title: Efficacy and safety of biphasic insulin aspart 30/70 in the treatment of patients with type 2 diabetes mellitus.
abstract: OBJECTIVE
  To assess the safety and efficacy of biphasic insulin aspart 30/70 in patients with type 2 diabetes mellitus (DM2).
  
  
  METHODS
  We performed an observational, multicenter, prospective study in 3,054 DM2 patients from primary care and specialized settings, treated with biphasic insulin aspart 30/70 (started within 15 days prior to inclusion). In all patients,the following information was available before starting insulin treatment: HbA(1c) levels, fasting plasma glucose (FPG), 4-point glucose profile (before and 90 minutes after breakfast and dinner) and number of hypoglycemic episodes/week. A total of 2,887 patients completed the study (26 ± 1 week). The variables evaluated were rate of adverse events (AE), number of hypoglycemic episodes/week, HbA(1c), FPG and 4-point glucose profile.
  
  
  RESULTS
  At least one AE occurred in 10.7% of the patients (2.3% related to the study drug and 1.4% severe). There was a significant decrease (end of study vs baseline; p < 0.0001 for all the comparisons) in HbA(1c) (7.3% and 8.9%, respectively), the mean number of minor (0.3/0.5) and major (0.02/0.07) hypoglycemic episodes/week, FPG (145/207 mg/dl) and postprandial glycemia (162/225 mg/dl). The improvement in metabolic control was achieved both in patients previously treated with oral antidiabetic drugs and in those treated with insulin. The number of hypoglycemic episodes decreased in patients previously treated with insulin.
  
  
  CONCLUSIONS
  Treatment with biphasic insulin aspart 30/70 in patients with DM2 improves glycemic control, irrespective of previous treatment, with a low rate of AE and fewer hypoglycemic episodes in patients previously treated with insulin.
authors.affiliation: Servicio de Endocrinología y Nutrición. Hospital Universitario de Valme. Sevilla. España. Electronic address: sduran@duransanz.com.
authors.forename: Santiago
authors.initials: S
authors.lastname: Durán García
authors.forename: Ramiro Antuña
authors.initials: RA
authors.lastname: de Alaiz
authors.forename: Jesús A
authors.initials: JA
authors.lastname: Bayort Fernández
authors.forename: Cristina
authors.initials: C
authors.lastname: Hernández Herrero
authors.forename: Gregorio
authors.initials: G
authors.lastname: Manzano García
authors.forename: Alfonso
authors.initials: A
authors.lastname: Pumar López