Eli Lilly's Once-Weekly Insulin Trials Show Similar A1C Reduction As Daily Doses, Improving Diabetes Management Potential
Eli Lilly's Once-Weekly Insulin Trials Show Similar A1C Reduction As Daily Doses, Improving Diabetes Management Potential
Eli Lilly and Company (NYSE:LLY) today announced positive topline results from the QWINT-1 and QWINT-3 phase 3 clinical trials evaluating once weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes using basal insulin for the first time (insulin naïve) and in those who have switched from daily basal insulin injections, respectively. In these long-term treat-to-target trials, efsitora showed non-inferior A1C reduction compared to the most frequently used daily basal insulins globally.
今日,Lilly醫藥公司(NYSE:LLY)宣佈QWINt-1和QWINt-3兩個III期臨床試驗評估一週一次的胰島素開多(efsitora alfa)用於剛開始使用基礎胰島素的2型糖尿病成年患者(胰島素未經過)以及那些從每天注射基礎胰島素切換過來的成年患者的初步積極結果。在這些長期指向目標的治療試驗中,efsitora和全球最常用的每天的基礎胰島素相比,顯示出非劣性A1C減少。
QWINT-1 evaluated the efficacy and safety of once weekly efsitora compared to once daily insulin glargine for 52 weeks. The trial randomized adults with type 2 diabetes who are insulin naïve to receive either efsitora once weekly in a single-use autoinjector or insulin glargine once daily. Efsitora was titrated across four fixed doses1 at four-week intervals, as needed for blood glucose control. The study's goal was to provide data supporting real-life applications of fixed dose regimens, which have the potential to make it easier for people living with diabetes to start and manage insulin therapy.
QWINt-1評估了一週一次efsitora與一天一次的胰島素加飼料對52周的療效和安全性。該試驗隨機將2型糖尿病未注射胰島素的成年患者分爲兩組,一組使用一週一次efistora(一次性自動注射器),另一組使用一天一次的胰島素加飼料。efistora根據血糖控制需要,在四周間隔內調整四種固定劑量。該研究的目標是提供支持真實世界應用的固定劑量方案的數據,這有助於爲糖尿病患者開始和管理胰島素治療提供便利。
The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 52. For the efficacy estimand2,3, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine, resulting in an A1C of 6.92% and 6.96%, respectively4. For the treatment-regimen estimand5,6, efsitora reduced A1C by 1.19% compared to 1.16% for insulin glargine, resulting in an A1C of 7.05% and 7.08%, respectively4.
該試驗在52周時,efsitora與胰島素加飼料相比在非劣性A1C減少方面達到了主要終點。對於效能的估計2,3,efsitora將A1C減少1.31%,胰島素加飼料減少1.27%,結果分別爲6.92%和6.96%4。對於治療方案的估計5,6,efsitora將A1C減少1.19%,胰島素加飼料減少1.16%,結果分別爲7.05%和7.08%4。
QWINT-3 evaluated the efficacy and safety of once weekly efsitora compared to once daily insulin degludec for 78 weeks in adults with type 2 diabetes currently treated with basal insulin. Participants were randomized 2:1 to receive either efsitora once weekly or insulin degludec once daily.
QWINt-3評估了一週一次efsitora與一天一次的胰島素degludec對78周的2型糖尿病成年患者的療效和安全性。參與者被2:1的比例隨機分配,其中一組接受一週一次的efsitora,另一組接受一天一次的胰島素degludec。
The QWINT-3 trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 26. For the efficacy estimand7, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec resulting in an A1C of 6.93% and 7.03%, respectively8. For the treatment-regimen estimand9, efsitora reduced A1C by 0.81% compared to 0.72% for insulin degludec resulting in an A1C of 6.99% and 7.08%, respectively10.
QWINt-3試驗在26周時,efsitora與胰島素degludec相比,在非劣性A1C減少方面達到了主要終點。對於效能的估計7,efsitora將A1C減少0.86%,胰島素degludec減少0.75%,結果分別爲6.93%和7.03%8。對於治療方案的估計9,10,efsitora將A1C減少0.81%,胰島素degludec減少0.72%,結果分別爲6.99%和7.08%。
Additionally, participants taking efsitora or insulin degludec spent approximately two hours more time in range (glucose 70-180 mg/dL) per day for weeks 22-26 compared to baseline. For the efficacy estimand11, participants taking efsitora spent 62.8% of time in range compared to 61.3% for insulin degludec for weeks 22-2612. For the treatment-regimen estimand13, participants taking efsitora spent 61.4% of time in range compared to 61% for insulin degludec14. Further, for the efficacy estimand, participants taking efsitora spent 38.3% of time in tight range (glucose 70-140 mg/dL) compared to 36.8% for insulin degludec for weeks 22-2615.
此外,與基線相比,接受efsitora或胰島素degludec的參與者在第22-26周的每天區間時間(血糖70-180 mg/dL)增加了約兩個小時。對於有效性評估,與胰島素degludec相比,接受efsitora的參與者在第22-26周的區間時間佔比爲62.8%,而胰島素degludec爲61.3%12。對於治療方案評估,與胰島素degludec相比,接受efsitora的參與者在第22-2613周的區間時間佔比爲61.4%,而胰島素degludec爲61%14。此外,對於有效性評估,與胰島素degludec相比,接受efsitora的參與者在第22-2615周的嚴格區間時間(血糖70-140 mg/dL)佔比爲38.3%,而胰島素degludec爲36.8%。
In both QWINT-1 and QWINT-3, the overall safety and tolerability profile of efsitora was similar to that of daily basal insulin therapies for the treatment of type 2 diabetes. In QWINT-1, estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL) hypoglycemic events per patient-year of exposure from weeks 0-52 were 0.50 with efsitora vs. 0.88 with insulin glargine – approximately 40% lower with efsitora than insulin glargine. In QWINT-3, estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL) hypoglycemic events per patient-year of exposure from weeks 0-78 were 0.84 with efsitora vs. 0.74 with insulin degludec.
在QWINt-1和QWINt-3中,efsitora的整體安全性和耐受性與用於治療2型糖尿病的日常基礎胰島素療法相似。在QWINt-1中,來自0-52周暴露的患者的嚴重或臨床意義(血糖