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ORIGINAL ARTICLE
Year : 2015  |  Volume : 19  |  Issue : 1  |  Page : 110-115

Clinical experience of switching from biphasic human insulin to biphasic insulin aspart 30 in Indian patients with type 2 diabetes in the A 1 chieve study


1 Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
2 Department of Endocrinology, Bharti Hospital and B.R.I.D.E, Karnal, Haryana, India
3 Novo Nordisk India Private Limited, Bengaluru, Karnataka, India
4 Diabetes Care and Research Centre, Patna, Bihar, India

Correspondence Address:
Shahid Akhtar
Novo Nordisk India Private Limited, Plot No. 32, 47-50, EPIP Area, Whitefield, Bengaluru - 560 066, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.131759

Clinical trial registration NCT00869908

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Aim: The aim of the following study is to evaluate the safety and effectiveness of switching from biphasic human insulin (BHI) to biphasic insulin aspart 30 (BIAsp 30) in Indian patients with type 2 diabetes as a sub-analysis of the 24-week, non-interventional A 1 chieve study. Materials and Methods: Indian patients switching from BHI to BIAsp 30 based on the physicians' decisions were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycemic events; secondary outcomes included changes in hypoglycemia in the 4 weeks preceding baseline and week 24 and changes from baseline to week 24 in glycated hemoglobin A 1c (HbA 1c ), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), body weight and quality of life (QoL). Results: Overall, 1976 patients (mean ± standard deviation age, 55.1 ± 10.6 years and diabetes duration, 10.1 ± 5.3 years) on a mean pre-study BHI dose of 0.44 ± 0.18 U/kg were included. The mean BIAsp 30 dose was 0.43 ± 0.17 U/kg at baseline and 0.44 ± 0.17 U/kg at week 24. No SADRs were reported. The proportion of patients reporting overall hypoglycemic events reduced significantly from baseline to week 24 (15.0% vs. 2.9%, P < 0.0001). The mean HbA 1c level improved significantly from 9.1 ± 1.4% at baseline to 7.5 ± 1.0% at week 24, along with improvements in FPG, post-breakfast PPPG and QoL (P < 0.001). The mean body weight decreased from 69.3 ± 10.8 kg at baseline to 69.1 ± 10.4 kg at week 24 (P = 0.003). Conclusion: Switching from BHI to BIAsp 30 therapy was well-tolerated and was associated with improved glycemic control.


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