Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes: Results from the ASEAN cohort of the A1chieve study

Aim: To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in the ASEAN cohort of the A(1)chieve study. Methods: Type 2 diabetes patients from Indonesia, Malaysia, Philippines and Singapore prescribed BIAsp 30 therapy were included. The primary outcome was evaluation of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary outcomes were changes in hypoglycaemic events, serious adverse events (SAEs) and effectiveness parameters. Results: This sub-analysis included 2798 patients (insulin-naive, 1903; insulin-experienced, 895) with mean age +/- SD, 55.3 +/- 10.8 years, BMI, 24.9 +/- 4.6 kg/m(2) and diabetes duration, 7.5 +/- 5.9 years. Baseline HbA(1c) in the entire cohort was poor (9.9%, 85 mmol/mol). A total of 15 SAEs were reported in 7 insulin-experienced patients (1 moderate event was related to BIAsp 30). Overall hypoglycaemia at Week 24 was 0.88 events/patient-year compared to 1.71 events/patient-year reported at baseline (change in proportion of patients affected, p < 0.0001). No major hypoglycaemia was reported at Week 24. BIAsp 30 significantly improved glucose control (HbA1c, fasting plasma glucose and postprandial plasma glucose, p < 0.001) at Week 24. The proportion of patients achieving HbA(1c) < 7.0% at Week 24 was 35.3% compared to 3.5% at baseline. The lipid profile and systolic blood pressure also improved significantly (p < 0.001). Quality of life was positively impacted (mean change in visual analogue scores from EQ-5D = 10.6 +/- 13.8 points, p < 0.001). Conclusion: BIAsp 30 was well-tolerated and improved glucose control while decreasing the risk of hypoglycaemia. (C) 2013 Elsevier Ireland Ltd. All rights reserved.