title: Safety and effectiveness of biphasic insulin aspart 30 (Biasp 30) in people with type 2 diabetes mellitus in the pakistani population: results from the A1chieve study.
abstract: OBJECTIVE
  To explore the safety and effectiveness of treatment with the insulin analogue, biphasic insulin aspart 30 (BIAsp 30), in people with type 2 diabetes mellitus (T2DM) in a subgroup of a Pakistani population from the A1chieve study.
  
  
  METHODS
  A1chieve was a 24-week, international, prospective, multicentre, open label, observational, non-interventional study designed to evaluate the safety and clinical effectiveness of 66,726 people with T2DM who were initiated with basal insulin detemir, fast actinginsulin aspart, and BIAsp 30 (30% soluble insulin aspart, 70% protamine-crystallized insulin aspart). The study was conducted in 28 countries across Asia, Africa, Latin America, and Europe. Here, we report data from a subgroup of 762 people with T2DM from the Pakistani cohort (insulin naïve and insulin users) who were treated withpremix insulin (BIAsp 30) +/- oral antidiabetic drugs (OADs).
  
  
  RESULTS
  The decrease in HbAlc at week 24 was statistically significant in the entire cohort, the insulin naïve, and insulin users (1.7 +/- 1.1%, 1.8 +/- 1.3% and 1.7 +/- 0.9%, respectively, p<0.001 for all).There was a statistically significant decrease in the mean fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) from baseline toweek 24 in the entire cohort, in the insulin naïve and in the insulin users with BIAsp 30 treatment (p<0.001 for all).No major hypoglycaemic events were reported during the entire study period. There was a statistically significant decrease in the systolic blood pressure (SBP) in all groups (p<0.001). The improvement in the quality of life score (QoL)was statistically significant in all groups (p<0.001 for all).
  
  
  CONCLUSIONS
  BIAsp 30 treatment appeared to be well tolerated and effective as indicated byimproved glycaemiccontrol and QoL in people with T2DM in the Pakistani population after 24 weeks.
authors.affiliation: Department of Diabetes, Diabetic Institute of Pakistan, 71 Jail Road, Lahore. imtiaz_hasan@holmail.com
authors.forename: Mohammad Imtiaz
authors.initials: MI
authors.lastname: Hassan
authors.forename: Azizul Hasan
authors.initials: AH
authors.lastname: Aamir
authors.forename: Zahid
authors.initials: Z
authors.lastname: Miyan
authors.forename: Laiq Ahmed
authors.initials: LA
authors.lastname: Siddiqui
authors.forename: Muhammad Saleem
authors.initials: MS
authors.lastname: Qureshi
authors.forename: Muhammad Zaman
authors.initials: MZ
authors.lastname: Shaikh
mesh_terms: D000328:Adult; D001682:Biological Availability; D061265:Biphasic Insulins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000523:psychology; D004341:Drug Evaluation; D016903:Drug Monitoring / Q000379:methods / Q000706:statistics & numerical data; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D061267:Insulin Aspart / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D010154:Pakistan / Q000453:epidemiology; D060735:Pharmacovigilance; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D002784:Cholesterol; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D007336:Insulin, Isophane; C557564:insulin aspart, insulin aspart protamine drug combination 30:70