Eli Lilly's Weekly Insulin Dose On Par With Commonly Used Daily Doses, Phase 3 Studies Show
Eli Lilly's Weekly Insulin Dose On Par With Commonly Used Daily Doses, Phase 3 Studies Show
Eli Lilly and Co (NYSE:LLY) released Thursday topline results from two phase 3 trials.
礼来公司(纽约证券交易所代码:LLY)周四公布了两项3期试验的头条结果。
The drugmaker evaluated once-weekly insulin efsitora alfa (efsitora) in type 2 diabetes patients using insulin for the first time (insulin naïve) and those who require multiple daily insulin injections.
该制药商对首次使用胰岛素(胰岛素天真)和每天需要多次注射胰岛素的2型糖尿病患者每周一次的efsitora alfa(efsitora)胰岛素(efsitora)进行了评估。
In the treat-to-target clinical trials, efsitora showed non-inferior A1C reduction compared to the most commonly used daily basal insulins globally.
在以治疗为目标的临床试验中,与全球最常用的每日基础胰岛素相比,efsitora的A1C降幅不逊色。
QWINT-2 evaluated the efficacy and safety of once-weekly efsitora compared to once-daily insulin degludec for 52 weeks.
QWINT-2 评估了每周一次的 efsitora 与 52 周内每天服用一次胰岛素消毒剂的疗效和安全性。
The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 52.
该试验在第52周达到了其主要终点,即使用efsitora与去除胰岛素相比,使用efsitora减少A1C的效果不差。
For the efficacy estimand, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95%, respectively.
就疗效评估而言,efsitora将A1C降低了1.34%,而胰岛素degludec的A1C为1.26%,使A1C分别降低了6.87%和6.95%。
In a key secondary endpoint, efsitora was non-inferior to insulin degludec in A1C change among participants using and not using GLP-1 receptor agonists.
在关键的次要终点中,在使用和不使用 GLP-1 受体激动剂的参与者中,efsitora 在 A1C 变化方面均不逊于胰岛素 degludec。
Further, participants taking efsitora spent 45 minutes more time in range and 37 minutes more in tight range without additional time in hypoglycemia (blood glucose <54 mg/dL) compared to insulin degludec.
此外,与去角胰岛素相比,服用 efsitora 的参与者在射程内停留的时间延长了 45 分钟,在没有额外时间出现低血糖(血糖
QWINT-4 evaluated the efficacy and safety of efsitora compared to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin.
对于之前接受过基础胰岛素治疗和每天至少注射两次进餐时胰岛素的 2 型糖尿病成人,QWINT-4 评估了 efsitora 与甘精胰岛素对比 26 周的疗效和安全性。
For the efficacy estimand, efsitora and insulin glargine reduced A1C by 1.07% resulting in an A1C of 7.12% and 7.11%, respectively.
根据疗效估计,efsitora和甘精胰岛素使A1C降低了1.07%,使A1C分别降低了7.12%和7.11%。
In QWINT-2 and QWINT-4, efsitora was safe and well-tolerated.
在 QWINT-2 和 QWINT-4 中,efsitora 安全且耐受性良好。
The estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure were 0.58 with efsitora vs. 0.45 with insulin degludec (QWINT-2) and 6.6 with efsitora vs. 5.9 with insulin glargine (QWINT-4).
据估计,efsitora患者每年的严重或临床上显著的降糖事件的综合发生率为0.58,而德格列德克胰岛素(QWINT-2)的合并发生率为0.45,efsitora的合并发生率为6.6,甘精胰岛素(QWINT-4)为5.9。
Topline readouts from QWINT-1, QWINT-3, and QWINT-5 are anticipated later this year.
QWINT-1、QWINT-3 和 QWINT-5 的头条数据预计将于今年晚些时候公布。
Price Action: LLY shares are down 0.43% at $783.65 at last check Thursday.
价格走势:周四最后一次检查时,LLY股价下跌0.43%,至783.65美元。
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Image: Shutterstock
图片:Shutterstock
译文内容由第三方软件翻译。