A Multi-centre, Prospective, Open Label, Non-interventional, Single-armed, 52 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Awiqli Once Weekly in Patients With Diabetes Mellitus Under Real-world Clinical Practice Setting in Japan

The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.

开始日期2025-04-15

申办/合作机构

Novo Nordisk A/S

NCT06340854

/ Completed临床3期

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

开始日期2024-04-19

申办/合作机构

Novo Nordisk A/S

NCT06288412

/ Completed临床1期

Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

开始日期2024-02-26

申办/合作机构

Novo Nordisk A/S

100 项与依柯胰岛素相关的临床结果

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100 项与依柯胰岛素相关的转化医学

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100 项与依柯胰岛素相关的专利（医药）

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103

项与依柯胰岛素相关的文献（医药）

2025-07-01·Lancet Diabetes & Endocrinology

Once‑weekly IcoSema versus once‑weekly insulin icodec in type 2 diabetes management (COMBINE 1): an open‑label, multicentre, treat‑to‑target, randomised, phase 3a trial

Article

作者: Terauchi, Yasuo ; Mathieu, Chantal ; Pagliaro Rocha, Thaís M ; Ramachandran, Ambady ; Ji, Linong ; Shankarappa, Vinay Babu ; Larsen, Jonas Hughes ; Giorgino, Francesco ; Kim, Sin Gon ; Philis-Tsimikas, Athena

BACKGROUND:

IcoSema is a once‑weekly combination therapy of basal insulin icodec (icodec) and semaglutide (a GLP‑1 analogue) currently in development. COMBINE 1 compared the efficacy and safety of IcoSema with once‑weekly icodec alone in adults with inadequately controlled type 2 diabetes on daily basal insulin therapy.

METHODS:

COMBINE 1, a 52‑week, open‑label, treat‑to‑target, randomised, phase 3a trial, was done at 192 outpatient clinics and hospital departments across 20 countries and regions. Individuals aged 18 years or older with a BMI of 40 kg/m² or less and type 2 diabetes (HbA_1c 7·0-10·0% [53·0-85·8 mmol/mol]) treated with daily basal insulin with or without oral glucose‑lowering medications were randomly assigned (1:1) via a randomisation and trial supply management system to IcoSema (700 U/mL plus 2 mg/mL) or icodec (700 U/mL), both administered as subcutaneous injections on the same day each week, at any time of the day. There was no stratification based on participants' baseline characteristics. The primary endpoint was change in HbA_1c from baseline to week 52, evaluated in the full analysis set (all randomly assigned participants). The trial is registered with ClinicalTrials.gov, NCT05352815, and has been completed.

FINDINGS:

Between June 1, 2022, and March 13, 2023, 1671 individuals were screened, of whom 1291 (mean age 60·6 years [SD 10·3]; 799 [62%] males and 492 [38%] females) were randomly assigned to IcoSema (n=646) or icodec (n=645). At week 52, from a baseline value of 8·22% (SD 0·83; 66·3 mmol/mol [9·1]), estimated mean change in HbA_1c was -1·55 percentage points (SE 0·03; -16·9 mmol/mol [0·4]) with IcoSema and -0·89 percentage points (SE 0·03]; -9·7 mmol/mol [0·4]) with icodec (estimated treatment difference [ETD] -0·66 percentages points [95% CI -0·76 to -0·57]; -7·3 mmol/mol [-8·3 to -6·2]; p<0·0001; superiority confirmed). The rate of combined clinically significant or severe hypoglycaemia from baseline to week 57 was significantly lower with IcoSema than with icodec (0·14 vs 0·63 episodes per person‑year of exposure; estimated rate ratio 0·22 [95% CI 0·14 to 0·36]; p<0·0001; superiority confirmed). The most frequently reported adverse events were within the system organ class of gastrointestinal disorders in the IcoSema group (303 [47%] of 644 participants had 1033 events during the trial) and infections and infestations in the icodec group (275 [43%] of 644 participants had 466 events. 59 (9%) participants in the IcoSema group and 69 (11%) participants in the icodec group had a serious adverse event. No treatment-related deaths occurred.

INTERPRETATION:

In adults with inadequately controlled type 2 diabetes on daily basal insulin therapy, once‑weekly IcoSema showed superiority to once-weekly icodec alone in changes in HbA_1c and in overall lower rate of combined clinically significant or severe hypoglycaemia. IcoSema might provide an option for insulin therapy intensification in adults with type 2 diabetes.

FUNDING:

Novo Nordisk.

TRANSLATIONS:

For the Chinese and Japanese translations of the abstract see Supplementary Materials section.

