EHM Clinic, Hoofddorp, The Netherlands.
Endocr Pract. 2011 Jan-Feb;17(1):41-50. doi: 10.4158/EP10079.OR.
To compare efficacy and safety of biphasic insulin aspart 70/30 (BIAsp 30) with insulin (glargine) in type 2 diabetic patients who were not maintaining glycemic control on basal insulin and oral antidiabetic drugs.
In a 24-week, open-label, parallel-group trial, type 2 diabetic patients who were not maintaining glycemic control on basal insulin (glargine or neutral protamine Hagedorn) + oral antidiabetic drugs were randomly assigned to twice-daily BIAsp 30 + metformin or once-daily glargine + metformin + secretagogues (secretagogues were discontinued in the BIAsp 30 arm).
One hundred thirty-seven patients were randomly assigned to the BIAsp 30 group and 143 patients were randomly assigned to the glargine group. Of 280 patients randomized, 229 (81.8%) completed the study. End-of-trial hemoglobin A1c reductions were -1.3% (BIAsp 30) vs -1.2% (glargine) (treatment difference: 95% confidence interval, -0.06 [-0.32 to 0.20]; P = .657). Of patients taking BIAsp 30, 27.3% reached a hemoglobin A1c level <7.0% compared with 22.0% of patients taking glargine (treatment difference: P = .388). Glucose increment averaged over 3 meals was lower in the BIAsp 30 arm (treatment difference: -17.8 mg/dL, P = .001). Fasting plasma glucose reductions from baseline were -13.8 mg/dL (BIAsp 30) vs -42.5 mg/dL (glargine) (P = .0002). Final minor hypoglycemia rate, insulin dose, and weight change were higher in the BIAsp 30 arm (6.5 vs 3.4 events/patient per year, P<.05; 1.19 vs 0.63 U/kg; and 3.1 vs 1.4 kg, P = .0004, respectively).
Despite not receiving secretagogues, patients taking BIAsp 30 + metformin achieved similar hemoglobin A1c levels and lower postprandial plasma glucose compared with those receiving glargine + metformin + secretagogues. The large improvement in the glargine group suggests the patients were not true basal failures at randomization. While switching to BIAsp 30 improves glycemic control in this patient population, remaining on basal insulin and optimizing the dose may be equally effective in the short term.
比较双相门冬胰岛素 70/30（BIAsp 30）与胰岛素（甘精胰岛素）在基础胰岛素和口服降糖药治疗血糖控制不佳的 2 型糖尿病患者中的疗效和安全性。
在一项为期 24 周、开放标签、平行分组的试验中，血糖控制不佳的基础胰岛素（甘精胰岛素或中性鱼精蛋白锌胰岛素）+口服降糖药的 2 型糖尿病患者被随机分为每日 2 次 BIAsp 30+二甲双胍或每日 1 次甘精胰岛素+二甲双胍+促泌剂（BIAsp 30 组停用促泌剂）。
137 例患者被随机分入 BIAsp 30 组，143 例患者被随机分入甘精胰岛素组。280 例随机患者中，229 例（81.8%）完成了研究。试验结束时血红蛋白 A1c 的降低幅度为-1.3%（BIAsp 30）与-1.2%（甘精胰岛素）（治疗差异：95%置信区间，-0.06[-0.32 至 0.20]；P=.657）。服用 BIAsp 30 的患者中，27.3%的患者达到了血红蛋白 A1c 水平＜7.0%，而服用甘精胰岛素的患者中为 22.0%（治疗差异：P=.388）。BIAsp 30 组 3 餐时的平均血糖升高幅度较低（治疗差异：-17.8mg/dL，P=.001）。从基线开始的空腹血糖降低幅度为-13.8mg/dL（BIAsp 30）与-42.5mg/dL（甘精胰岛素）（P=.0002）。BIAsp 30 组的低血糖发生率（6.5 次/患者/年比 3.4 次/患者/年，P＜0.05）、胰岛素剂量（1.19U/kg 比 0.63U/kg）和体重变化（3.1kg 比 1.4kg）更高（P=.0004）。
尽管未使用促泌剂，服用 BIAsp 30+二甲双胍的患者与服用甘精胰岛素+二甲双胍+促泌剂的患者相比，血红蛋白 A1c 水平相似，餐后血糖更低。甘精胰岛素组的显著改善提示这些患者在随机分组时并非真正的基础胰岛素失败。虽然改用 BIAsp 30 改善了血糖控制，但在短期内继续使用基础胰岛素并优化剂量可能同样有效。
