Biphasic insulin aspart 30 in insulin-naive people with Type 2 diabetes in non-western nations: Results from a regional comparative multinational observational study (A1chieve)

Background: A(1)chieve((R)) (Novo Nordisk A/S, Bagsvaerd, Denmark) was a prospective, multicenter, noninterventional study in 66,726 people with type 2 diabetes mellitus (T2DM) in 28 countries beginning biphasic insulin aspart 30 (aspart premix), insulin detemir, or insulin aspart in routine clinical care. Subjects and Methods: A subgroup of 27,594 insulin-naive people began therapy with aspart premix with or without oral agents. Safety and effectiveness data were taken from clinic records at baseline and after 24 weeks. Seven regional country groupings were prespecified. Results: Mean final insulin dose ranged from 0.680.26U/kg/day (Middle East/Gulf) to 0.38 +/- 0.14U/kg/day (South Asia). The baseline glycated hemoglobin (HbA(1c)) level varied from 10.5 +/- 2.0% (Latin America) to 9.2 +/- 1.3% (South Asia), with reductions from -2.9 +/- 2.1% (Latin America) to -1.9 +/- 1.3% (South Asia). The proportion of people reaching an HbA(1c) level of <7.0% was highest in China (56%) and lowest in North Africa (22%). Fasting plasma glucose level reductions were from -6.4 +/- 5.3mmol/L (Latin America) to -3.6 +/- 2.6mmol/L (South Asia). Most people began aspart premix twice daily, varying from 91% (North Africa) to 70% (Latin America). Improvement in HbA(1c) increased with baseline dose frequency (once daily, -1.5 +/- 1.4%; twice daily, -2.2 +/- 1.6%; three times daily, -2.9 +/- 2.2%). Conclusions: Insulin-naive people with T2DM beginning aspart premix insulin in routine clinical practice in non-western nations had clinically useful improvements in blood glucose control after 24 weeks in all seven regions. Improvements from baseline for glucose control variables were greater than cross-regional differences in those variables at 24 weeks.