JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

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

Wenying Yang, Qiuhe Ji, Dalong Zhu, Jinkui Yang, Lulu Chen, Zhimin Liu, Demin Yu, Li Yan
Diabetes Care 2008, 31 (5): 852-6
18268073

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 >or=7.8 mmol/l and A1C >or=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 >or=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 >or=9%.

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