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 Research and Clinical Practice, pages S41 - S46
Published online Aug-2013
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.
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.
A total of 244 patients with mean age ± SD 55.6±9.5 years, BMI 24.6±3.8kg/m2, 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±0.26U/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).
Switching from BHI 30 to BIAsp 30 in this Indonesian cohort was well-tolerated and improved glycaemic control with a decreased risk of hypoglycaemia.
Keywords: Switch, Biphasic human insulin 30, Biphasic insulin aspart 30, Indonesia.
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a University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia
b Division of Endocrine Metabolic, Department of Internal Medicine, H Adam Malik Hospital, Medan, Indonesia Division of Endocrine Metabolic, Department of Internal Medicine, H Adam Malik Hospital, Medan, Indonesia
c Diabetes and Nutrition Centre, Dr. Soetomo Hospital, School of Medicine Airlangga University, Surabaya, Indonesia Diabetes and Nutrition Centre, Dr. Soetomo Hospital, School of Medicine Airlangga University, Surabaya, Indonesia
d Mitra Bekasi Barat Hospital, Bekasi, Indonesia Mitra Bekasi Barat Hospital, Bekasi, Indonesia
e Diponegoro University, Kariadi Hospital, Semarang, Indonesia Diponegoro University, Kariadi Hospital, Semarang, Indonesia
Corresponding author at: Sp-PD-KEMO, Division of Endorinology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia, Cipto Mangunkusomo Hospital, Jakarta, Indonesia. Tel.: +62 21 390 7703; fax: +62 21 392 8659
© 2013 Published by Elsevier B.V.