Once-weekly dose of insulin efsitora alfa delivers A1C reduction consistent with the most advanced daily insulin in people with type 2 diabetes
Eli Lilly and Company (NYSE: LLY) has announced promising results from the QWINT-2 phase 3 trial of once-weekly insulin efsitora alfa compared to once-daily insulin degludec in adults with type 2 diabetes. The study, published in The New England Journal of Medicine and presented at EASD 2024, showed that efsitora met its primary endpoint of non-inferior A1C reduction. Key findings include:
- Efsitora reduced A1C by 1.34% vs. 1.26% for insulin degludec
- Participants achieved 45 minutes more time in range per day with efsitora
- No severe hypoglycemic events were reported with efsitora
- Efsitora demonstrated a safety profile similar to daily insulins
These results suggest efsitora could offer a convenient once-weekly option for type 2 diabetes patients, potentially improving treatment adherence while providing comparable outcomes to daily insulins.
Eli Lilly and Company (NYSE: LLY) ha annunciato risultati promettenti dallo studio di fase 3 QWINT-2 riguardante l'insulina efsitora alfa somministrata una volta alla settimana rispetto all'insulina degludec somministrata una volta al giorno negli adulti con diabete di tipo 2. Lo studio, pubblicato nel New England Journal of Medicine e presentato all'EASD 2024, ha dimostrato che l'efsitora ha raggiunto il suo obiettivo primario di riduzione A1C non inferiore. I principali risultati includono:
- L'efsitora ha ridotto l'A1C dell'1,34% rispetto all'1,26% per l'insulina degludec
- I partecipanti hanno ottenuto 45 minuti in più di tempo in range al giorno con l'efsitora
- Non sono stati riportati eventi ipoglicemici gravi con l'efsitora
- L'efsitora ha mostrato un profilo di sicurezza simile a quello delle insuline quotidiane
Questi risultati suggeriscono che l'efsitora potrebbe offrire un'opzione conveniente di somministrazione settimanale per i pazienti con diabete di tipo 2, potenzialmente migliorando l'aderenza al trattamento e fornendo risultati comparabili a quelli delle insuline giornaliere.
Eli Lilly and Company (NYSE: LLY) ha anunciado resultados prometedores del ensayo clínico de fase 3 QWINT-2 sobre la insulina efsitora alfa administrada una vez a la semana en comparación con la insulina degludec administrada una vez al día en adultos con diabetes tipo 2. El estudio, publicado en el New England Journal of Medicine y presentado en el EASD 2024, mostró que la efsitora cumplió con su objetivo principal de reducción A1C no inferior. Los hallazgos clave incluyen:
- La efsitora redujo la A1C en un 1.34% frente al 1.26% de la insulina degludec
- Los participantes lograron 45 minutos más de tiempo en rango por día con la efsitora
- No se informaron eventos hipoglucémicos severos con la efsitora
- La efsitora demostró un perfil de seguridad similar al de las insulinas diarias
Estos resultados sugieren que la efsitora podría ofrecer una opción conveniente de administración semanal para pacientes con diabetes tipo 2, mejorando potencialmente la adherencia al tratamiento mientras se proporcionan resultados comparables a los de las insulinas diarias.
엘리 릴리 앤 컴퍼니 (NYSE: LLY)는 제2형 당뇨병 성인의 주 1회 인슐린 에프시토라 알파와 주 1회 인슐린 데글루덱을 비교한 QWINT-2 3상 시험의 유망한 결과를 발표했습니다. 이 연구는 뉴잉글랜드 의학 저널에 게재되었고 EASD 2024에서 발표되었습니다. 에프시토라는 A1C 감소의 비열등성을 충족했습니다. 주요 결과는 다음과 같습니다:
- 에프시토라는 인슐린 데글루덱에 비해 A1C를 1.34% 감소시켰습니다 (1.26%)
- 참가자들은 에프시토라로 하루 평균 45분 더 범위 내에 있었습니다
- 에프시토라로 심각한 저혈당 사건이 보고되지 않았습니다
- 에프시토라는 매일 투여하는 인슐린과 유사한 안전성 프로필을 보였습니다
이 결과는 에프시토라가 제2형 당뇨병 환자에게 편리한 주 1회 옵션을 제공할 수 있음을 시사하며, 일일 인슐린과 유사한 결과를 제공하면서 치료 순응도를 개선할 수 있습니다.