2025-07-01·DIABETOLOGIA

The effect of once-weekly insulin icodec vs once-daily basal insulin on physical activity-attributed hypoglycaemia in type 2 diabetes: a post hoc analysis of ONWARDS 1–5

Article

作者: Heller, Simon ; Woo, Vincent C ; Riddell, Michael C ; Kehlet Watt, Sara ; Carstensen, Lisbeth ; Rocha, Thaís M Pagliaro

Abstract:

Aims/hypothesis:

Physical activity increases the risk of hypoglycaemia in individuals with type 2 diabetes when basal or basal-bolus insulin therapy is administered. Once-weekly basal insulins may elevate the risk of physical activity-attributed hypoglycaemia compared with other basal insulins because the administered levels cannot be reduced in anticipation of increased physical activity. This post hoc analysis of five separate randomised trials (ONWARDS 1–5) aimed to examine physical activity-attributed hypoglycaemic episodes in adults with type 2 diabetes receiving either once-weekly basal insulin icodec (herein referred to as ‘icodec’) or once-daily basal insulins.

Methods:

The ONWARDS 1–5 Phase 3a randomised controlled trials compared the efficacy and safety of once-weekly basal icodec vs once-daily basal insulin in insulin-naive (ONWARDS 1, 3 and 5) and insulin-experienced (ONWARDS 2 and 4) adults with type 2 diabetes. Participants self-monitored their blood glucose levels using a blood glucose meter and a digital diary. In each trial, suspected hypoglycaemia symptoms triggered additional self-measured blood glucose readings, and values indicative of hypoglycaemia were recorded in the participants’ digital diary. Participants who experienced hypoglycaemic episodes were instructed to note any relation of each episode to physical activity. Hypoglycaemic episodes were classified as alert value (level 1: blood glucose <3.9 but ≥3.0 mmol/l), clinically significant (level 2: blood glucose <3.0 mmol/l) or severe (level 3: cognitive impairment requiring external assistance). The proportions of hypoglycaemic episodes that were attributed to physical activity and the ORs of having a physical activity-attributed hypoglycaemic episode were calculated for the two basal insulin types (once-weekly vs once-daily) for each of the five trials.

Results:

Across all trials, there were no consistent differences between icodec and the once-daily insulin comparators in the proportions of hypoglycaemic episodes that were attributed to physical activity; these episodes were mainly alert value or clinically significant hypoglycaemic episodes. In both insulin-naive and insulin-experienced participants, the incidence of physical activity-attributed clinically significant or severe hypoglycaemic episodes was consistently ≤3.0% in ONWARDS 1, 2, 3 and 5. In ONWARDS 4, the incidence of physical activity-attributed hypoglycaemic episodes was numerically higher in both treatment groups (18.6% [icodec] vs 17.9% [insulin glargine U100]), which was expected given the basal-bolus insulin regimen. Across all trials, there were no statistically significant differences in the odds of experiencing a physical activity-attributed clinically significant or severe hypoglycaemic episode with icodec vs once-daily insulin comparators. The frequency of recurrent clinically significant or severe hypoglycaemic episodes in the 24 h after a physical activity-attributed clinically significant or severe hypoglycaemic episode was low, with no such episodes in ONWARDS 1, 3 and 5. In contrast, in ONWARDS 2 and 4, the frequency of recurrent clinically significant hypoglycaemic episodes in the 24 h after a physical activity-attributed clinically significant or severe hypoglycaemic episode was numerically higher with icodec vs the once-daily insulin comparators, whilst no additional severe episodes were reported in any participants across the trials.

Conclusions/interpretation:

These findings do not suggest that there is an additional increase in hypoglycaemia risk attributed to physical activity with once-weekly basal icodec vs once-daily basal insulins in adults with type 2 diabetes.

Trial registration:

ClinicalTrials.gov NCT04460885 (ONWARDS 1), NCT04770532 (ONWARDS 2), NCT04795531 (ONWARDS 3), NCT04880850 (ONWARDS 4) and NCT04760626 (ONWARDS 5).

Graphical Abstract:

2025-06-01·ANNALS OF PHARMACOTHERAPY

Icodec: A Novel Once-Weekly Basal Insulin for Diabetes Management

Review

作者: Isaacs, Diana ; Goldman, Jennifer ; Triplitt, Curtis

Objective::

To evaluate the efficacy, safety, and clinical implications of insulin icodec, a novel once-weekly basal insulin for the treatment of type 1 diabetes (T1D) and type 2 diabetes (T2D), with an emphasis on its advantages and challenges in comparison with existing daily basal insulins.

