title: Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: results from the A₁chieve study.
abstract: OBJECTIVE
  This A1chieve® study subgroup analysis examined clinical safety and effectiveness of biphasic insulin aspart 30 (BIAsp30) ±OGLDs in 6323 individuals with T2D, switching from biphasic human insulin 30 (BHI30) ±OGLDs.
  
  
  METHODS
  A1chieve was a 24-week, international, prospective, observational, multi-centre, open-label study in individuals with T2D starting treatment with BIAsp30, insulin detemir or insulin aspart as part of routine clinical care.
  
  
  RESULTS
  Mean baseline (SD) dose BHI was 0.56 (0.25) IU/kg. BIAsp30 was initiated at 0.57 (0.25) U/kg; the daily dose was 0.62 (0.28)U/kg by Week 24. Switching from BHI30 to BIAsp30 was associated with significant mean reduction in HbA1c of 1.7% [-18 mmol/mol] (1.6) from a baseline of 9.1% [76 mmol/mol] (p<0.001); FPG and PPG were also significantly reduced (p<0.001). Major hypoglycaemic episodes decreased from 0.69 events/patient/year at baseline to 0.03 events/patient/year at Week 24. Minor hypoglycaemia decreased from 5.31 to 2.04 events/patient/year from baseline to study-end. Five serious adverse drug reactions (hypoglycaemia) were reported by five individuals (0.1%). Mean bodyweight increased by 0.1 (3.3)kg from baseline to 24 weeks. Improved self-reported quality of life was observed.
  
  
  CONCLUSIONS
  Switching from BHI30 to BIAsp30 in individuals with T2D is associated with improvement in glycaemic control and reduced rates of hypoglycaemia, without tolerability or safety issues.
authors.affiliation: Hai Al Jamea Hospital, Jeddah, Jeddah 21433, The Kingdom of Saudi Arabia. nelnaggar@yahoo.com
authors.forename: Nabil K
authors.initials: NK
authors.lastname: El Naggar
authors.forename: Pradana
authors.initials: P
authors.lastname: Soewondo
authors.forename: Mohammad E
authors.initials: ME
authors.lastname: Khamseh
authors.forename: Jian-Wen
authors.initials: JW
authors.lastname: Chen
authors.forename: Jihad
authors.initials: J
authors.lastname: Haddad
mesh_terms: D000328:Adult; D000352:Africa, Northern; D000368:Aged; D001208:Asia; D061265:Biphasic Insulins / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004338:Drug Combinations; D016903:Drug Monitoring; D005260:Female; D006442:Glycated Hemoglobin; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000517:prevention & control*; 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*; D008297:Male; D008875:Middle Aged; D008877:Middle East; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D061265:Biphasic Insulins; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D007336:Insulin, Isophane; C575870:biphasic human insulin 30; C517652:hemoglobin A1c protein, human; C557564:insulin aspart, insulin aspart protamine drug combination 30:70