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

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 A(1)chieve 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. HbA(1c) improved from 8.8 +/- 1.2% at baseline to 7.3 +/- 0.8% at Week 24. A total of 45 patients achieved HbA(1c) <7.0% as compared to 5 patients with HbA(1c) <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. (C) 2013 Elsevier Ireland Ltd. All rights reserved.