Texas Diabetes and Endocrinology, 6500 North Mopac Expressway, Building 3, Suite 200, Austin, Texas 78731, USA.
J Clin Endocrinol Metab. 2011 May;96(5):1301-10. doi: 10.1210/jc.2010-2081. Epub 2011 Feb 9.
We wanted to understand the effects of once-weekly vs. twice-daily glucagon-like peptide-1 receptor agonism for treatment of patients with type 2 diabetes.
The objective of the study was to compare effects of exenatide once weekly (ExQW) and exenatide twice daily (ExBID) on glycemic control, body weight, and safety.
This was a 24-wk, randomized, open-label, comparator-controlled study.
The study was conducted at 43 sites in the United States.
The study population was 252 intent-to-treat patients with type 2 diabetes [baseline (mean ± SD): glycosylated hemoglobin (HbA1c) 8.4 ± 1.2%, fasting plasma glucose 171 ± 47 mg/dl, weight 96 ± 20 kg] that were drug naïve (19%) or previously treated with one (47%) or multiple (35%) oral antidiabetic medications.
Interventions included ExQW 2 mg for 24 wk or ExBID 5 μg for 4 wk followed by ExBID 10 μg for 20 wk.
The change in HbA1c from baseline to wk 24 was measured.
At 24 wk, ExQW produced significantly greater changes from baseline (least squares mean ± SE) vs. ExBID in HbA1c (-1.6 ± 0.1% vs. -0.9 ± 0.1%; P < 0.0001) and fasting plasma glucose (-35 ± 5 mg/dl vs. -12 ± 5 mg/dl; P = 0.0008). Similar reductions in mean body weight from baseline to wk 24 were observed in both groups (-2.3 ± 0.4 kg and -1.4 ± 0.4 kg). Both treatments were generally well tolerated. Transient and predominantly mild to moderate nausea, the most frequent adverse event, was less common with ExQW (14%) than with ExBID (35%). Injection-site reactions were infrequent, but more common with ExQW. No major hypoglycemia occurred.
Continuous glucagon-like peptide-1 receptor agonism with ExQW resulted in superior glycemic control, with less nausea, compared with ExBID in patients with type 2 diabetes. Both groups lost weight.
我们想了解每周一次与每日两次胰高血糖素样肽-1 受体激动剂治疗 2 型糖尿病患者的效果。
本研究旨在比较每周一次艾塞那肽（ExQW）和每日两次艾塞那肽（ExBID）对血糖控制、体重和安全性的影响。
这是一项为期 24 周的随机、开放标签、对照研究。
该研究在美国 43 个地点进行。
研究人群为 252 名 2 型糖尿病意向治疗患者[基线（均值 ± SD）：糖化血红蛋白（HbA1c）8.4 ± 1.2%，空腹血糖 171 ± 47 mg/dl，体重 96 ± 20 kg]，他们为药物初治（19%）或以前使用过一种（47%）或多种（35%）口服抗糖尿病药物。
干预措施包括 ExQW 2 mg 治疗 24 周或 ExBID 5 μg 治疗 4 周，随后 ExBID 10 μg 治疗 20 周。
从基线到第 24 周时 HbA1c 的变化。
在 24 周时，ExQW 与 ExBID 相比，HbA1c 从基线的变化（最小二乘均值 ± SE）明显更大（-1.6 ± 0.1% vs. -0.9 ± 0.1%；P < 0.0001）和空腹血糖（-35 ± 5 mg/dl vs. -12 ± 5 mg/dl；P = 0.0008）。两组从基线到第 24 周的平均体重均有相似的下降（-2.3 ± 0.4 kg 和 -1.4 ± 0.4 kg）。两种治疗方法均具有良好的耐受性。最常见的不良事件是短暂的、主要为轻度至中度的恶心，ExQW（14%）比 ExBID（35%）少见。注射部位反应少见，但 ExQW 更常见。无严重低血糖事件发生。
与每日两次 ExBID 相比，在 2 型糖尿病患者中，每周一次 ExQW 持续给予胰高血糖素样肽-1 受体激动剂可更好地控制血糖，恶心发生率更低。两组患者体重均减轻。
