title: Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN cohort of the A₁chieve study.
abstract: OBJECTIVE
  To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in the ASEAN cohort of the A₁chieve study.
  
  
  METHODS
  Type 2 diabetes patients from Indonesia, Malaysia, Philippines and Singapore prescribed BIAsp 30 therapy were included. The primary outcome was evaluation of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary outcomes were changes in hypoglycaemic events, serious adverse events (SAEs) and effectiveness parameters.
  
  
  RESULTS
  This sub-analysis included 2798 patients (insulin-naive, 1903; insulin-experienced, 895) with mean age ± SD, 55.3 ± 10.8 years, BMI, 24.9 ± 4.6 kg/m(2) and diabetes duration, 7.5 ± 5.9 years. Baseline HbA1c in the entire cohort was poor (9.9%, 85 mmol/mol). A total of 15 SAEs were reported in 7 insulin-experienced patients (1 moderate event was related to BIAsp 30). Overall hypoglycaemia at Week 24 was 0.88 events/patient-year compared to 1.71 events/patient-year reported at baseline (change in proportion of patients affected, p < 0.0001). No major hypoglycaemia was reported at Week 24. BIAsp 30 significantly improved glucose control (HbA1c, fasting plasma glucose and postprandial plasma glucose, p < 0.001) at Week 24. The proportion of patients achieving HbA1c <7.0% at Week 24 was 35.3% compared to 3.5% at baseline. The lipid profile and systolic blood pressure also improved significantly (p < 0.001). Quality of life was positively impacted (mean change in visual analogue scores from EQ-5D = 10.6 ± 13.8 points, p < 0.001).
  
  
  CONCLUSIONS
  BIAsp 30 was well-tolerated and improved glucose control while decreasing the risk of hypoglycaemia.
authors: University of the Philippines College of Medicine, Manila, Philippines. docmalim@gmail.com
authors: Mary Anne
authors: MA
authors: Lim-Abrahan
authors: Anand B
authors: AB
authors: Jain
authors: Wan Mohamad Wan
authors: WM
authors: Bebakar
authors: Darren
authors: D
authors: Seah
authors: Pradana
authors: P
authors: Soewondo
mesh_terms: D000328:Adult; D000368:Aged; D001210:Asia, Southeastern / Q000453:epidemiology; D044466:Asian People; D015415:Biomarkers / Q000097:blood; D061265:Biphasic Insulins / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D001794:Blood Pressure / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology / Q000401:mortality; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D061267:Insulin Aspart / Q000009:adverse effects / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011788:Quality of Life; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
chemical_list: D015415:Biomarkers; D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D007336:Insulin, Isophane; D008055:Lipids; C517652:hemoglobin A1c protein, human; C557564:insulin aspart, insulin aspart protamine drug combination 30:70