Data Sources::

A literature search was performed using PubMed, Google Scholar, Embase, and ClinicalTrials.gov up to August 26, 2024, using the search terms icodec and ONWARDS trial . Studies involving patients living with T1D or T2D on once-weekly insulin icodec compared with once-daily insulins glargine U100, glargine U300, and degludec were considered for this review.

Study Selection and Data Extraction::

Relevant English-language studies and those conducted in humans were considered.

Data Synthesis::

Insulin icodec offers reduced dosing frequency and potentially superior glycemic management with a safety profile comparable to existing basal insulins.

Relevance to Patient Care and Clinical Practice::

Insulin icodec once-weekly dosing could significantly improve convenience and efficacy over daily basal insulins, representing a significant innovation in insulin therapy.

Conclusions::

Insulin icodec emerges as a promising option for diabetes management, potentially improving treatment adherence and quality of life.

197

项与依柯胰岛素相关的新闻（医药）

2025-06-27

·国际糖尿病idiabetes

ADA 2025胰岛素周制剂依柯胰岛素最新证据——不同基线HbA1c、病程和BMI的T2DM患者应用依柯胰岛素确证其疗效和安全性

全球首个胰岛素周制剂依柯胰岛素已进入临床实践，成为2型糖尿病（T2DM）血糖管理的新利器。面对临床特征多样化的T2DM人群，依柯胰岛素能否满足“以患者为中心”的个体化治疗需求？第85届美国糖尿病协会科学年会（ADA 2025）会议公布了多项ONWARDS研究事后亚组分析，为评估在不同基线糖化血红蛋白（HbA1c）、糖尿病病程、体重指数（BMI）T2DM患者中，依柯胰岛素应用的有效性和安全性提供了新证据。本刊摘取重要内容，并特邀中山大学附属第一医院李延兵教授进行点评。依柯胰岛素在T2DM患者中进行了5项3a期临床研究（ONWARDS 1~5），共纳入3765例广泛临床特征的成人T2DM患者。结果证实，在既往未使用胰岛素治疗（ONWARDS 1、3、5）或已使用胰岛素治疗（ONWARDS 2、4）的T2DM患者中，与基础胰岛素日制剂相比，依柯胰岛素的HbA1c降幅显著更优或相似，更多患者实现HbA1c安全达标，低血糖发生率相似[1-5]。既往已公布的亚组分析显示，依柯胰岛素疗效和安全性不受年龄、肾功能、种族等因素影响[6-8]。本次ADA会议公布了更多新数据，聚焦基线HbA1c、T2DM病程、BMI亚组，进一步丰富了依柯胰岛素在不同临床特征T2DM人群中有效性和安全性的证据。822-P根据基线HbA1c分层分析：依柯胰岛素相较基础胰岛素日制剂的疗效和安全性一致该事后分析将ONWARDS 1~5研究患者依照基线HbA1c分为≤8%、>8%~≤9%、>9%三个亚组，评估不同HbA1c的T2DM患者应用依柯胰岛素相较于基础胰岛素日制剂的疗效和安全性[9]。结果显示，总体而言，在所有研究的各HbA1c亚组中，依柯胰岛素组均较对照组呈现数值上更大的HbA1c降幅，除ONWARDS 4（基础-餐时胰岛素试验）中的HbA1c>8%~≤9%和>9%亚组外。各研究中，HbA1c从基线至治疗结束的降幅均未观察到治疗与HbA1c亚组之间存在有统计学显著性的交互作用（图1）。无论基线HbA1c如何，依柯胰岛素组与对照组有临床意义的低血糖或严重低血糖（2级或3级低血糖）的发生率均较低（<1事件/患者暴露年），仅ONWARDS 4各亚组中两个治疗组的低血糖发生率在数值上较高。各研究中，在治疗结束时达到HbA1c<7%且过去12周无2级或3级低血糖的复合终点方面，均未发现具有统计学意义的治疗与HbA1c亚组交互作用。该分析证实，在各基线HbA1c亚组中，依柯胰岛素相较基础胰岛素日制剂的疗效和低血糖结局总体相似。图1. ONWARDS 1~5中按基线HbA1c分层的HbA1c估计治疗差异816-P根据糖尿病病程分层分析：依柯胰岛素相较基础胰岛素日制剂的疗效和安全性一致该事后分析将ONWARDS 1~5研究患者依照基线糖尿病病程分为<5年、5~<10年、10~<15年、≥15年四个亚组，评估不同糖尿病病程T2DM患者应用依柯胰岛素相较于基础胰岛素日制剂的疗效和安全性[10]。结果显示，总体而言，在所有研究的各T2DM病程亚组中，依柯胰岛素组均较对照组呈现数值上更大的HbA1c降幅，除ONWARDS 3和4中的部分亚组外。各研究中，HbA1c从基线至治疗结束的降幅均未观察到治疗与病程亚组之间存在有统计学显著性的交互作用（图2）。依柯胰岛素与对照组2级或3级低血糖的发生率均较低，仅ONWARDS 4各亚组中两个治疗组的低血糖发生率在数值上较高。各研究中，在治疗结束时达到HbA1c<7%且过去12周无2级或3级低血糖的复合终点方面，均未发现具有统计学意义的治疗与T2DM病程亚组交互作用。该分析证实，在各T2DM病程亚组中，依柯胰岛素相较基础胰岛素日制剂的疗效和低血糖结局总体相似。