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 OADs

Abstract

Objective: To assess efficacy and safety of twice- (BID) and three-times daily (TID) biphasic insulin aspart 30 (BIAsp 30) in Chinese subjects with type 2 diabetes inadequately controlled with oral antidiabetic 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 [FBG] ≥7.8 mmol/l; HbA_1c ≥7.5%) were randomized (1:1) to BID or TID BIAsp 30 without OADs. Initial insulin doses were based on FBG at randomization. Insulin dose was adjusted with algorithm-controlled titration to achieve pre-meal BG of 4.4–6.1 mmol/L.

Results: HbA_1c decreased significantly in both groups (BID: –2.48±0.07%; TID: –2.81±0.07%). TID BIAsp 30 showed superiority in HbA_1c improvement (–0.33%, 95% CI (–0.53; –0.13), P<0.01) and helped more subjects achieve HbA_1c targets <7% (BID: 51.3% vs. TID: 65.8%, P<0.01). TID BIAsp 30 was more effective in subjects with HbA_1c baseline ≥ 9% (<7%: BID: 41.5% vs. TID: 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: 3.87±0.28 kg; TID: 4.09±0.27 kg) and mean daily insulin doses (BID: 0.82±0.28 U/kg; TID: 0.86±0.34 U/kg) were observed.

Conclusions: BID and TID BIAsp 30 were effective in Chinese insulin-naïve subjects with poorly controlled type 2 diabetes. TID BIAsp 30 offered greater reduction in HbA_1c without increasing risk of hypoglycemia, insulin dose and weight gain, especially in subjects with HbA_1c ≥ 9%.