Clinical safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30: results from the Indonesian cohort of the A₁chieve study

Diabetes Res Clin Pract. 2013 Apr:100 Suppl 1:S41-6. doi: 10.1016/S0168-8227(13)70009-3.

Abstract

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

Methods: Clinical safety and effectiveness over 24 weeks was evaluated in Indonesian patients who switched from BHI 30 to BIAsp 30 at the discretion of their physician.

Results: A total of 244 patients with mean age ± SD 55.6 ± 9.5 years, BMI 24.6 ± 3.8 kg/m(2), and mean diabetes duration 7.8 ± 5.7 years were included. The mean pre-study BHI 30 dose was 0.56 ± 0.25 IU/kg and the baseline BIAsp 30 dose was 0.60 ± 0.26 U/kg titrated up to 0.65 ± 0.25 U/kg by Week 24. No serious adverse drug reactions were reported throughout the study. Overall hypoglycaemia decreased from 2.18 to 0.06 events/patient-year with a significant decrease in the proportion of patients affected (p < 0.0001). No nocturnal or major hypoglycaemia was reported at Week 24. HbA1c improved from 8.8 ± 1.2% at baseline to 7.3 ± 0.8% at Week 24. A total of 45 patients achieved HbA1c <7.0% as compared to 5 patients with HbA1c <7.0% at baseline. FPG and PPPG improved significantly after 24 weeks (p < 0.001). Quality of life was positively impacted (change in visual analogue scores, 3.0 ± 11.6 points, p < 0.001).

Conclusion: Switching from BHI 30 to BIAsp 30 in this Indonesian cohort was well-tolerated and improved glycaemic control with a decreased risk of hypoglycaemia.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Aged
  • Asian People
  • 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*
  • Indonesia / epidemiology
  • Insulin Aspart / adverse effects
  • Insulin Aspart / therapeutic use*
  • Insulin, Isophane / adverse effects
  • Insulin, Isophane / therapeutic use*
  • Lipids / blood
  • Male
  • Middle Aged
  • Prevalence
  • Quality of Life
  • Retrospective Studies
  • 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