Biphasic insulin aspart 30 three times daily is more effective than a twice-daily regimen, without increasing hypoglycemia, in Chinese subjects with type 2 diabetes inadequately controlled on oral antidiabetes drugs

OBJECTIVE - To assess the efficacy and safety of twice- and thrice-daily biphasic insulin aspart 30 (BIAsp 30) in Chinese subjects with type 2 diabetes inadequately controlled with oral antidiabetes drugs (OADs). RESEARCH DESIGN AND METHODS - In this 24-week, multicenter, parallel-group, randomized, treat-to-targeL Study, 321 Chinese insulin-naive subjects with poorly controlled type 2 diabetes (fasting blood glucose >= 7.8 mmol/l and AlC >= 7.5 %) were randomized (1:1) to twice- or thrice-daily (BID and TID groups, respectively) BIAsp 30 without OADs. Initial insulin doses were based on fasting blood glucose at randomization. Insulin dose was adjusted with algorithm-controlled titration to achieve premeal blood glucose of 4.4-6.1 mmol/l. RESULTS - AlC decreased significantly in both groups (BID group -2.48 +/- 0.07%; TID group -2.81 +/- 0.07%). Thrice-daily BIAsp 30 showed superiority in AlC improvement (-0.33% 195% CI -0.53 to -0.131; P < 0.01) and helped more subjects achieve AlC targets < 7% (BID group 51.3% vs. TID group 65.8%; P < 0.01). Thrice-daily BIAsp 30 was more effective in subjects with baseline AlC >= 9% (< 7%: BID group 41.5% vs. TID group 58.3%; P < 0.01), There was no significant difference in rates of overall and nocturnal major and minor hypoglycemia per subject year between groups. No significant differences in weight gain (BID group 3.87 +/- 0.28 kg; TID group 4.09 +/- 0.27 kg) and mean daily insulin doses (BID group 0.82 +/- 0.28 units/kg; TID group 0.86 +/- 0.34 units/kg) were observed. CONCLUSIONS - Twice-and thrice-daily BIAsp 30 were effective in Chinese insulin-naive subjects with poorly controlled type 2 diabetes. Thrice-daily BIAsp 30 offered greater reduction in AlC without increasing risk of hypoglycemia, insulin dose, and weight gain, especially in subjects with AlC >= 9%.