OBJECTIVE Approved treatments for type 2 diabetes in pediatric patients include metformin, liraglutide, and insulin. However, approximately one-half of the youth fail metformin monotherapy within 1 year, insulin therapy is associated with challenges, and liraglutide requires daily injections. Consequently, the efficacy and safety of once-weekly injections of exenatide for the treatment of youth with type 2 diabetes was evaluated. RESEARCH DESIGN AND METHODS Participants (aged 10 to <18 years) were randomized (5:2) to once-weekly exenatide 2 mg or placebo, respectively. The primary efficacy end point was change in glycated hemoglobin from baseline to week 24. Secondary efficacy end points were also evaluated, and the frequency of adverse events (AEs) was assessed. RESULTS A total of 83 participants were randomized (exenatide, 59; placebo, 24) and 72 completed 24-week treatment (exenatide, 49; placebo, 23). At 24 weeks, the least squares mean change in glycated hemoglobin was −0.36% for the exenatide and +0.49% for the placebo groups (between-group difference, −0.85%; 95% CI −1.51, −0.19; P = 0.012). Nonsignificant least squares mean differences from baseline to 24 weeks favoring exenatide were observed: fasting glucose −21.6 mg/dL (−49.0, 5.7; P = 0.119), systolic blood pressure −2.8 mmHg (−8.0, 2.4; P = 0.284), and body weight −1.22 kg (−3.59, 1.15; P = 0.307). AEs occurred in 36 (61.0%) and 17 (73.9%) participants in the exenatide and placebo groups, respectively. CONCLUSIONS In youth with type 2 diabetes suboptimally controlled with current treatments, once-weekly exenatide reduced glycated hemoglobin at 24 weeks and was well tolerated.

中文翻译：

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2 型糖尿病青年每周一次艾塞那肽

目的 经批准的治疗儿科患者 2 型糖尿病的药物包括二甲双胍、利拉鲁肽和胰岛素。然而，大约一半的年轻人在 1 年内单用二甲双胍治疗失败，胰岛素治疗与挑战相关，利拉鲁肽需要每天注射。因此，评估了每周注射一次艾塞那肽治疗青年 2 型糖尿病的疗效和安全性。研究设计和方法 参与者（10 至 <18 岁）被随机分配 (5:2) 分别接受每周一次的艾塞那肽 2 mg 或安慰剂。主要疗效终点是糖化血红蛋白从基线到第 24 周的变化。还评估了次要疗效终点，并评估了不良事件 (AE) 的频率。结果 共有 83 名参与者被随机分配（艾塞那肽，59 人；安慰剂，24) 和 72 人完成了 24 周的治疗（艾塞那肽，49 人；安慰剂，23 人）。24 周时，艾塞那肽组糖化血红蛋白的最小二乘平均变化为 -0.36%，安慰剂组为 +0.49%（组间差异，-0.85%；95% CI -1.51，-0.19；P = 0.012） . 观察到从基线到 24 周有利于艾塞那肽的非显着最小二乘平均差异：空腹血糖 -21.6 mg/dL（-49.0，5.7；P = 0.119），收缩压 -2.8 mmHg（-8.0，2.4；P = 0.284），和体重 -1.22 公斤（-3.59，1.15；P = 0.307）。艾塞那肽组和安慰剂组分别有 36 名 (61.0%) 和 17 名 (73.9%) 参与者发生 AE。结论 在目前治疗未达到最佳控制的 2 型糖尿病青年中，每周一次的艾塞那肽在 24 周时降低了糖化血红蛋白，并且耐受性良好。