Eli Lilly and Company (NYSE: LLY) a annoncé des résultats prometteurs de l'essai clinique de phase 3 QWINT-2 sur l'insuline efsitora alpha administrée une fois par semaine, comparée à l'insuline degludec administrée une fois par jour chez des adultes atteints de diabète de type 2. L'étude, publiée dans le New England Journal of Medicine et présentée lors de l'EASD 2024, a montré que l'efsitora a atteint son objectif principal de réduction A1C non inférieure. Les principaux résultats incluent :
- L'efsitora a réduit l'A1C de 1,34 % contre 1,26 % pour l'insuline degludec
- Les participants ont atteint 45 minutes de plus de temps dans la plage chaque jour avec l'efsitora
- Aucun événement hypoglycémique sévère n'a été rapporté avec l'efsitora
- L'efsitora a démontré un profil de sécurité similaire à celui des insulines quotidiennes
Ces résultats suggèrent que l'efsitora pourrait offrir une option pratique d'administration hebdomadaire pour les patients diabétiques de type 2, améliorant potentiellement l'adhésion au traitement tout en fournissant des résultats comparables à ceux des insulines quotidiennes.
Eli Lilly and Company (NYSE: LLY) hat vielversprechende Ergebnisse aus der QWINT-2 Phase-3-Studie zur wöchentlichen Insulin efsitora alfa im Vergleich zu täglichem Insulin degludec bei Erwachsenen mit Typ-2-Diabetes bekannt gegeben. Die Studie, die im New England Journal of Medicine veröffentlicht und auf der EASD 2024 präsentiert wurde, zeigte, dass efsitora seinen primären Endpunkt der nicht unterlegenen A1C-Reduktion erreichte. Wichtige Ergebnisse umfassen:
- Efsitora reduzierte die A1C um 1,34 % im Vergleich zu 1,26 % für Insulin Degludec
- Teilnehmer erreichten 45 Minuten mehr Zeit im Zielbereich pro Tag mit efsitora
- Es wurden keine schweren hypoglykämischen Ereignisse mit efsitora berichtet
- Efsitora wies ein Sicherheitsprofil ähnlich wie tägliche Insuline auf
Diese Ergebnisse deuten darauf hin, dass efsitora eine bequeme wöchentliche Option für Patienten mit Typ-2-Diabetes bieten könnte, die möglicherweise die Therapietreue verbessert und vergleichbare Ergebnisse zu täglichen Insulinen liefert.
- Efsitora met the primary endpoint of non-inferior A1C reduction compared to insulin degludec
- Efsitora reduced A1C by 1.34% vs. 1.26% for insulin degludec
- Participants achieved 45 minutes more time in range per day with efsitora
- No severe hypoglycemic events were reported with efsitora compared to six with insulin degludec
- Efsitora demonstrated a safety profile similar to daily insulins
- None.
Insights
This study showcases efsitora's potential as a game-changer in diabetes management. The once-weekly dosing addresses a significant adherence barrier in insulin therapy. With an A1C reduction of
Eli Lilly's efsitora represents a significant innovation in the competitive insulin market. The positive QWINT-2 trial results position efsitora as a strong contender against established daily insulins. The once-weekly dosing is a clear differentiator, addressing the unmet need for reduced treatment burden. This could drive market share gains, especially among newly diagnosed patients or those struggling with daily regimens. The comparable efficacy to insulin degludec, a leading basal insulin, suggests efsitora could capture a substantial portion of the
Efsitora's development aligns with the growing focus on patient-centered care and treatment adherence in healthcare policy. The once-weekly dosing could significantly reduce the economic burden of diabetes by improving medication adherence, potentially leading to fewer hospitalizations and complications. This aligns with value-based care models, which emphasize outcomes over volume. However, policymakers and payers will closely scrutinize the cost-effectiveness of efsitora compared to existing daily insulins. The similar efficacy to insulin degludec may prompt discussions on pricing and access policies. If priced competitively, efsitora could become a preferred option in clinical guidelines, potentially influencing diabetes care standards globally.
