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

Abstract

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-target study, 321 Chinese insulin-naïve subjects with poorly controlled type 2 diabetes (fasting blood glucose ≥7.8 mmol/l and A1C ≥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—A1C decreased significantly in both groups (BID group −2.48 ± 0.07%; TID group −2.81 ± 0.07%). Thrice-daily BIAsp 30 showed superiority in A1C improvement (−0.33% [95% CI −0.53 to −0.13]; P < 0.01) and helped more subjects achieve A1C 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 A1C ≥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-naïve subjects with poorly controlled type 2 diabetes. Thrice-daily BIAsp 30 offered greater reduction in A1C without increasing risk of hypoglycemia, insulin dose, and weight gain, especially in subjects with A1C ≥9%.