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Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment.
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-09-10 , DOI: 10.1056/nejmoa2403953 Carol Wysham 1 , Harpreet S Bajaj 1 , Stefano Del Prato 1 , Denise Reis Franco 1 , Arihiro Kiyosue 1 , Dominik Dahl 1 , Chunmei Zhou 1 , Molly C Carr 1 , Michael Case 1 , Livia Firmino Gonçalves 1 ,
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-09-10 , DOI: 10.1056/nejmoa2403953 Carol Wysham 1 , Harpreet S Bajaj 1 , Stefano Del Prato 1 , Denise Reis Franco 1 , Arihiro Kiyosue 1 , Dominik Dahl 1 , Chunmei Zhou 1 , Molly C Carr 1 , Michael Case 1 , Livia Firmino Gonçalves 1 ,
Affiliation
BACKGROUND
Insulin efsitora alfa (efsitora) is a new basal insulin designed for once-weekly administration. Data on safety and efficacy have been limited to small, phase 1 or phase 2 trials.
METHODS
We conducted a 52-week, phase 3, parallel-design, open-label, treat-to-target trial involving adults with type 2 diabetes who had not previously received insulin. Participants were randomly assigned in a 1:1 ratio to receive efsitora or degludec. The primary end point was the change in the glycated hemoglobin level from baseline to week 52; we hypothesized that efsitora would be noninferior to degludec (noninferiority margin, 0.4 percentage points). Secondary and safety end points included the change in the glycated hemoglobin level in subgroups of participants using and not using glucagon-like peptide-1 (GLP-1) receptor agonists, the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter in weeks 48 through 52, and hypoglycemic episodes.
RESULTS
A total of 928 participants underwent randomization (466 to the efsitora group and 462 to the degludec group). The mean glycated hemoglobin level decreased from 8.21% at baseline to 6.97% at week 52 with efsitora (least-squares mean change, -1.26 percentage points) and from 8.24% to 7.05% with degludec (least-squares mean change, -1.17 percentage points) (estimated treatment difference, -0.09 percentage points; 95% confidence interval [CI], -0.22 to 0.04), findings that showed noninferiority. Efsitora was noninferior to degludec with respect to the change in the glycated hemoglobin level in participants using and not using GLP-1 receptor agonists. The percentage of time that the glucose level was within the target range was 64.3% with efsitora and 61.2% with degludec (estimated treatment difference, 3.1 percentage points; 95% CI, 0.1 to 6.1). The rate of combined clinically significant or severe hypoglycemia was 0.58 events per participant-year of exposure with efsitora and 0.45 events per participant-year of exposure with degludec (estimated rate ratio, 1.30; 95% CI, 0.94 to 1.78). No severe hypoglycemia was reported with efsitora; six episodes were reported with degludec. The incidence of adverse events was similar in the two groups.
CONCLUSIONS
In adults with type 2 diabetes who had not previously received insulin, once-weekly efsitora was noninferior to once-daily degludec in reducing glycated hemoglobin levels. (Funded by Eli Lilly; QWINT-2 ClinicalTrials.gov number, NCT05362058.).
