title: [The efficacy and safety of recombinant human insulin injection in the treatment of diabetic patients:a multicenter, randomized, controlled and open-labeled clinical trial].
abstract: OBJECTIVE
  A multicenter, randomized, controlled and open-labeled clinical trial was performed to compare the efficacy and safety of recombinant human insulin injection (Yousilin R) and Novolin R in diabetic patients.
  
  
  METHODS
  A total of 211 cases were randomized into two groups (1:1) treated with Yousilin R versus Novolin R for 12 weeks respectively.
  
  
  RESULTS
  Compared with baseline, the levels of glycosylated hemoglobin A1c (HbA1c) at the end of 12 weeks treatment decreased from 10.77% to 7.72%(P < 0.05) in Yousilin R group and from 10.33% to 7.62% (P < 0.05) in Novolin R group, 2-hour postprandial plasma glucose (2hPG) decreased from 15.49 mmol/L to 9.72 mmol/L (P < 0.05) in Yousilin R group and from 15.33 mmol/L to 10.07 mmol/L (P < 0.05) in Novolin R group, and fasting plasma glucose (FPG) decreased from 10.90 mmol/L to 7.31 mmol/L (P < 0.05) in Yousilin R group and from 10.22 mmol/L to 7.21 mmol/L (P < 0.05) in Novolin R group. The changes of HbA1c, 2hPG and FPG from baseline to endpoint in Yousilin R group was similar to those in Novolin R group (P > 0.05). Furthermore, hypoglycemic events (26.42% vs 30.48%), other adverse events (13.21% vs 16.19%), and serious adverse events (1.89% vs 1.90%) were comparable between Yousilin R and Novolin R groups (P > 0.05).
  
  
  CONCLUSIONS
  Yousilin R has similar efficacy, safety and compliance profiles to Novolin R group in the treatment of diabetic patients.
authors.affiliation: West China Hospital of sichuan University, Chengdu, China.
authors.forename: Ting-ting
authors.initials: TT
authors.lastname: Che
authors.forename: Xi
authors.initials: X
authors.lastname: Wang
authors.forename: Yuan-yuan
authors.initials: YY
authors.lastname: Liu
authors.forename: Hao-ming
authors.initials: HM
authors.lastname: Tian
authors.forename: Gang-yi
authors.initials: GY
authors.lastname: Yang
authors.forename: Mian
authors.initials: M
authors.lastname: Xu
authors.forename: Chang-qing
authors.initials: CQ
authors.lastname: Xiao
authors.forename: Lü-yun
authors.initials: LY
authors.lastname: Zhu
authors.forename: Xiao-feng
authors.initials: XF
authors.lastname: Lü
authors.forename: Hong-ling
authors.initials: HL
authors.lastname: Yu
authors.forename: Xiang-xun
authors.initials: XX
authors.lastname: Zhang
authors.forename: Yan
authors.initials: Y
authors.lastname: Ren
mesh_terms: D000328:Adult; D003920:Diabetes Mellitus / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D015203:Reproducibility of Results
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D011994:Recombinant Proteins