title: Clinical safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30: results from the Indonesian cohort of the A₁chieve study.
abstract: OBJECTIVE
  To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Indonesian type 2 diabetes patients switched from biphasic human insulin 30 (BHI 30) as a sub-analysis of the A₁chieve study.
  
  
  METHODS
  Clinical safety and effectiveness over 24 weeks was evaluated in Indonesian patients who switched from BHI 30 to BIAsp 30 at the discretion of their physician.
  
  
  RESULTS
  A total of 244 patients with mean age ± SD 55.6 ± 9.5 years, BMI 24.6 ± 3.8 kg/m(2), and mean diabetes duration 7.8 ± 5.7 years were included. The mean pre-study BHI 30 dose was 0.56 ± 0.25 IU/kg and the baseline BIAsp 30 dose was 0.60 ± 0.26 U/kg titrated up to 0.65 ± 0.25 U/kg by Week 24. No serious adverse drug reactions were reported throughout the study. Overall hypoglycaemia decreased from 2.18 to 0.06 events/patient-year with a significant decrease in the proportion of patients affected (p < 0.0001). No nocturnal or major hypoglycaemia was reported at Week 24. HbA1c improved from 8.8 ± 1.2% at baseline to 7.3 ± 0.8% at Week 24. A total of 45 patients achieved HbA1c <7.0% as compared to 5 patients with HbA1c <7.0% at baseline. FPG and PPPG improved significantly after 24 weeks (p < 0.001). Quality of life was positively impacted (change in visual analogue scores, 3.0 ± 11.6 points, p < 0.001).
  
  
  CONCLUSIONS
  Switching from BHI 30 to BIAsp 30 in this Indonesian cohort was well-tolerated and improved glycaemic control with a decreased risk of hypoglycaemia.
authors: University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia. Electronic soewondops@yahoo.com
authors: Pradana
authors: P
authors: Soewondo
authors: Dharma
authors: D
authors: Lindarto
authors: Sony
authors: S
authors: Wibisono
authors: Olly
authors: O
authors: Renaldi
authors: Tjokorda Gde
authors: TG
authors: Dalem-Pemayun
mesh_terms: D000368:Aged; 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; D004338:Drug Combinations; D057915:Drug Substitution; 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*; D007214:Indonesia / Q000453:epidemiology; 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; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D007336:Insulin, Isophane; D008055:Lipids; C575870:biphasic human insulin 30; C517652:hemoglobin A1c protein, human; C557564:insulin aspart, insulin aspart protamine drug combination 30:70