title: Multicenter, open-label, non-randomized, non-interventional observational study of safety of treatment initiation with a biphasic insulin aspart.
abstract: BACKGROUND
  Type 2 diabetes mellitus is characterized by hyperglycaemia. Incidence and progression of microvascular complications have been shown to undergo reduction with lowered glucose levels.
  
  
  METHODS
  This is an open-label, non-randomized, non-interventional, observational study of safety and efficacy of BiAsp 30, enrolling 2223 patients with type 2 diabetes mellitus. Patients previously treated with oral antidiabetic drugs and/or human insulin were recruited, provided they had been hospitalized for at least 3 days. Data were collected during a single multi-stage visit lasting up to 6 days, during the patient's hospitalization period. A mild hypoglycaemic episode was defined as blood glucose measurement < 56 mg/dL (3.1 mmol/L). A severe hypoglycaemia was hypoglycaemic episode requiring assistance of another person.
  
  
  RESULTS
  The total number of hypoglycaemic episodes decreased over time of follow-up. The intensity of severe hypoglycaemic episodes decreased by almost a third from day to day (IRR = 0.64, 95%, p < 0.001). However, intensity of mild hypoglycaemic episodes was the same over the subsequent days of follow-up (IRR = 0.97, p > 0.1). Mean blood glucose concentration decreased from 202.0 mg/dL to 157.8 mg/dL after 3 days and to 138.3 mg/dL after 6 days (p < 0.001).
  
  
  CONCLUSIONS
  This study highlights the safety, efficacy and ease of initiation of insulin BiAsp 30 therapy for treatment of type 2 diabetes mellitus.
authors.affiliation: Medical University of Gdańsk, Department of Hypertension and Diabetology, Debinki 7, 80-211 Gdansk, Poland. bwolnik@gumed.edu.pl
authors.forename: Bogumił
authors.initials: B
authors.lastname: Wolnik
authors.forename: Lukasz
authors.initials: L
authors.lastname: Hak
mesh_terms: D061265:Biphasic Insulins / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization / Q000639:trends*; 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*; D008297:Male; D016896:Treatment Outcome
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D007004:Hypoglycemic Agents; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; D007336:Insulin, Isophane; D061267:Insulin Aspart