Anderson J H, Brunelle R L, Keohane P, Koivisto V A, Trautmann M E, Vignati L, DiMarchi R
Lilly Research Laboratories, Indianapolis, Ind., USA.
Arch Intern Med. 1997 Jun 9;157(11):1249-55.
Insulin lispro is an insulin analog that was recently developed particularly for a mealtime therapy. It has a fast absorption rate and short duration of action. The efficacy of insulin lispro in the clinical therapy of patients with non-insulin-dependent diabetes mellitus (NIDDM) has not been tested.
To compare insulin lispro and human regular insulin in the mealtime treatment of patients with NIDDM.
A 6-month, randomized, multinational (16 countries), multicenter (80 sites) clinical trial with an open-label, crossover design was performed in 722 patients with NIDDM. Insulin lispro was injected immediately before and human regular insulin 30 to 45 minutes before the meal.
Throughout the study, the postprandial rise in serum glucose levels was significantly lower during insulin lispro than human regular insulin treatment. At end point the rise (mean +/- SEM) in serum glucose levels was 30% lower at 1 hour (2.6 +/- 0.1 mmol/L [46.8 +/- 1.8 mg/ dL] for lispro vs 3.7 +/- 0.1 mmol/L [66.6 +/- 1.8 mg/dL] for human regular insulin) and 53% lower 2 hours after the test meal (1.4 +/- 0.1 mmol/L [25.2 +/- 1.8 mg/dL] for lispro vs 3.0 +/- 0.1 mmol/L [54.0 +/- 1.8 mg/dL] for human regular insulin) with insulin lispro compared with human regular insulin therapy (P < .001 for both intervals). During insulin lispro therapy the rate of hypoglycemia overall (P = .01) and overnight (P < .001) was lower and the number of asymptomatic hypoglycemic episodes was smaller (P = .03) than during human regular insulin therapy. Associated with a similar 13% increase (P < .001) in the total daily insulin dose, the glycosylated hemoglobin level decreased (P < .001) equally in both treatment groups. Serum lipid and lipoprotein levels remained unchanged. There were no differences in the adverse events between the 2 treatment groups.
Compared with human regular insulin therapy, mealtime therapy with insulin lispro reduced postprandial hyperglycemia and may decrease the rate of mild hypoglycemic episodes in patients with NIDDM.
赖脯胰岛素是一种最近专门为餐时治疗开发的胰岛素类似物。它具有快速的吸收率和较短的作用持续时间。赖脯胰岛素在非胰岛素依赖型糖尿病（NIDDM）患者临床治疗中的疗效尚未得到检验。
比较赖脯胰岛素和人常规胰岛素在NIDDM患者餐时治疗中的效果。
对722例NIDDM患者进行了一项为期6个月、随机、多国（16个国家）、多中心（80个地点）的开放标签交叉设计临床试验。赖脯胰岛素在进餐前即刻注射，人常规胰岛素在进餐前30至45分钟注射。
在整个研究过程中，赖脯胰岛素治疗期间餐后血清葡萄糖水平的升高显著低于人常规胰岛素治疗。在研究终点，赖脯胰岛素治疗组1小时时血清葡萄糖水平的升高（平均值±标准误）比人常规胰岛素治疗组低30%（赖脯胰岛素组为2.6±0.1 mmol/L [46.8±1.8 mg/dL]，人常规胰岛素组为3.7±0.1 mmol/L [66.6±1.8 mg/dL]），试验餐后2小时低53%（赖脯胰岛素组为1.4±0.1 mmol/L [25.2±1.8 mg/dL]，人常规胰岛素组为3.0±0.1 mmol/L [54.0±1.8 mg/dL]），与常规胰岛素治疗相比，差异均有统计学意义（两个时间段P均<0.001）。与常规胰岛素治疗相比接受赖脯胰岛素治疗时，总体低血糖发生率（P = 0.01）和夜间低血糖发生率（P < 0.001）更低，无症状低血糖发作次数更少（P = 0.03）。在每日胰岛素总剂量增加相似的13%（P < 0.001）的情况下，两个治疗组糖化血红蛋白水平均有同等程度的下降（P < 0.001）。血清脂质和脂蛋白水平保持不变。两个治疗组的不良事件无差异。
与常规人胰岛素治疗相比，赖脯胰岛素餐时治疗可降低NIDDM患者餐后高血糖，并可能降低轻度低血糖发作的发生率。