In QWINT-2, efsitora helped adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists achieve an A1C below
Detailed results were published in The New England Journal of Medicine and simultaneously presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024
In the trial, efsitora met the primary endpoint of non-inferior A1C reduction. For the efficacy estimand1,2, efsitora reduced A1C by
Additionally, participants taking efsitora achieved 45 minutes more time in range4 per day, a key secondary endpoint, without additional time in hypoglycemia (glucose <54 mg/dL) in comparison to insulin degludec for the efficacy estimand.
"Traditionally, basal insulins are dosed once a day — a treatment schedule that can make compliance difficult for a significant portion of people living with type 2 diabetes," said Carol Wysham, M.D., clinical professor of medicine at the University of Washington School of Medicine. "Efsitora has the potential to address treatment burden and improve adherence — all while lowering A1C. These results can make a significant impact for people living with type 2 diabetes looking for a once-weekly option that provides similar outcomes as daily insulins."
Full Results
QWINT-2 Study: Primary and Secondary Endpoints | ||
Efficacy Estimand | Treatment-Regimen Estimand5 | |
Primary Endpoint – A1C Reduction (Resulting A1C) at Week 52 | ||
Efsitora | - | - |
Degludec | - | - |
Secondary Endpoint – A1C Reduction in Participants using GLP-1s (Resulting A1C) at Week 52 | ||
Efsitora | - | - |
Degludec | - | - |
Secondary Endpoint – A1C Reduction in Participants not using GLP-1s (Resulting A1C) at Week 52 | ||
Efsitora | - | - |
Degludec | - | - |
Secondary Endpoint – Percent Time in Range During the 4 Weeks Prior to Week 52 | ||
Efsitora | 68.86 % | 64.27 % |
Degludec | 65.75 % | 61.18 % |
"For the past century, we've been searching for the next scientific breakthrough that would alleviate the complexity that comes with starting insulin treatment," said Jeff Emmick, M.D., Ph.D., senior vice president, product development, Lilly. "With these results, we believe we're headed towards a future where people with type 2 diabetes who use basal insulin can achieve their desired results with a simple treatment option like efsitora."
In the trial, efsitora demonstrated a safety profile similar to daily insulins. There were no severe hypoglycemic events reported during treatment with efsitora compared to six reported with insulin degludec. Overall hypoglycemia rates in the study were low, with estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL) hypoglycemic events per patient-year of exposure of 0.58 with efsitora vs. 0.45 with insulin degludec. Estimated combined rates of severe or clinically significant nocturnal hypoglycemic events per patient-year of exposure were 0.08 with both efsitora and insulin degludec. Additionally, rates of hypoglycemia were similar among people currently using GLP-1s and those not using GLP-1s. Adverse events were similar between treatment groups in the trial.
Detailed results for QWINT-5 are also being presented at EASD and simultaneously published in The Lancet.
About the QWINT clinical trial program
The QWINT phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 4,000 people living with type 1 or type 2 diabetes across five global registration studies.
QWINT-2 (NCT05362058) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 928 participants across the
About insulin efsitora alfa
Insulin efsitora alfa (efsitora) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in phase 3 development for adults with type 1 and 2 diabetes.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including statements about insulin efsitora alfa as a potential treatment for people with type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to insulin efsitora alfa and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that insulin efsitora alfa will prove to be a safe and effective treatment for type 2 diabetes, that insulin efsitora alfa will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
1 The efficacy estimand represents the treatment effect had all participants adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia.
2
3 From a baseline A1C of
4 Blood glucose 70-180 mg/dL.
5 Treatment-regimen estimand represents the efficacy irrespective of adherence to the investigational medicine or introduction of rescue therapy for persistent severe hyperglycemia.
6 From a baseline A1C of
7
Refer to: | Niki Smithers; smithers_niki@lilly.com, 317-358-9074 (Media) |
Joe Fletcher; jfletcher@lilly.com, 317-296-2884 (Investors) |
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