title: Clinical use and efficacy of biphasic insulin lispro 50/50 in people with insulin treated diabetes - a nationwide evaluation of clinical practice.
abstract: OBJECTIVE
  This study aims to investigate the metabolic effects of biphasic insulin lispro 50/50 in routine clinical practice. A total of 229 patients who were ≥18 years old with diabetes, newly treated with biphasic insulin lispro 50/50, were sourced from six secondary care services in England.
  
  
  METHODS
  Detailed clinical parameters were compared at baseline, and 3 and 6 months post-initiation. Responders was defined as those with HbA1c <7.5% (58 mmol/mol) and/or an HbA1c reduction of >1% (11 mmol/mol) at 6 months.
  
  
  RESULTS
  HbA1c showed significant reduction: -0.93% (-10 mmol/mol) and -1.2% (-13 mmol/mol) at 3 and 6 months respectively, while no significant change was noted for all the other parameters. When analyzed according to frequencies of injections/day, the greatest reduction was observed with the three times a day regimen (-1.0% [-11.0 mmol/mol] and -1.3% [-14.6 mmol/mol] at 3 and 6 months respectively). HbA1c reduction was greatest in the group who previously received a basal-bolus insulin regimen: (-0.8% [-9.0 mmol/mol] and -1.5% [-16.2 mmol/mol] at 3 and 6 months respectively). Reduction in weight was observed at 3 months (-1.8 kg ± 4.3) only for those who were previously on a basal-bolus insulin regimen. Insulin doses increased following conversion to biphasic insulin lispro 50/50, irrespective of the types of insulin used prior to biphasic insulin lispro 50/50, but this was not associated with weight gain. The independent predictors of response to biphasic insulin lispro 50/50 were baseline HbA1c, Caucasian, presence of nephropathy, prior use of basal-bolus insulin and prior use of other premixed combination.
  
  
  CONCLUSIONS
  Biphasic insulin lispro 50/50 is therefore an effective therapeutic option for achieving glycemic control in patients with suboptimal HbA1c levels, especially among those who were previously on a basal-bolus insulin regimen and those who received it three times daily, with a neutral effect on weight parameters.
  
  
  CONCLUSIONS
  This was a retrospective study of routine clinical practice and is therefore limited by allocation bias and some missing data. Information on rates of hypoglycemia and quality of life are not available.
authors.affiliation: Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham , UK.
authors.forename: N K
authors.initials: NK
authors.lastname: Mungreiphy
authors.forename: J
authors.initials: J
authors.lastname: Mamza
authors.forename: A F
authors.initials: AF
authors.lastname: Lakhdar
authors.forename: M
authors.initials: M
authors.lastname: Bannister
authors.forename: J
authors.initials: J
authors.lastname: Elliott
authors.forename: I
authors.initials: I
authors.lastname: Idris
mesh_terms: D000328:Adult; D000368:Aged; D061265:Biphasic Insulins / Q000008:administration & dosage / Q000009:adverse effects; D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy / Q000523:psychology; D016903:Drug Monitoring; D004739:England; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007267:Injections; D061268:Insulin Lispro / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012189:Retrospective Studies; D015430:Weight Gain
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061268:Insulin Lispro
keywords: Biphasic insulin lispro 50/50; HbA1c; Insulin; Routine clinical practice