Biphasic insulin aspart 30 as insulin initiation or replacement therapy: the China cohort of the IMPROVE study.

Aims: To explore safety and efficacy of BIAsp 30 as initiation or replacement therapy in routine clinical practice in patients with poorly controlled diabetes in the Chinese cohort of the IMPROVE study. Methods: In the 26-week, non-interventional, observational study, Chinese subjects with diabetes started BIAsp 30 treatment in routine care. Data from patients' diaries and medical records were transferred to CRFs by participating physicians. Clinical trial registration: NCT00659282. Results: Of the 21,729 subjects enrolled (mean age 54.0 years, BMI 24.6 kg/m(2), diabetes duration 4.86 years), 32.3% were treatment-naive, 59.3% were from oral anti-diabetic drugs (OADs) only and 8.1% were from insulin +/- OADs. Overall, mean HbA(1c) and FBG decreased by 2.82% and 5 mmol/L, respectively. In the subgroups, changes were: -3.27% and -6.06 mmol/L (treatment-naive), -2.57% and -4.54 mmol/L (OADs only), -2.96% and 3.51 mmol/L (insulin +/- OADs) all p < 0.05. HbA(1c)< 7% was achieved by 71.4% of patients. Only 0.1% of subjects reported major hypoglycaemia and 73 SADRs were observed without significant difference compared to those at baseline. Body weight did not change significantly. Conclusions: Regardless of previous treatments, insulin initiation or replacement with BIAsp 30 improved glycaemic control without increasing major hypoglycaemia or weight gain in Chinese patients with diabetes.