Pala L, Mannucci E, Dicembrini I, Rotella C M
Endocrine Unit, Department of Clinical Pathophysiology, University of Florence, Viale Pieraccini 6, 50139, Firenze, Italy.
Diabetes Res Clin Pract. 2007 Oct;78(1):132-5. doi: 10.1016/j.diabres.2007.02.010. Epub 2007 Apr 18.
This randomized, open-label, cross-over study compares the efficacy of mealtime rapid-acting analog insulin aspart with human insulin, in combination with metformin. A total of 30 patients with type 2 diabetes, inadequately controlled (HbA(1c)>7.5%) with oral hypoglycemic agents (OHAs), were assigned to human insulin 30 min before meals or aspart immediately before meals, both with metformin 500 mg t.i.d. for 90 days. Patients then switched to the alternate insulin. At 90 and 180 days, blood glucose and lipids were measured at baseline and every 30 min after test meals, for 3h. HbA(1c) and hypoglycemic events were also assessed. After 3 months, HbA(1c) was significantly reduced with aspart, but not human insulin (-0.4+/-0.7% versus +0.1+/-0.7%, p<0.05). During meal tests, blood glucose area under the curve (AUC) was significantly lower with aspart than human insulin (1240+/-476 min/mmol/l versus 1588+/-766 min/mmol/l, p<0.01). AUCs for lipids were similar for both treatments. Neither group experienced serious hypoglycemic events. These results encourage treatment with mealtime insulin aspart plus metformin, in type 2 diabetes patients with postprandial hyperglycemia inadequately controlled by OHAs alone.
这项随机、开放标签、交叉研究比较了餐时速效胰岛素类似物门冬胰岛素与人胰岛素联合二甲双胍的疗效。共有30例2型糖尿病患者，口服降糖药（OHAs）治疗血糖控制不佳（糖化血红蛋白>7.5%），被分配在餐前30分钟注射人胰岛素或在餐前即刻注射门冬胰岛素，均联合二甲双胍500mg每日三次，共90天。之后患者更换为另一种胰岛素。在90天和180天时，于基线及试餐后每30分钟测量血糖和血脂，共3小时。同时评估糖化血红蛋白和低血糖事件。3个月后，门冬胰岛素组糖化血红蛋白显著降低，而人胰岛素组未降低（-0.4±0.7% 对比 +0.1±0.7%，p<0.05）。餐时试验期间，门冬胰岛素组血糖曲线下面积（AUC）显著低于人胰岛素组（1240±476分钟/毫摩尔/升对比1588±766分钟/毫摩尔/升，p<0.01）。两种治疗的血脂AUC相似。两组均未发生严重低血糖事件。这些结果支持在仅用OHAs治疗餐后高血糖控制不佳的2型糖尿病患者时，采用餐时门冬胰岛素加二甲双胍治疗。
