Safety and efficacy of biphasic insulin aspart 30 in type 2 diabetes patients switched from either biphasic or basal human insulin: results from the Gulf cohort of the A1chieve study

Aim: The 24-week, international, non-interventional A(1)chieve study aimed to evaluate the safety and efficacy of insulin analogues in type 2 diabetes (T2D) in different countries. This sub-analysis reports results for T2D patients who switched from either biphasic human insulin (BHI) or human neutral protamine Hagedorn (NPH) insulin to biphasic insulin aspart 30 (BIAsp 30) in the Gulf cohort. Methods: Gulf patients with T2D who switched to BIAsp 30 from either BHI or NPH insulin were included. Safety and efficacy measurements were made by the physicians as part of routine clinical care. Results: A total of 1486 patients switched from BHI to BIAsp 30 (BIP group) and 232 patients switched from NPH insulin to BIAsp 30 (NEU group). Baseline glycated haemoglobin A(1c) (HbA(1c)) was poor in patients in the BIP and NEU groups (mean value +/- SD: 9.4 +/- 1.8% and 9.7 +/- 1.5%, respectively). Significant reductions in the proportion of patients reporting hypoglycaemia (overall, major, minor and nocturnal) were noted in the BIP group after 24 weeks of BIAsp 30 therapy (p < 0.001). No major hypoglycaemic events were reported at Week 24 in the NEU group. In both groups, the mean HbA1c, fasting plasma glucose and postprandial plasma glucose improved significantly after 24 weeks of BIAsp 30 therapy (p < 0.001). The mean body weight, lipid parameters and systolic blood pressure also improved significantly in both groups (p < 0.05). Conclusion: BIAsp 30 therapy enhanced glycaemic control over 24 weeks and was well-tolerated in T2D patients poorly controlled on prestudy BHI or NPH insulin.