中文翻译:
Efsitora 胰岛素与 Degludec 在既往未接受过胰岛素治疗的 2 型糖尿病中的比较。
背景 efsitora alfa (efsitora) 是一种新型基础胰岛素,设计用于每周一次给药。关于安全性和有效性的数据仅限于小型 1 期或 2 期试验。方法 我们进行了一项为期 52 周的 3 期、平行设计、开放标签、靶向治疗试验,涉及以前未接受过胰岛素治疗的 2 型糖尿病成人患者。参与者以 1:1 的比例随机分配接受 efsitora 或 degludec。主要终点是糖化血红蛋白水平从基线到第 52 周的变化;我们假设 efsitora 不劣于 Degludec (非劣效性边际,0.4 个百分点)。次要和安全终点包括使用和不使用胰高血糖素样肽-1 (GLP-1) 受体激动剂的参与者亚组糖化血红蛋白水平的变化,第 48 周至第 52 周葡萄糖水平在 70 至 180 毫克/分升目标范围内的时间百分比,以及低血糖发作。结果 共有 928 名参与者接受了随机分组 (efsitora 组 466 名,degludec 组 462 名)。平均糖化血红蛋白水平从基线时的 8.21% 下降到第 52 周的 6.97%(最小二乘平均变化,-1.26 个百分点),degludec 的平均糖化血红蛋白水平从 8.24% 下降到 7.05%(最小二乘平均变化,-1.17 个百分点)(估计治疗差异,-0.09 个百分点;95% 置信区间 [CI],-0.22 至 0.04),结果显示非劣效性。在使用和不使用 GLP-1 受体激动剂的参与者的糖化血红蛋白水平变化方面,Efsitora 不劣于 degludec。efsitora 和 61 的葡萄糖水平在目标范围内的时间百分比为 64.3%。2% 患有 degludec 患者(估计治疗差异,3.1 个百分点;95% CI,0.1 至 6.1)。联合临床显着或严重低血糖的发生率为 efsitora 每参与者年 0.58 个事件,degludec 每个参与者每年暴露 0.45 个事件(估计比率,1.30;95% CI,0.94 至 1.78)。efsitora 未报告严重低血糖;据报道,Degludec 组有 6 次发作。两组不良事件的发生率相似。结论 在既往未接受胰岛素治疗的 2 型糖尿病成人患者中,每周一次的 efsitora 在降低糖化血红蛋白水平方面不劣于每日一次的 degludec。(由 Eli Lilly 资助;QWINT-2 ClinicalTrials.gov 号,NCT05362058.)。
更新日期:2024-09-10
中文翻译:
Efsitora 胰岛素与 Degludec 在既往未接受过胰岛素治疗的 2 型糖尿病中的比较。
背景 efsitora alfa (efsitora) 是一种新型基础胰岛素,设计用于每周一次给药。关于安全性和有效性的数据仅限于小型 1 期或 2 期试验。方法 我们进行了一项为期 52 周的 3 期、平行设计、开放标签、靶向治疗试验,涉及以前未接受过胰岛素治疗的 2 型糖尿病成人患者。参与者以 1:1 的比例随机分配接受 efsitora 或 degludec。主要终点是糖化血红蛋白水平从基线到第 52 周的变化;我们假设 efsitora 不劣于 Degludec (非劣效性边际,0.4 个百分点)。次要和安全终点包括使用和不使用胰高血糖素样肽-1 (GLP-1) 受体激动剂的参与者亚组糖化血红蛋白水平的变化,第 48 周至第 52 周葡萄糖水平在 70 至 180 毫克/分升目标范围内的时间百分比,以及低血糖发作。结果 共有 928 名参与者接受了随机分组 (efsitora 组 466 名,degludec 组 462 名)。平均糖化血红蛋白水平从基线时的 8.21% 下降到第 52 周的 6.97%(最小二乘平均变化,-1.26 个百分点),degludec 的平均糖化血红蛋白水平从 8.24% 下降到 7.05%(最小二乘平均变化,-1.17 个百分点)(估计治疗差异,-0.09 个百分点;95% 置信区间 [CI],-0.22 至 0.04),结果显示非劣效性。在使用和不使用 GLP-1 受体激动剂的参与者的糖化血红蛋白水平变化方面,Efsitora 不劣于 degludec。efsitora 和 61 的葡萄糖水平在目标范围内的时间百分比为 64.3%。2% 患有 degludec 患者(估计治疗差异,3.1 个百分点;95% CI,0.1 至 6.1)。联合临床显着或严重低血糖的发生率为 efsitora 每参与者年 0.58 个事件,degludec 每个参与者每年暴露 0.45 个事件(估计比率,1.30;95% CI,0.94 至 1.78)。efsitora 未报告严重低血糖;据报道,Degludec 组有 6 次发作。两组不良事件的发生率相似。结论 在既往未接受胰岛素治疗的 2 型糖尿病成人患者中,每周一次的 efsitora 在降低糖化血红蛋白水平方面不劣于每日一次的 degludec。(由 Eli Lilly 资助;QWINT-2 ClinicalTrials.gov 号,NCT05362058.)。