图2. ONWARDS 1~5中按基线糖尿病病程分层的HbA1c估计治疗差异819-P根据基线BMI分层分析：依柯胰岛素相较基础胰岛素日制剂的疗效和安全性一致该事后分析将ONWARDS 1~5研究患者依照基线BMI分为<25 kg/m2、≥25~<30 kg/m2、≥30~<35 kg/m2、≥35 kg/m2四个亚组，评估不同BMI的T2DM患者应用依柯胰岛素相较于基础胰岛素日制剂的疗效和安全性[11]。结果显示，总体而言，在所有研究的各BMI亚组中，依柯胰岛素组均较对照组呈现数值上更大的HbA1c降幅，除ONWARDS 4（基础-餐时胰岛素试验）中的部分亚组外。各研究中，HbA1c从基线至治疗结束的降幅均未观察到治疗与BMI亚组之间存在有统计学显著性的交互作用（图3）。除ONWARDS 4研究外，无论基线BMI如何，依柯胰岛素与对照组2级或3级低血糖的发生率均较低，ONWARDS 4研究各亚组中两个治疗组间低血糖发生率总体相似。各研究中，在治疗结束时达到HbA1c<7%且过去12周无2级或3级低血糖的复合终点方面，均未发现具有统计学意义的治疗与BMI亚组交互作用。该分析证实，在各基线BMI亚组中，依柯胰岛素相较基础胰岛素日制剂的疗效和低血糖结局总体相似。图3. ONWARDS 1~5中按基线BMI分层的HbA1c估计治疗差异专家点评李延兵教授中山大学附属第一医院在临床实践中，T2DM患者特征及临床情况复杂多样，同一种药物治疗在不同特征的患者人群中可能会展现出不一致的疗效和安全性，这就体现出个体化治疗的重要性。目前，T2DM管理新理念强调“以患者为中心”，胰岛素个体化治疗应基于对患者特征和临床因素的综合评估，以实现优化血糖控制。依柯胰岛素作为首个胰岛素周制剂，显著减轻注射负担，助力提高胰岛素治疗的依从性和持续性，提高患者生活质量。在重塑胰岛素治疗新模式的同时，胰岛素周制剂的个体化治疗也备受临床关注，其能否应对各种临床实践状况，满足多样化人群的治疗需求呢？目前，依柯胰岛素已在不同人口学和疾病特征的T2DM人群中积累了较多相关证据，主要源自ONWARDS 1~5研究事后分析。综合既往公布以及本次ADA新报道的亚组分析，总体来说，在既往未使用胰岛素或已使用胰岛素治疗的T2DM患者中，依柯胰岛素相较基础胰岛素日制剂的降糖疗效和安全性不受年龄、肾功能、种族、基线HbA1c、T2DM病程以及BMI等因素的影响。这些证据支持，依柯胰岛素治疗可为不同临床特征的广泛T2DM患者带来一致获益，满足个体化治疗需求。期待今后能积累更多研究证据和实践经验，细化并优化治疗时机和人群，使得这种创新性基础胰岛素周制剂能更好地造福糖尿病患者。参考文献（上下滑动可查看）1. Rosenstock J, et al. N Engl J Med. 2023; 389(4): 297-308. ONWARDS 12. Lingvay I, et al. JAMA. 2023; 330(3): 228-237. ONWARDS 33. Bajaj HS, et al. Ann Intern Med. 2023; 176(11): 1476-1485. ONWARDS 54. Philis-Tsimikas A, et al. Lancet Diabetes Endocrinol. 2023; 11(6): 414-425. ONWARDS 25. Mathieu C, et al. Lancet. 2023; 401(10392): 1929-1940. ONWARDS 46. Andre GD Vianna, et al. Impact of Age on the Efficacy and Safety of Once-Weekly Insulin Icodec vs. Once-Daily Insulin in Type 2 Diabetes (ONWARDS 1–5). Presented at ADA 2024 meeting. 838-P.7. Peter Rossing, et al. Efficacy and Safety of Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in Individuals with Type 2 Diabetes by Kidney Function—ONWARDS 1–5. Presented at ADA 2024 meeting. 826-P.8. Ildiko Lingvay, et al. Efficacy and Safety of Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in Type 2 Diabetes by Ethnicity and Race—ONWARDS 1–5. Presented at ADA 2024 meeting. 841-P.9. CHANTAL MATHIEU, et al. Efficacy and Hypoglycemia Outcomes with Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in T2D by Baseline A1C—ONWARDS 1–5. Presented at ADA 2025 meeting. 822-P.10. ALICE Y.Y. CHENG, et al. Efficacy and Hypoglycemia Outcomes with Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in T2D by Diabetes Duration—ONWARDS 1–5. Presented at ADA 2025 meeting. 816-P.11. LUIS HENRIQUE S.S. CANANI, et al. Efficacy and Hypoglycemia Outcomes with Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in T2D by Baseline BMI—ONWARDS 1–5. Presented at ADA 2025 meeting. 819-P.声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

