Safety and effectiveness of biphasic insulin aspart 30 in a Bangladeshi subgroup of type 2 diabetic patients switched from biphasic human insulin 30: a sub-analysis of the A₁chieve study

Diabetes Res Clin Pract. 2013 Apr:100 Suppl 1:S30-4. doi: 10.1016/S0168-8227(13)70007-X.

Abstract

Aim: To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) therapy in Bangladeshi type 2 diabetes (T2D) patients switched from biphasic human insulin (BHI) as a sub-analysis of the A₁chieve study.

Methods: Bangladeshi patients switched from BHI to BIAsp 30 at the discretion of their physicians were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia. Secondary outcomes comprised changes from baseline to Week 24 in the number of hypoglycaemic events, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), systolic blood pressure and body weight. Quality of life (QoL) was evaluated at baseline and Week 24 using the EQ-5D questionnaire.

Results: A total of 82 patients (mean age ± SD: 52.3 ± 12.2 years; body mass index: 25.6 ± 3.3 kg/m(2)) with a mean diabetes duration of 9.5 ± 5.5 years and mean duration on insulin of 2.5 ± 2.4 years were included. The mean BIAsp 30 dose was 0.49 ± 0.20 U/kg at baseline and 0.47 ± 0.17 U/kg at Week 24. No SADRs were reported. No events of hypoglycaemia (overall, major, minor or nocturnal) were reported at Week 24. Mean HbA1c, FPG and PPPG levels improved by -2.5 ± 1.3%, -65.0 ± 31.8 mg/dL and -119.3 ± 48.7 mg/dL, respectively, over 24 weeks. QoL also improved (mean change from baseline: +28.5 ± 12.9 points).

Conclusion: Switching from BHI to BIAsp 30 therapy improved blood glucose control and was well-tolerated in this Bangladeshi subgroup.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Asian People
  • Bangladesh / epidemiology
  • Biomarkers / blood
  • Biphasic Insulins / adverse effects
  • Biphasic Insulins / therapeutic use*
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism
  • Blood Pressure / drug effects
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / diagnosis
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / ethnology
  • Diabetes Mellitus, Type 2 / mortality
  • Drug Combinations
  • Drug Substitution*
  • Female
  • Glycated Hemoglobin / metabolism
  • Humans
  • Hypoglycemia / blood
  • Hypoglycemia / chemically induced
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Insulin Aspart / adverse effects
  • Insulin Aspart / therapeutic use*
  • Insulin, Isophane / adverse effects
  • Insulin, Isophane / therapeutic use*
  • Lipids / blood
  • Male
  • Middle Aged
  • Prevalence
  • Prospective Studies
  • Quality of Life
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Weight Gain / drug effects

Substances

  • Biomarkers
  • Biphasic Insulins
  • Blood Glucose
  • Drug Combinations
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Lipids
  • biphasic human insulin 30
  • hemoglobin A1c protein, human
  • insulin aspart, insulin aspart protamine drug combination 30:70
  • Insulin, Isophane
  • Insulin Aspart