Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes - A randomized trial
Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes - A randomized trial
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DOI：
10.7326/0003-4819-143-8-200510180-00006
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发表时间：
2005-10-18
影响因子：
39.2
通讯作者：
Brodows, RG
中科院分区：
文献类型：
--
作者：
Heine, RJ;Van Gaal, LF;Brodows, RG
背景：对于口服降糖药但血糖控制不佳的2型糖尿病患者，医生可以使用胰岛素或艾塞那肽注射。目的：比较艾塞那肽和甘精胰岛素对二甲双胍和磺脲类药物次优控制的2型糖尿病患者血糖控制的影响。设计：26周的多中心开放随机对照试验。地点：13个国家的82个门诊研究中心。患者：551名2型糖尿病患者，尽管联合使用二甲双胍和磺脲类药物，但血糖控制不佳(定义为糖蛋白A(1c)水平在7.0%到10.0%之间)。治疗。干预：试验组每日2次10 mg，或甘精胰岛素每日1次滴定，以维持空腹血糖低于5.6 mmol/L(100 mg/dL)。测量：血红蛋白A(1c)水平、空腹血糖水平、体重、7点自我监测血糖、标准化试餐挑战、安全性和耐受性。结果：服用艾塞那肽的患者基线平均血红蛋白A(1c)水平为8.2%，接受甘精胰岛素治疗的患者为8.3%。在第26周，埃塞那肽和甘精胰岛素都使Hb Ale水平降低了1.11%(差异为0.017个百分点[95%CI，-0.123至0.157个百分点])。艾塞那肽比甘精胰岛素更能减少餐后血糖漂移，而甘精胰岛素比艾塞那肽更能降低空腹血糖浓度。体重下降2.3公斤，甘精胰岛素增加1.8公斤(相差-4.1公斤[氯，-4.6至-3.5公斤])。有症状的低血糖发生率相似，但试验组发生夜间低血糖的频率较低(0.9事件/患者年比2.4事件/患者年；差异，-1.6事件/患者年[CL，-2.3至-0.9事件/患者年])。胃肠道症状在试验组比甘精胰岛素组更常见，包括恶心(57.1%比8.6%)、呕吐(17.4%比3.7%)和腹泻(8.5%比3.0%)。限制：这项试验是开放的，不评估与糖尿病相关的临床并发症。在551名参与者中，19.4%的服用埃克那西汀的人和9.7%的服用甘精胰岛素的人退出了研究。仅有21.6%的甘精胰岛素组和8.6%的艾塞那汀组达到了空腹血糖<5.6 mmol/L(100 mg/dL)的目标水平。结论：艾塞那肽和甘精胰岛素对2型糖尿病患者的总体血糖控制效果相似，但口服联合治疗效果不佳。埃塞那肽与体重减轻有关，胃肠道不良反应的发生率高于甘精胰岛素。
Background: Physicians may use either insulin or exenatide injections for patients with type 2 diabetes mellitus who have poor glycemic control despite taking oral blood glucose-lowering drugs.Objective: To compare effects of exenatide and insulin glargine on glycemic control in patients with type 2 diabetes mellitus that is suboptimally controlled with metformin and a sulfonylurea.Design: 26-week multicenter, open-label, randomized, controlled trial.Setting: 82 outpatient study centers in 13 countries.Patients: 551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A(1c) level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea. therapy.Intervention: Exenaticle, 10 mu g twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (< 100 mg/dL).Measurements: Hemoglobin A(1c) level, fasting plasma glucose level, body weight, 7-point self-monitored blood glucose, standardized test-meal challenge, safety, and tolerability.Results: Baseline mean hemoglobin A(1c) level was 8.2% for patients receiving exenatide and 8.3% for those receiving insulin glargine. At week 26, both exenatide and insulin glargine reduced hemoglobin Ale levels by 1.11% (difference, 0.017 percentage point [95% Cl, -0.123 to 0.157 percentage point]). Exenatide reduced postprandial glucose excursions more than insulin glargine, while insulin glargine reduced fasting glucose concentrations more than exenatide. Body weight decreased 2.3 kg with exenaticle and increased 1.8 kg with insulin glargine (difference, -4.1 kg [Cl, -4.6 to -3.5 kg]). Rates of symptomatic hypoglycemia were similar, but nocturnal hypoglycemia occurred less frequently with exenaticle (0.9 event/patient-year versus 2.4 events/ patient-year; difference, -1.6 events/patient-year [Cl, -2.3 to -0.9 event/patient year]). Gastrointestinal symptoms were more common in the exenaticle group than in the insulin glargine group, including nausea (57.1% vs. 8.6%), vomiting (17.4% vs. 3.7%) and diarrhea (8.5% vs. 3.0%).Limitations: The trial was open-label and did not assess clinical complications related to diabetes. Of the 551 participants, 19.4% of those receiving exenaticle and 9.7% of those receiving insulin glargine withdrew from the study. Only 21.6% of the insulin glargine group and 8.6% of the exenaticle group achieved the target level for fasting plasma glucose of less than 5.6 mmol/L (< 100 mg/dL).Conclusions: Exenatide and insulin glargine achieved similar improvements in overall glycemic control in patients with type 2 diabetes that was suboptimally controlled with oral combination therapy. Exenatide was associated with weight reduction and had a higher incidence of gastrointestinal adverse effects than insulin glargine.