Nelson Patric, Poon Terri, Guan Xuesong, Schnabel Catherine, Wintle Matthew, Fineman Mark
Amylin Pharmaceuticals Inc., San Diego, California, USA.
Diabetes Technol Ther. 2007 Aug;9(4):317-26. doi: 10.1089/dia.2006.0024.
Exenatide is an adjunctive therapy for type 2 diabetes, and preliminary evidence suggests that its glucoregulatory effects may be similar in the absence of oral therapy.
Study A was a randomized, double-blind, placebo-controlled study of 99 patients with type 2 diabetes that received either 10 microg twice-daily, 10 microg once-daily, or 20 microg once-daily exenatide or placebo for 28 days in the absence of background pharmacotherapy. Study B was an open-label extension of a short-term study of 127 patients with type 2 diabetes treated with metformin or diet and exercise. Patients received exenatide 5 microg twice-daily for 4 weeks followed by 10 microg for 26 weeks. Subjects treated with metformin continued oral therapy.
Monotherapeutic treatment with 10 microg of exenatide twice-daily for 28 days resulted in significant mean reductions in glycosylated hemoglobin (A1C) of -0.4 +/- 0.1% and fasting plasma glucose of -36.1 +/- 11.0 mg/dL compared to increases of +0.2 +/- 0.1% and +11.0 +/- 12.7 mg/dL with placebo. Self-monitored blood glucose profiles showed significant mean reductions in daily blood glucose concentrations in exenatide-treated patients compared to placebo. Exenatide treatment for 30 weeks in an open-label extension study resulted in similar mean reductions from baseline in A1C and body weight in patients treated with diet and exercise alone (-1.0 +/- 0.2% and -4.3 +/- 1.3 kg, respectively) as those treated on a background of metformin (-0.9 +/- 0.1% and -3.7 +/- 0.5 kg, respectively). In both studies, the most frequent adverse events were gastrointestinal and predominantly mild to moderate in intensity. Incidence of mild-to-moderate hypoglycemia was low, with no severe hypoglycemia.
Exenatide twice-daily monotherapy resulted in glycemic improvements and reductions in body weight comparable to that of exenatide combination therapy with metformin in patients with type 2 diabetes.
艾塞那肽是2型糖尿病的辅助治疗药物，初步证据表明，在未进行口服治疗的情况下，其血糖调节作用可能相似。
研究A是一项随机、双盲、安慰剂对照研究，99例2型糖尿病患者在无背景药物治疗的情况下，接受每日两次10微克、每日一次10微克、每日一次20微克的艾塞那肽或安慰剂治疗28天。研究B是一项对127例接受二甲双胍治疗或饮食及运动治疗的2型糖尿病患者进行的短期研究的开放标签扩展研究。患者先接受每日两次5微克的艾塞那肽治疗4周，随后接受10微克治疗26周。接受二甲双胍治疗的受试者继续口服治疗。
与安慰剂组糖化血红蛋白（A1C）升高0.2±0.1%、空腹血糖升高11.0±12.7毫克/分升相比，每日两次10微克的艾塞那肽单药治疗28天可使糖化血红蛋白平均显著降低-0.4±0.1%，空腹血糖降低-36.1±11.0毫克/分升。自我监测的血糖曲线显示，与安慰剂相比，接受艾塞那肽治疗的患者每日血糖浓度平均显著降低。在一项开放标签扩展研究中，艾塞那肽治疗30周后，单纯接受饮食及运动治疗的患者（糖化血红蛋白和体重分别从基线平均降低-1.0±0.2%和-4.3±1.3千克）与接受二甲双胍治疗的患者（糖化血红蛋白和体重分别从基线平均降低-0.9±0.1%和-3.7±0.5千克）相比，糖化血红蛋白和体重从基线的平均降低幅度相似。在两项研究中，最常见的不良事件是胃肠道事件，且主要为轻度至中度。轻度至中度低血糖的发生率较低，无严重低血糖事件。
在2型糖尿病患者中，每日两次的艾塞那肽单药治疗在改善血糖和减轻体重方面与艾塞那肽联合二甲双胍治疗相当。
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