临床结果临床2期

2025-06-23

·FiercePharma

Lilly eyes global approval filings as once-weekly insulin candidate takes clinical victory lap

Eli Lilly says it plans to take its efsitora data package to global regulatory agencies by the end of this year. With detailed readouts from a suite of late-stage trials now on tap, Eli Lilly is heading to regulators in pursuit of a green light for its once-a-week insulin asset efsitora alfa.Lilly on Sunday provided a comprehensive look at positive results from its QWINT-1, QWINT-3 and QWINT-4 studies, which assessed efsitora in Type 2 diabetes patients using insulin for the first time, those who previously used daily basal insulin and those who previously used daily basal insulin and mealtime insulin, respectively.Efsitora—which would allow diabetes patients to cut back on more than 300 insulin injections per year if approved—helped patients achieve noninferior A1C (blood sugar) reduction versus daily basal insulin in all three studies, helping the clutch of trials meet their primary endpoints, Lilly said.With those winning results in hand, Lilly says it plans to take its efsitora data package to global regulatory agencies by the end of this year. Overall, Lilly has unveiled positive readouts from five different trials in the QWINT program, which kicked off in 2022.The momentum behind efsitora comes as Lilly’s chief metabolic medicine rival Novo Nordisk has struggled to win clearance for its own once-weekly insulin in the U.S. That said, Novo’s drug, known commercially as Awiqli, already boasts approvals in territories like Europe, Canada, Japan and Australia. Breaking down the results, efsitora helped reduce patients’ A1C by 1.31% versus 1.27% for insulin glargine at the QWINT-1 study’s 52-week mark. In QWINT-3, efsitora reduced A1C by 0.86% at Week 26 and in QWINT-4 by 1.07% over the same time frame, compared to 0.75% for insulin degludec and 1.07% for insulin glargine, respectively.Lilly also unveiled results from several key secondary endpoints in QWINT-3 and 4. In the former trial, efsitora patients’ glucose levels were in range 62.8% of the time during the four weeks leading up to Week 26 of the study, compared to 61.3% of the time for those on insulin degludec.In QWINT-4, meanwhile, efsitora helped 39.5% of patients achieve an A1C less than 7% at Week 26 without nocturnal hypoglycemia, compared to 36.6% of patients receiving insulin glargine.For QWINT-1, Lilly says it titrated efsitora to four fixed doses at four-week intervals, as needed for blood glucose control. In QWINT-3 and 4, efsitora was given via traditional insulin dosing with adjustments according to each patient’s glucose level, the company explained.Efsitora’s safety in the three studies was on par with insulin glargine and insulin degludec, which are among the most commonly used daily basal insulins, Lilly noted in its release.In the QWINT-1 study, patients on efsitora experienced roughly 40% fewer hypoglycemic events—when a person’s blood sugar drops too low—compared to insulin glargine, Lilly pointed out.Meanwhile, at the QWINT-1 study’s 52-week mark, the estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure was 0.50 with efsitora versus 0.88 with insulin glargine. For QWINT-3, those results clocked in at 0.84 with efsitora versus 0.74 with insulin degludec at 78 weeks, while the QWINT-4 results came in at 6.6 with efsitora versus 5.9 with insulin glargine at 26 weeks."Building on Lilly's legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," Jeff Emmick, M.D., Ph.D., Lilly’s senior vice president of product development, said in a statement. "These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach”Across the QWINT program, Lilly has looked at efsitora’s performance in more than 3,000 Type 2 diabetes patients. QWINT-1 enrolled 795 participants versus 986 for QWINT-3 and 730 for QWINT-4.Lilly presented the latest trio of readouts over the weekend at the 85th American Diabetes Association Scientific Sessions in Chicago. The results from QWINT-1 were also published in The New England Journal of Medicine, while data from QWINT-3 and 4 have made their way into The Lancet, according to Lilly.The detailed look at QWINT-1, 3 and 4 follows a succession of positive readouts from the program since last May, when Lilly first revealed that the QWINT-2 and 4 studies had met their A1C noninferiority endpoints. QWINT-2 was specifically designed to assess whether the use of GLP-1 medicines for diabetes like Mounjaro or Novo’s Ozempic could weigh on efsitora’s efficacy.Lilly is betting big on efsitora’s potential to both improve treatment for patients already using daily insulin and encourage new patients to start using the medication.“Imagine 313 fewer injections per year,” Paul Owens, VP of global brand development for insulins and glucagon at Lilly, said of the drug’s promise in an interview with Fierce Biotech last year. “We believe it has the potential to really improve adherence … and for some, the innovation of a simple, once-weekly approach to dosing could really mean the difference between starting the treatment and not.”Diabetes patients have been grappling with daily insulin dosing for nearly a century, and those repetitive injections in response to blood glucose tests can become a “huge burden” for people living with the disease, Owens said at the time.Though Novo Nordisk beat Lilly to the punch launching its weekly insulin product Awiqli overseas, Lilly now appears poised to take the lead in the U.S. Last July, the FDA rejected Novo’s application for the product, which is also known as insulin icodec. Novo credited the rejection to “requests related to the manufacturing process and the type 1 diabetes indication.” At the time, Novo cautioned that it didn’t expect to resolve the issue by the end of 2024.The snub followed an unfavorable vote from an FDA advisory committee, which largely revolved around questions about icodec’s potential to cause low blood sugar.Ultimately, seven of 11 panelists agreed that the data Novo presented were not sufficient to conclude that the benefits of icodec outweighed the risks for adults with Type 1 diabetes.

