Pradana Soewondo and Dharma Lindarto and Sony Wibisono and Olly Renaldi and Tjokorda Gde Dalem-Pemayua (2013) 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, 100 (Supp1). pp. 41-46. ISSN 0168-8227

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Abstract

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 A1chieve 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±3.8kg/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). 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.

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