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

Objective To evaluate the efficacy and safety of biphasic insulin aspart 30 (BIAsp30), and quality of life in Chinese elderly patients (> 65 years-old) with type 2 diabetes in regular clinical practice, and to compare with the data from Chinese young patients (≤65 years-old). Methods A1chieve study is a 24 weeks, prospective, multi-center, open-label, non-interventional research. Patients were grouped by age, and further grouped into insulin-naive and insulin-experienced, respectively. Results A total of 1 969 elderly patients and 6 508 young, who were treated with BIAsp30 during the A1chieve research in China, were analyzed. No serious adverse drug reaction was reported. The rate of total, nocturnal, and major hypoglycemic events were 2.84/0.91/0.34 event/patient-year, reported by elderly patients with diabetes at baseline, and were decreased to 2.00/0.41 (P=0.0371)/0 event/patient-year, respectively, after 24 weeks treatment with BIAsp30. The corresponding rates reported by young patients were reduced from 2.19/0.48/0.10 event/patient-year at baseline to 1.39/0.23 (P<0.001)/0 event/patient-year at 24 weeks, respectively. HbA1c decreased from (9.3±2.3)% and (9.6±2.3)% at baseline to (7.0±1.0)% and (7.0±1.0)% at end of study in elderly and young patients, respectively (elderly t=-33.47, P<0.001; young t=-67.94, P<0.001). The proportion of elderly and young patients who achieved HbA1c < 7% increased from 13.8% (223/1 620) and 9.5% (514/5 390) at baseline to 57.7% (682/1 182) and 55.0% (2 124/3 863) at end of the study. Fasting plasma glucose decreased from (9.8±3.5) and (10.4±3.6) mmol/L at baseline to (6.8±1.2) and (6.7±1.3) mmol/L at end of study (elderly t=-32.86, P<0.001; young t=-70.02, P<0.001); postprandial plasma glucose (after breakfast) reduced from (13.9±4.8) and (14.4±4.9) mmol/L at baseline to (8.9±1.7) and (8.8±1.8) mmol/L at end of study (elderly t=-34.14, P<0.001; young t=-67.70, P<0.001), in elderly and young patients, respectively. The quality of life were significantly ameliorated in both elderly and young patients. Conclusions BIAsp30 improved glycemic control effectively, without increasing the risk of hypoglycemia, and particularly reduced the risk of nocturnal and major hypoglycemia. The application of BIAsp30 is similarly effective and safe in both Chinese elderly and young patients with type 2 diabetes. Key words: Diabetes, type 2; Elderly diabetes; Insulin analogues; Biphasic insulin aspart 30