Safety, Tolerability, and Efficacy of Insulin Aspart in People with Type 2 Diabetes, as Biphasic Insulin Aspart or with Basal Insulin: Findings from the Multinational, Non-Interventional A1chieve Study

INTRODUCTION The aim of the study was to investigate the clinical safety and effectiveness of starting insulin aspart (aspart) therapy in people with type 2 diabetes mellitus (T2DM) as a sub-analysis of the multinational, non-interventional A1chieve study. METHODS Insulin-naïve and insulin-experienced people with T2DM in routine clinical care starting aspart alone at baseline and continuing aspart alone, changing to biphasic insulin aspart 30 (aspart premix) or adding a basal insulin by study end, were included. Safety, tolerability, and efficacy were evaluated over 24 weeks. RESULTS Overall, 3,898 people started aspart at baseline. Of the 3,313 with 24-week data, 1,545 (46.6%) continued with aspart, 1,379 (41.6%) switched to aspart premix, and 214 (6.5%) added basal insulin, while the remainder switched to other regimens. No serious adverse drug reactions were reported. The proportion of participants reporting hypoglycemia decreased from baseline to week 24 in the aspart alone group (11.2% versus 4.1%, p < 0.001) and in the aspart + basal insulin group (13.1% versus 7.5%, p = 0.040), and was 3.7% at week 24 in the aspart premix group. The mean HbA1c decreased from baseline to week 24 (aspart: -2.1 ± 2.0% [-23 ± 22 mmol/mol], aspart premix: -2.3 ± 1.7% [-25 ± 19 mmol/mol], aspart + basal insulin: -2.0 ± 2.1% [-22 ± 23 mmol/mol]; p < 0.001). CONCLUSION Insulin aspart therapy was well tolerated and was associated with improved glucose control over 24 weeks in people with T2DM.