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首页> 外文期刊>Diabetes care >Efficacy and safety of the once-weekly GLP-1 receptor agonist albiglutide versus sitagliptin in patients with type 2 diabetes and renal impairment: A randomized phase III study
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Efficacy and safety of the once-weekly GLP-1 receptor agonist albiglutide versus sitagliptin in patients with type 2 diabetes and renal impairment: A randomized phase III study

机译：每周一次的GLP-1受体激动剂阿比鲁肽与西他列汀在2型糖尿病和肾功能不全患者中的疗效和安全性：一项随机的III期研究

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OBJECTIVE To evaluate weekly subcutaneous albiglutide versus daily sitagliptin in renally impaired patients with type 2 diabetes and inadequately controlled glycemia on a regimen of diet and exercise and/or oral antihyperglycemic medications.RESEARCH DESIGN AND METHODS In this phase III, randomized, double-blind, multicenter, 52-week study, the primary study end point was HbA1c change from baseline at week 26 in patients with renal impairment, as assessed with estimated glomerular filtration rate and categorized as mild, moderate, or severe (≥60 to ≤89, ≥30 to ≤59, and ≥15 to ≤29 mL/min/1.73 m2, respectively). Secondary end points included fasting plasma glucose (FPG), weight, achievement of treatment targets, hyperglycemic rescue, and safety.RESULTS Baseline demographics were similar across treatment and renal impairment groups with overall mean age of 63.3 years, BMI of 30.4 kg/m2, HbA1c of 8.2% (66 mmol/mol), and diabetes disease duration of 11.2 years. HbA1c change from baseline at week 26 was significantly greater for albiglutide than sitagliptin (20.83% vs. 20.52%, P = 0.0003). Decreases in HbA1c, FPG, and weight were seen through week 52. Time to hyperglycemic rescue through week 52was significantly longer for albiglutide than sitagliptin (P = 0.0017). Results of safety assessments were similar between groups, and most adverse events (AEs) were mild or moderate. The incidences of gastrointestinal AEs for albiglutide and sitagliptin were as follows: overall, 31.7%, 25.2%; diarrhea, 10.0%, 6.5%; nausea, 4.8%, 3.3%; and vomiting, 1.6%, 1.2%, respectively.CONCLUSIONS Once-weekly albiglutide therapy in renally impaired patients with type 2 diabetes provided statistically superior glycemic improvement with almost similar tolerability compared with daily sitagliptin therapy.
机译：目的通过饮食，运动和/或口服降糖药方案评估肾功能不全的2型糖尿病和肾功能不全患者的每周皮下阿比鲁肽与每日西他列汀比较。研究设计和方法一项多中心，为期52周的研究，主要研究终点是肾功能不全患者在第26周时从基线开始的HbA1c变化，该估计值是通过估计的肾小球滤过率评估的，分为轻度，中度或重度（≥60至≤89，≥ 30至≤59和≥15至≤29mL / min / 1.73 m2）。次要终点包括空腹血糖（FPG），体重，治疗目标达成情况，高血糖抢救和安全性。结果治疗组和肾功能不全组的基线人口统计学特征相似，总平均年龄为63.3岁，BMI为30.4 kg / m2， HbA1c为8.2％（66 mmol / mol），糖尿病病程为11.2年。阿比鲁肽在第26周时自基线的HbA1c变化显着大于西他列汀（20.83％对20.52％，P = 0.0003）。到第52周，HbA1c，FPG和体重均下降。到52周为止，高糖挽救时间明显比西他列汀长（P = 0.0017）。两组之间的安全性评估结果相似，并且大多数不良事件（AE）为轻度或中度。阿比鲁肽和西他列汀在胃肠道不良事件中的发生率分别为：总的31.7％，25.2％;腹泻，10.0％，6.5％;恶心，4.8％，3.3％;结论每周一次的阿比鲁肽治疗肾功能不全的2型糖尿病患者，与每日西他列汀治疗相比，在血糖改善方面具有统计学上的优越性，并且耐受性几乎相似。

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