints included adverse events (AEs) and the incidence of hypoglycemia.
  
  
  RESULTS
  Among 1210 patients in the per-protocol analysis set, mean HbA1c, FPG and 2-h PPG decreased by 1.61 ± 0.04%, 0.55 ± 0.07 mmol/L, and 2.83  ±  0.27 mmol/L, respectively, at week 24. The proportion of patients achieving HbA1c <7% was 44.1%. No new (previously unreported) AEs occurred. The incidence of serious AEs and hypoglycemia was low (1.8% and 1.2%, respectively). There were no significant differences in efficacy endpoints in subgroup analyses by age, creatinine clearance, body mass index, or treatment background. In elderly patients (≥65 years) and those with mild renal impairment (50 < CCr ≤ 80 mL/min), the incidence of AEs was similar to that of the entire study population.
  
  
  CONCLUSIONS
  Saxagliptin significantly improved glycemic control and was well tolerated in Chinese T2DM patients, including the elderly and patients with mild renal impairment.
authors.affiliation: Ruijin Hospital, Shanghai.
authors.forename: Weiqiong
authors.initials: W
authors.lastname: Gu
authors.affiliation: People's Hospital of Liaoning Province.
authors.forename: Li
authors.initials: L
authors.lastname: Liang
authors.affiliation: Linyi People's Hospital, Linyi.
authors.forename: Shengxiang
authors.initials: S
authors.lastname: Wang
authors.affiliation: The First Affiliated Hospital of Baotou Medical College, Baotou.
authors.forename: Yunzhi
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Hospital 463 of PLA.
authors.forename: Yanxiang
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Fengtian Hospital Affiliated to Shenyang Medical College, Shenyang.
authors.forename: Jian
authors.initials: J
authors.lastname: Tian
authors.affiliation: The Second Affiliated Hospital of Chongqing Medical University.
authors.forename: Gangyi
authors.initials: G
authors.lastname: Yang
authors.affiliation: The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun.
authors.forename: Chunli
authors.initials: C
authors.lastname: Piao
authors.affiliation: Dongguan Guanghua Hospital, Dongguan.
authors.forename: Yuzhong
authors.initials: Y
authors.lastname: Li
authors.affiliation: Tianjin Third Hospital, Tianjin.
authors.forename: Jianmei
authors.initials: J
authors.lastname: Yin
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Xin
authors.affiliation: Chongqing Ninth Hospital, Chongqing.
authors.forename: Xingrong
authors.initials: X
authors.lastname: Tan
authors.affiliation: Ruijin Hospital, Shanghai.
authors.forename: Guang
authors.initials: G
authors.lastname: Ning
authors.affiliation: Ruijin Hospital, Shanghai. wqingw@hotmail.com.
authors.forename: Weiqing
authors.initials: W
authors.lastname: Wang
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004151:Dipeptides / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D004151:Dipeptides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; C517652:hemoglobin A1c protein, human; C502994:saxagliptin
keywords: 2型糖尿病; efficacy; safety; saxagliptin; type 2 diabetes mellitus; 安全性; 沙格列汀; 疗效