临床结果

2025-06-23

·药事纵横

超长效胰岛素将进入双雄角逐的时代，礼来每周一次的efsitora非劣于每日一次的基础胰岛素

为了减少患者频繁打针的痛苦，胰岛素长效化是重要的研发趋势，而作为全世界胰岛素龙头企业的礼来公司，也开发了一种超长效胰岛素——Insulin efsitora alfa（efsitora），它是由新型单链胰岛素变体与人IgG2 Fc结构域组成的融合蛋白。早在2022年，礼来就启动了一项名为QWINT的大型三期临床研究，以评估efsitora的安全有效性。四项试验一共入组了3000多名二型糖尿病患者，并在所有试验中，每周一次的efsitora均达到了与每日基础胰岛素相比非劣效的糖化血红蛋白（A1C）降低这一主要终点。QWINT-1（NCT05662332）是一项平行设计、开放标签、达标治疗随机对照临床试验，比较了每周一次efsitora采用固定剂量递增方案与每日甘精胰岛素在胰岛素初治2型糖尿病成人患者中52周的疗效和安全性。该试验在美国、阿根廷和墨西哥随机分配795名受试者接受每周一次efsitora或每日一次甘精胰岛素皮下注射。efsitora组起始剂量为100单位胰岛素，随后根据需要每四周递增至150单位、250单位和400单位固定剂量，直至达到空腹血糖80-130 mg/dL目标。16周后空腹血糖>130 mg/dL的受试者转为灵活剂量。试验主要目的是证明efsitora在52周时降低A1C不劣于每日甘精胰岛素。QWINT-3（NCT05275400）是一项多中心随机平行开放标签试验，在目前接受基础胰岛素治疗的2型糖尿病成人患者中，比较了每周一次efsitora与德谷胰岛素在3周导入期后78周治疗及5周安全随访期的疗效和安全性。试验在美国、阿根廷、匈牙利、日本、韩国、波兰、波多黎各、斯洛伐克、西班牙和台湾地区随机分配986名受试者接受每周一次efsitora或每日一次德谷胰岛素皮下注射。主要目的是证明efsitora在26周时降低A1C不劣于德谷胰岛素。QWINT-4（NCT05462756）是一项平行设计、开放标签、达标治疗随机对照临床试验，在既往接受基础胰岛素和每日至少两次餐时胰岛素注射的2型糖尿病成人患者中，比较了每周一次efsitora与甘精胰岛素26周的疗效和安全性。试验在美国、阿根廷、德国、印度、意大利、墨西哥、波多黎各和西班牙随机分配730名受试者接受每周一次efsitora或每日一次甘精胰岛素（均与赖脯胰岛素联用）皮下注射。主要目的是证明efsitora在26周时降低A1C不劣于甘精胰岛素。在QWINT-1试验中，根据疗效估计值，efsitora在第52周使A1C降低1.31%，而甘精胰岛素组为1.27%。该试验中efsitora采用每四周调整一次的四个固定剂量方案，根据血糖控制需要进行滴定。在QWINT-3试验中，efsitora在第26周使A1C降低0.86%，德谷胰岛素组为0.75%。在QWINT-4试验中，efsitora与甘精胰岛素在第26周均使A1C降低1.07%。后两项试验中efsitora采用传统胰岛素剂量调整方法，根据患者个体血糖水平进行调节。三项试验中，efsitora总体安全性与两种最常用的2型糖尿病每日基础胰岛素治疗相当。在QWINT-1中，efsitora的低血糖事件发生率较甘精胰岛素低约40%，52周时严重或临床显著低血糖事件合计发生率为efsitora组每患者年0.50次 vs 甘精胰岛素组0.88次。在QWINT-3中，78周时efsitora组为0.84次 vs 德谷胰岛素组0.74次。在QWINT-4中，26周时efsitora组为6.6次 vs 甘精胰岛素组5.9次。除了礼来，诺和诺德也开发了每周一次的超长效胰岛素依柯胰岛素，而该产品是一种脂肪酸酰化胰岛素，目前已经获批上市。基于临床试验结果，礼来称将在年底提交NDA，如果不出意外，明年将进入每周一次的超长效胰岛素双雄角逐的时代。相比每日一次的基础胰岛素，每周一次的超长效产品，每年可减少300多次注射，对患者而言是巨大的福音。药事纵横投稿须知：稿费已上调，欢迎投稿

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100 项与依柯胰岛素相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
糖尿病	欧盟	Novo Nordisk A/S	2024-05-17
糖尿病	冰岛	Novo Nordisk A/S	2024-05-17
糖尿病	列支敦士登	Novo Nordisk A/S	2024-05-17
糖尿病	挪威	Novo Nordisk A/S	2024-05-17
1型糖尿病	加拿大	Novo Nordisk Canada, Inc.	2024-03-12
2型糖尿病	加拿大	Novo Nordisk Canada, Inc.	2024-03-12

