title: Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial.
abstract: OBJECTIVE
  The present study was to compare the efficacy and safety of subject-driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID).
  
  
  METHODS
  In this 20-week, randomized, open-label, two-group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self-mixed human insulin were randomized 1:1 to subject-driven or investigator-driven titration of BIAsp 30 BID, in combination with metformin and/or α-glucosidase inhibitors. Dose adjustment was decided by patients in the subject-driven group after training, and by investigators in the investigator-driven group.
  
  
  RESULTS
  Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject-driven group and 14.3 mmol/mol (1.31%) in the investigator-driven group. Non-inferiority of subject-titration vs investigator-titration in reducing HbA1c was confirmed, with estimated treatment difference -0.26 mmol/mol (95% confidence interval -2.05, 1.53) (-0.02%, 95% confidence interval -0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self-measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient-year) was reported in the subject-driven (1.10) and investigator-driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c <53.0 mmol/mol (7.0%), and 51.2 and 45.9% patients achieving the HbA1c target without confirmed hypoglycemia throughout the trial in the subject-driven and investigator-driven groups, respectively.
  
  
  CONCLUSIONS
  Subject-titration of BIAsp 30 BID was as efficacious and well-tolerated as investigator-titration. The present study supported patients to self-titrate BIAsp 30 BID under physicians' supervision.
authors.affiliation: China-Japan Friendship Hospital Beijing China.
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
authors.affiliation: Bethune International Peace Hospital Shijiazhuang China.
authors.forename: Lvyun
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Affiliated Hospital of Inner Mongolia University for the Nationalities Tongliao China.
authors.forename: Bangzhu
authors.initials: B
authors.lastname: Meng
authors.affiliation: The Second Hospital of Jilin University Changchun China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Jinan Central Hospital Affiliated to Shandong University Jinan China.
authors.forename: Wenhui
authors.initials: W
authors.lastname: Wang
authors.affiliation: Anhui Provincial Hospital Hefei China.
authors.forename: Shandong
authors.initials: S
authors.lastname: Ye
authors.affiliation: Siping Central People's Hospital Siping China.
authors.forename: Li
authors.initials: L
authors.lastname: Sun
authors.affiliation: The Second Affiliated Hospital of Nanjing Medical University Nanjing China.
authors.forename: Heng
authors.initials: H
authors.lastname: Miao
authors.affiliation: Chongqing Three Gorges Central Hospital Chongqing China.
authors.forename: Lian
authors.initials: L
authors.lastname: Guo
authors.affiliation: The Third Affiliated Hospital of Hebei Medical University Shijiazhuang China.
authors.forename: Zhanjian
authors.initials: Z
authors.lastname: Wang
authors.affiliation: The Military General Hospital of Beijing PLA Beijing China.
authors.forename: Xiaofeng
authors.initials: X
authors.lastname: Lv
authors.affiliation: The Second Artillery General Hospital of Chinese PLA Beijing China.
authors.forename: Quanmin
authors.initials: Q
authors.lastname: Li
authors.affiliation: Xijing Hospital Affiliated to 4th Military Medical University Xi'an China.
authors.forename: Qiuhe
authors.initials: Q
authors.lastname: Ji
authors.affiliation: Peking Union Medical College Hospital Beijing China.
authors.forename: Weigang
authors.initials: W
authors.lastname: Zhao
authors.affiliation: The Second Affiliated Hospital of Chongqing Medical University Chongqing China.
authors.forename: Gangyi
authors.initials: G
authors.lastname: Yang
mesh_terms: D000328:Adult; D044466:Asian People; D061265:Biphasic Insulins / Q000008:administration & dosage*; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002681:China / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D061267:Insulin Aspart / Q000008:administration & dosage*; D007336:Insulin, Isophane / Q000008:administration & dosage*; D061386:Insulin, Regular, Human / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D012108:Research Personnel; D035842:Research Subjects
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D061386:Insulin, Regular, Human; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; D007336:Insulin, Isophane; D061267:Insulin Aspart
keywords: Biphasic insulin aspart; Titration; Type 2 diabetes
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