Department of Internal Diseases Diabetology and Nephrology, Silesian Medical University, Zabrze, Poland.
Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674.
To assess the efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) and insulin glargine, administered once daily in subjects with type 2 diabetes inadequately controlled with oral anti-diabetic drugs.
In this 26-week, open-labeled, randomized, parallel-group, multinational, treat-to-target trial, 480 insulin-naïve subjects were randomized to receive either BIAsp 30 before dinner or insulin glargine at bedtime, both in combination with metformin and glimepiride.
NCT00469092, ClinicalTrials.gov.
A total of 433 subjects completed the trial. Estimated mean reduction in HbA(1c) from baseline to end of treatment was -1.41% with BIAsp 30 and -1.25% with insulin glargine (BIAsp 30 - insulin glargine = -0.16%, 95% CI [-0.30; -0.02], p = 0.029). At the end of treatment, mean HbA(1c) was 7.1% and 7.3% for BIAsp 30 and insulin glargine, respectively. Significantly lower plasma glucose levels were observed with BIAsp 30 post-dinner (BIAsp 30 - insulin glargine = -0.52 mmol/L, 95% CI [-1.02; -0.03], p = 0.04) and at bedtime (BIAsp 30 - insulin glargine = -0.78 mmol/L, 95% CI [-1.25; -0.31], p < 0.01). The relative risk (RR) of experiencing a nocturnal hypoglycemic episode (00:00-06.00 a.m.) was significantly higher with BIAsp 30 than with insulin glargine (1.1 versus 0.5 episodes/year, RR = 2.41, 95% CI [1.34; 4.34], p = 0.003), but overall hypoglycemia rates were low. There were three major hypoglycemic episodes in each group.
With respect to HbA(1c), BIAsp 30 fulfilled the statistical criteria for non-inferiority and superiority to insulin glargine and, according to pre-defined criteria, the improvements in HbA(1c) are considered clinically equivalent. Subjects had an increased risk of minor nocturnal hypoglycemia with BIAsp 30. There were no differences in treatment satisfaction between the two groups.
评估在口服降糖药物治疗效果不佳的 2 型糖尿病患者中，每日一次给予双相门冬胰岛素 70/30（BIAsp 30）和甘精胰岛素的疗效和安全性。
这是一项为期 26 周、开放性、随机、平行分组、多国、以目标为导向的试验，共纳入 480 例胰岛素初治的受试者，随机分为两组，分别于晚餐前接受 BIAsp 30 治疗，或于睡前接受甘精胰岛素治疗，两组均联合使用二甲双胍和格列美脲。
NCT00469092，ClinicalTrials.gov。
共有 433 例受试者完成了试验。BIAsp 30 组和甘精胰岛素组治疗结束时 HbA1c 较基线的平均降幅分别为-1.41%和-1.25%（BIAsp 30 组-甘精胰岛素组差值为-0.16%，95%CI[-0.30; -0.02]，p=0.029）。治疗结束时，BIAsp 30 组和甘精胰岛素组的平均 HbA1c 分别为 7.1%和 7.3%。BIAsp 30 组晚餐后（BIAsp 30 组-甘精胰岛素组差值为-0.52mmol/L，95%CI[-1.02; -0.03]，p=0.04）和睡前（BIAsp 30 组-甘精胰岛素组差值为-0.78mmol/L，95%CI[-1.25; -0.31]，p<0.01）的血糖水平明显更低。BIAsp 30 组夜间（00:00-06:00 时）发生低血糖事件的风险相对较高（1.1 次/年 vs. 0.5 次/年，RR=2.41，95%CI[1.34; 4.34]，p=0.003），但总体低血糖发生率较低。两组各发生 3 例严重低血糖事件。
在 HbA1c 方面，BIAsp 30 达到了非劣效性和优于甘精胰岛素的统计学标准，根据预先设定的标准，HbA1c 的改善被认为具有临床等效性。与甘精胰岛素相比，BIAsp 30 组患者发生轻微夜间低血糖的风险增加。两组患者的治疗满意度无差异。