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04460885 (ONWARDS 1, CTgov)	临床3期	2型糖尿病	984	Insulin icodec (Insulin Icodec)	餘觸獵壓鹽築廠鏇膚淵(鹽鹹鏇糧廠衊遞簾淵範) = 壓廠顧淵淵遞遞齋衊觸簾衊鏇觸憲網窪繭獵製 (廠憲積夢壓遞醖觸網餘, 0.06) 更多	-	2025-06-12
				Insulin glargine (Insulin Glargine)	餘觸獵壓鹽築廠鏇膚淵(鹽鹹鏇糧廠衊遞簾淵範) = 鏇繭衊鬱膚構積繭餘膚簾衊鏇觸憲網窪繭獵製 (廠憲積夢壓遞醖觸網餘, 0.05) 更多
NCT04848480 (ONWARDS 6, CTgov)	临床3期	1型糖尿病	582	insulin icodec+insulin aspart (Insulin Icodec + Insulin Aspart)	鹽淵齋獵構鹹衊糧襯蓋(衊製壓獵範艱艱蓋製鬱) = 窪淵築積網範鹽簾鏇醖鹽齋鑰鬱膚製鏇築獵膚 (選製遞餘簾鬱網網憲襯, 0.07) 更多	-	2025-06-12
				insulin degludec+insulin aspart (Insulin Degludec + Insulin Aspart)	鹽淵齋獵構鹹衊糧襯蓋(衊製壓獵範艱艱蓋製鬱) = 鑰衊鑰襯夢製憲廠簾餘鹽齋鑰鬱膚製鏇築獵膚 (選製遞餘簾鬱網網憲襯, 0.06) 更多
ONWARDS 1-6 (Pubmed \| Diabetes Ther)	临床3期	-	-	Icodec	衊齋網膚鬱遞鬱壓願糧(憲夢遞襯築繭醖築簾壓) = Mean HbA1c levels remained relatively stable over assessed time points for both treatment groups 鏇鹽壓夢觸築選築憲構 (衊窪繭夢膚鑰艱醖憲鹽 ) 更多	积极	2025-06-04
				Once-daily comparators (insulin degludec, insulin glargine U100, insulin glargine U300)
NCT05823948 (ONWARDS 9, Pubmed \| Diabetes Technol Ther) 人工标引	临床3期	2型糖尿病	51	Once-weekly Insulin Icodec	構選選壓糧遞壓壓積鑰(積鹹憲夢獵鬱範願選簾) = 顧淵鑰繭糧膚鹹餘鬱襯繭繭齋膚獵獵選蓋遞衊 (窪築襯鹹餘鬱糧夢齋壓, -1.36 ~ -0.99)	积极	2025-03-05
NCT04795531 (ONWARDS 3, Pubmed \| Diabetes Ther)	临床3期	2型糖尿病	-	Once-Weekly Insulin Icodec	膚蓋遞構夢範壓衊繭遞(積蓋遞選繭鏇觸糧糧觸): P-Value = 0.0152	积极	2025-02-28
