Safety and effectiveness of biphasic insulin aspart 30 in Chinese patients with type 2 diabetes: results from the A1chieve study

Objective To evaluate clinical safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Chinese patients with type 2 diabetes mellitus(T2DM) inadequately controlled on their previous treatments. Methods A1chieve study was a prospective, open-label, 24-week observational study in patients with type 2 diabetes initiating insulin analogues therapy in routine clinical practice. From November 2008 to March 2011, eligible patients who had decided to start BIAsp 30 based on physicians' clinical judgments were enrolled into this study from 130 hospitals in China. The overall study population contains 8578 Chinese patients with T2DM who were treated with BIAsp 30. Among the overall study population, a subgroup of 1191 patients was treated with biphasic human insulin before study. The treatment regimen and dosing adjustment were decided at physician's discretion. Results The rates of total, major, and nocturnal hypoglyceamia (events/patient/year) of the overall study population were 2.32, 0.15, 0.58 at baseline and 1.54, 0.00, 0.28 at week 24 for the overall population (Fisher exact test P<0.05, P<0.01, P<0.01). Glycaemic control was poor at baseline reflected by HbA1c (9.5±2.3) %. After 24 weeks treatment, HbA1c of the overall study population decreased to (7.0±1.0) % (P<0.01). Fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) were both improved for the overall population (changes were (-3.5±3.6) mmol/L and (-5.5±5.0) mmol/L, with both P value <0.01). The rates of total, major, and nocturnal hypoglyceamia (events/patient/year) were 7.20, 0.51, 2.15 at baseline and 2.37, 0.00, 0.43 at week 24 for subgroup patients (all P value <0.01). The HbA1c of these patients decreased from (8.7±2.1) % at baseline to (7.0±1.1) % at week 24 (P<0.01). Conclusion Beginning BIAsp 30 therapy in Chinese patients with T2DM inadequately controlled on previous treatment is associated with marked improvements in glycaemic control, without evidence of clinically significant safety or tolerability concerns, regardless of the previous treatment regimen. Key words: Biphasic insulin aspart 30; Diabetes mellitus, type 2; Hypoglycaemia; Insulin analogues