title: Biphasic insulin aspart 30 as insulin initiation or replacement therapy: the China cohort of the IMPROVE study.
abstract: OBJECTIVE
  To explore safety and efficacy of BIAsp 30 as initiation or replacement therapy in routine clinical practice in patients with poorly controlled diabetes in the Chinese cohort of the IMPROVE study.
  
  
  METHODS
  In the 26-week, non-interventional, observational study, Chinese subjects with diabetes started BIAsp 30 treatment in routine care. Data from patients' diaries and medical records were transferred to CRFs by participating physicians.
  
  
  BACKGROUND
  NCT00659282.
  
  
  RESULTS
  Of the 21,729 subjects enrolled (mean age 54.0 years, BMI 24.6 kg/m 2 , diabetes duration 4.86 years), 32.3% were treatment-naïve, 59.3% were from oral anti-diabetic drugs (OADs) only and 8.1% were from insulin +/- OADs. Overall, mean HbA(1c) and FBG decreased by 2.82% and 5 mmol/L, respectively. In the subgroups, changes were: -3.27% and -6.06 mmol/L (treatment-naïve), -2.57% and -4.54 mmol/L (OADs only), -2.96% and 3.51 mmol/L (insulin +/- OADs) all p < 0.05. HbA(1c) < 7% was achieved by 71.4% of patients. Only 0.1% of subjects reported major hypoglycaemia and 73 SADRs were observed without significant difference compared to those at baseline. Body weight did not change significantly.
  
  
  CONCLUSIONS
  Regardless of previous treatments, insulin initiation or replacement with BIAsp 30 improved glycaemic control without increasing major hypoglycaemia or weight gain in Chinese patients with diabetes.
authors.affiliation: China-Japan Friendship Hospital, Beijing, China. yangwenying1707@yahoo.com.cn
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
authors.forename: Yan
authors.initials: Y
authors.lastname: Gao
authors.forename: Guoliang
authors.initials: G
authors.lastname: Liu
authors.forename: Lulu
authors.initials: L
authors.lastname: Chen
authors.forename: Zuzhi
authors.initials: Z
authors.lastname: Fu
authors.forename: Dajin
authors.initials: D
authors.lastname: Zou
authors.forename: Ping
authors.initials: P
authors.lastname: Feng
authors.forename: Zhigang
authors.initials: Z
authors.lastname: Zhao
mesh_terms: D061265:Biphasic Insulins; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061267:Insulin Aspart; D007336:Insulin, Isophane; D017060:Patient Satisfaction; D011788:Quality of Life; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
chemical_list: D061265:Biphasic Insulins; D007004:Hypoglycemic Agents; D007328:Insulin; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; D007336:Insulin, Isophane; D061267:Insulin Aspart