Switching from biphasic human insulin to biphasic insulin aspart 30 in type 2 diabetes: Results from the ASEAN subgroup of the A1chieve study
Diabetes Research and Clinical Practice, pages S24 - S29
Published online Aug-2013
To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in ASEAN type 2 diabetes (T2D) patients switched from biphasic human insulin (BHI) in the non-interventional 24-week A1chieve study.
Indonesian, Malaysian, Filipino and Singaporean patients switched from BHI to BIAsp 30 at their physicians’ discretion were included. The incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia was the primary endpoint. Changes in hypoglycaemia, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), lipids, body weight and systolic blood pressure were also evaluated. Quality of life (QoL) was measured using the EQ-5D questionnaire.
For the 465 patients included (mean±SD age: 56±10.3 years, diabetes duration: 9.7±7.1 years, baseline HbA1c: 9.4±1.8%), the mean pre-study BHI dose was 0.62±0.28 IU/kg and 63.4% were dosing BHI twice daily (bid). The mean baseline BIAsp 30 dose was 0.65±0.27U/kg, titrated up to 0.71±0.28U/kg over 24 weeks, and most patients continued bid dosing. No SADRs or major hypoglycaemic episodes were reported. The proportion of patients reporting overall hypoglycaemia decreased significantly from 10.8% at baseline to 3.4% at Week 24 (p < 0.0001). Significant improvements in glycaemic control were noted (HbA1c: –1.4±1.7%, FPG: –56.7±72.5 mg/dL, post-breakfast PPPG: –84.8±82.8 mg/dL, p < 0.001). Mean QoL improved by +6.6±14.6 points (p < 0.001).
BIAsp 30 was well-tolerated and significantly increased glycaemic control in this ASEAN subgroup poorly controlled on BHI.
Keywords: Biphasic insulin aspart, Biphasic human insulin, ASEAN, Type 2 diabetes.
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a Hospital Putrajaya, Putrajaya, Malaysia Hospital Putrajaya, Putrajaya, 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 Department of Endocrinology, Singapore General Hospital, Singapore Department of Endocrinology, Singapore General Hospital, Singapore
e Sp-PD-KEMO, University of Indonesia, Jakarta, Indonesia Sp-PD-KEMO, University of Indonesia, Jakarta, Indonesia
Corresponding author at: Department of Medicine, Hospital Putrajaya, Presint 7, 62250 Putrajaya, W.P. Putrajaya, Malaysia. Tel.: +6012 290 7136
© 2013 Published by Elsevier B.V.