Abstract
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 human insulin regimens.Methods A1 chieve was a prospective,open-label,24-week observational study in patients with T2DM initiating insulin analogues therapy in routine clinical practice.In the present study,the data of patients who shifted previous treatment with human insulin to treatment with BIAsp 30 were summarized and analyzed.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 treatment regimen and dosing adjustment were decided at physician's discretion.Results A total of 1 588 Chinese patients with T2DM inadequately controlled on their previous human insulin regimens were treated with BIAsp 30 in this study,and 75.0％ of these patients were treated with premixed human insulin before the study.The incidences of total,nocturnal,and major hypoglyceamia (events · patient-1 · year-1) were 6.54,1.84,0.43 at baseline and 2.36,0.45,0 at week 24(all P＜0.01).HbA1cdecreased from (8.9 ± 2.3) ％ at baseline to (7.0 ± 1.1) ％ at week 24 (P＜0.05).The percentage of patients achieving HbA1C ＜7.0 ％ increased from 17.8％ at baseline to 54.8％ by week 24.Fasting plasma glucose and postprandial 2 h plasma glucose levels were decreased by (-2.3 ± 3.3) and (-3.8 ± 4.4) mmol/L,respectively (both P ＜0.05).Conclusions Treatment with BIAsp 30 in Chinese patients with T2DM,who were inadequately controlled on previous human insulin regimens,is associated with marked improvement in glycaemic control without evidence of clinically significant safety or tolerability problems. Key words: Biphasic insulin aspart 30; Human insulins; Diabetes mellitus, type 2; Insulin analogues; Hypoglycaemia
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