Safety and effectiveness of insulin aspart in type 2 diabetic patients: Results from the ASEAN cohort of the A1chieve study
Diabetes Research and Clinical Practice, pages S17 - S23
Published online Aug-2013
To examine the clinical safety and effectiveness of insulin aspart (IAsp) therapy in type 2 diabetes (T2D) patients from the ASEAN cohort of the international, 24-week, non-interventional A1chieve study.
T2D patients from Indonesia, Malaysia, Philippines and Singapore, who started IAsp therapy with or without oral glucose-lowering drugs, were included. The primary endpoint was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events. Secondary endpoints included hypoglycaemia, glycated haemoglobin A1c [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPPG], systolic blood pressure [SBP], body weight and lipids. Quality of life (QoL) was assessed using the EQ-5D questionnaire. Results: Overall, 312 T2D patients (222 insulin-naive and 90 insulin-experienced) with a mean±SD age of 56.6±11.2 years, BMI of 24.2±3.9 kg/m2 and diabetes duration of 7.0±5.7 years were included. The mean daily IAsp dose was 0.51±0.31U/kg at baseline titrated up to 0.60±0.29U/kg at Week 24. No SADRs or major hypoglycaemic events were reported in the entire subgroup. The proportion of patients who reported overall hypoglycaemia decreased from baseline to Week 24 (7.1% vs. 0.3%, p < 0.0001). The mean HbA1c improved from 9.5±1.6% at baseline to 7.6±1.3% after 24 weeks (p < 0.001). The mean FPG, post-breakfast PPPG and SBP also improved (p < 0.001). Health-related QoL scores increased in the entire subgroup (mean increase: 9.8±14.6 points, p < 0.001).
Starting IAsp therapy was well-tolerated and was associated with significantly improved overall glycaemic control in the ASEAN cohort.
Keywords: Type 2 diabetes, Insulin aspart, ASEAN, A1chieve, Non-interventional study.
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a Universiti Sains Malaysia, 16150 Kubang Kerian, Kota Bharu, Kelantan, Malaysia Universiti Sains Malaysia, 16150 Kubang Kerian, Kota Bharu, Kelantan, Malaysia
b University of the Philippines College of Medicine, Manila, Philippines University of the Philippines College of Medicine, Manila, Philippines
c Novo Nordisk Pharma Malaysia Sdn Bhd, Kuala Lumpur, Malaysia Novo Nordisk Pharma Malaysia Sdn Bhd, Kuala Lumpur, Malaysia
d National Healthcare Group Polyclinics, Singapore National Healthcare Group Polyclinics, Singapore
e University of Indonesia, Jakarta, Indonesia University of Indonesia, Jakarta, Indonesia
Corresponding author at: Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kota Bharu, Kelantan, Malaysia. Tel.: +6013 938 6005
© 2013 Published by Elsevier B.V.