				Once-Daily Insulin Degludec
NCT04770532 (ONWARDS 2, CTgov)	临床3期	2型糖尿病	526	Insulin Icodec (Insulin Icodec)	壓鬱廠壓獵獵艱簾齋顧(簾積衊築鹽獵選襯鬱廠) = 衊網窪壓襯衊淵鏇選窪壓築遞膚廠選顧窪淵壓 (襯壓餘製鹹醖鹽遞鬱窪, 0.05) 更多	-	2025-02-20
				Insulin Degludec (Insulin Degludec)	壓鬱廠壓獵獵艱簾齋顧(簾積衊築鹽獵選襯鬱廠) = 糧鹹簾願淵廠製醖簾衊壓築遞膚廠選顧窪淵壓 (襯壓餘製鹹醖鹽遞鬱窪, 0.06) 更多
NCT04795531 (ONWARDS 3, CTgov)	临床3期	2型糖尿病	588	placebo+insulin icodec (Insulin Icodec)	鹹鑰襯選構鏇鹹遞廠醖(糧遞窪壓餘願蓋淵簾構) = 齋範積簾壓顧醖觸網淵壓選鏇築築願鑰憲壓廠 (鹹積簾製餘構襯鹹鑰鑰, 0.05) 更多	-	2024-12-04
				Insulin Degludec (Insulin Degludec)	鹹鑰襯選構鏇鹹遞廠醖(糧遞窪壓餘願蓋淵簾構) = 製範鏇繭簾壓衊鹽選齋壓選鏇築築願鑰憲壓廠 (鹹積簾製餘構襯鹹鑰鑰, 0.05) 更多
PROSPERO CRD42023452468 (ENDO2024)	N/A	2型糖尿病	-	Insulin Icodec	夢簾窪顧餘廠餘積簾夢(艱積鑰廠夢鹽製襯壓齋) = 鏇艱壓繭淵鹹繭鏇遞醖鑰艱網積觸襯餘壓網築 (餘製艱鏇蓋齋鹹鏇願構, 0.42 ~ 1.15) 更多	积极	2024-06-01
NCT04880850 \| NCT04770532 (ONWARDS 4 \| ONWARDS 2, EASD2023)	临床3期	2型糖尿病	-	Once-weekly icodec	蓋獵築鬱構鹹窪積鑰憲(遞廠選蓋醖齋壓鹽願艱) = 鬱糧膚憲築膚觸構廠廠鏇蓋鬱顧鹽觸憲繭衊夢 (憲蓋醖鑰鹹鏇鏇鹽衊鹹 )	积极	2023-10-04
				Once-daily degludec	蓋獵築鬱構鹹窪積鑰憲(遞廠選蓋醖齋壓鹽願艱) = 淵夢醖艱淵壓鏇鏇觸繭鏇蓋鬱顧鹽觸憲繭衊夢 (憲蓋醖鑰鹹鏇鏇鹽衊鹹 )
NCT04760626 (ONWARDS 5, EASD2023)	临床3期	2型糖尿病	-	Once-weekly insulin icodec with a dosing guide app	衊夢糧壓鬱構觸醖網獵(簾糧製網糧鏇醖鹹繭繭): P-Value = <0.0001 更多	积极	2023-10-03
				Once-daily basal insulin analogues (degludec, glargine U100 or glargine U300)