A 26- Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess The Safety of Lyumjev in Adult Patients With Type 2 Diabetes Mellitus in India

The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.
The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).

开始日期2024-04-18

申办/合作机构

Eli Lilly & Co.

[+1]

NCT06717191

/ Completed临床4期IIT

Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth With Diabetes in Pakistan

This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Pakistan

开始日期2022-06-09

申办/合作机构-

NCT06674135

/ Completed临床4期IIT

Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh

开始日期2022-06-01

申办/合作机构

Bangladesh Institute of Research and Rehabilitation for Diabetes Endocrine and Metabolic Disorders

[+1]

100 项与甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的临床结果

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100 项与甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的转化医学

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项与甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的文献（医药）

2025-07-01·DIABETES OBESITY & METABOLISM

What do the guidelines say about use of biosimilar insulin therapy? Simple practical considerations to guide clinicians in different patient subgroups—Sharing Canadian perspectives

Review

作者: Chu, L. ; Abitbol, A.

Abstract:

Background:

The rising cost of insulins are significantly impacting health care expenditure, thereby limiting access to treatment for more people affected by diabetes. Fear and misunderstanding of insulin therapy have worsened with the emergence of biosimilar insulins. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference.

Results:

There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty ™. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins.

Conclusion:

Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. Tailoring effective conversations to patient needs ensures the best possible therapeutic outcomes.

Plain Language Summary:

This review article intends to review the efficacy and safety data from pivotal clinical trials with biosimilar insulins, as well as the regulatory and health economic considerations which underpin the safe and cost‐effective use of biosimilar insulin therapy. Biosimilars are not the same as generic medications. Generic medication contains identical ingredients to the reference, whereas biosimilar medication is highly comparable but not necessarily identical to the reference. There are five biosimilar insulins currently available in Canada: insulin glargine (U‐100) as the biosimilar insulins, Basaglar® and Semglee®, insulin lispro (U‐100) as the biosimilar insulin, Admelog® and insulin aspart (U‐100) as the biosimilar insulins, Trurapi® and Kirsty™. Data for biosimilars must be submitted in a stepwise approach to demonstrate similarity to the reference biologic under the following categories: structure & function, human clinical trials, comparative studies evaluating efficacy and safety and manufacturing quality control. Recent clinical trials have demonstrated comparable efficacy, safety and immunogenicity for biosimilar insulins compared with reference insulins. The dosing of biosimilar insulins is also the same as the reference for initiating, switching (1:1) and titrating. Health care providers are encouraged to stay up to date on the latest guidelines and recommendations regarding biosimilar insulin interchangeability to ensure safe and cost‐effective use of these products. Regulatory agencies, payors and clinical practice guideline committees are initiating biosimilar initiatives aimed at reducing costs, impacting more patients worldwide. While few studies have evaluated biosimilar insulin use in a real‐world clinical practice setting, the descriptive patterns retrieved from the LMC Diabetes Registry reflect the Ontario Ministry of Health's changes in biologic drug policy that were implemented to promote the use of biosimilar insulins. A summary of adults with diabetes from this registry showed 3.8% of individuals with T1D were prescribed Basaglar® before April 2023 compared to 12.0% after January 2024. For the T2D cohort, the use of basal biosimilar insulins, Basaglar® and Semglee®, similarly increased by approximately 10% and 2% after January 2024, respectively. The use of bolus biosimilar insulins also increased after January 2024 by approximately 28% in the T1D cohort and 60% in the T2D cohort using insulin therapy. Many health care providers are largely unfamiliar with biosimilar insulins. This limits the acceptance of biosimilar insulins by patients, as it is related to the comfort of health care providers in educating patients. People living with diabetes must have access to safe and effective treatment options, and they should be able to obtain appropriate medications at an affordable price and in a fair and timely manner.

2025-02-01·The Journal of the Association of Physicians of India

Safety and Efficacy of Biosimilar Insulin Glargine (Basaglar) in Indian Patients with Type 2 Diabetes Mellitus: Results from a Multicenter, Open-Label, Single-Arm, Phase 4 Trial (ABEX)

Article

作者: Arora, Rohit ; Bhattacharya, Indranil ; Shah, Parag ; Shamanna, Paramesh ; Spaepen, Erik ; Brahme, Keyur ; Saboo, Banshi ; Desai, Piyush ; Khandelwal, Deepak

BACKGROUND:

Basaglar^®, a biosimilar of glargine, was approved in India for the treatment of diabetes in patients aged >2 years. The efficacy and safety of biosimilar insulin glargine (Basaglar) have been previously established in Phase 3 clinical trials, ELEMENT-1, -2, and -5. This study assessed the safety and efficacy of Basaglar in Indian patients with type 2 diabetes mellitus (T2DM).

MATERIALS AND METHODS:

This multicenter, open-label, single-arm, phase 4 trial included Indian patients with insulin-naïve T2DM with glycated hemoglobin A1c (HbA1c) ≥7.0 to <11.0% who were receiving ≥2 oral antihyperglycemic drugs and/or a glucagon-like peptide-1-receptor agonist. Patients received Basaglar once daily for 24 weeks, excluding 4 weeks of safety follow-up. The primary endpoint was the incidence of total hypoglycemic events [blood glucose (BG) ≤54 mg/dL (≤3.0 mmol/L)] at week 24.

RESULTS:

Of the 259 patients enrolled, 64.1% were males, had mean [standard deviation (SD)] age 52.1 (11.38) years, and had diabetes for mean (SD) 6.75 (5.16) years. The mean HbA1c (SD) levels significantly improved from baseline to week 24 [-1.03 (1.554); p <0.0001] and Basaglar titration doubled from baseline. Total hypoglycemic events were reported in 10 (3.86%), 7 (2.70%), and 4 (1.54%) patients during weeks 0-24, 0-12, and 12-24, respectively. Ten patients (3.90%) reported 12 adverse events (AE; 11 mild and moderate, one severe). One death, unrelated to Basaglar, was reported.

CONCLUSION:

Basaglar was well tolerated with few hypoglycemic events and significantly reduced HbA1c and BG from baseline in Indian insulin-naïve patients with T2DM.

2025-01-01·BMJ Open

Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries

Article

作者: Morolla, Davide ; von Schoen-Angerer, Tido ; Ewen, Margaret ; Beran, David ; Raviglione, Mario

Objective:

Quantify insulin glargine prices following the market introduction of biosimilars. Examine price levels and price changes for originator and biosimilars, by country.

Methods:

Retrospective quantitative analysis using insulin glargine pricing data, both of the originator product and its biosimilars. Segmented regression analysis using a dual-model approach: pooled and country-specific.

Setting:

28 European countries using data from the European Medicine Price Database for the period 2013–2023.

Main outcome measures:

Price variations between countries were analysed to assess trends and correlations before and after biosimilar market entry.

Results:

In the 28 countries studied, cost of insulin glargine underwent a median 21.6% decrease overall in the last decade (p<0.001). In 2022, the median price was €9.0 for the originator (first to market) Lantus (IQR €8.1–€10.4), €8.9 for the biosimilar Abasaglar (IQR €7.6–€10.1) and €7.0 for the biosimilar Semglee (median €7.0; IQR €6.8–€7.5). The originator price was higher than biosimilars (p=0.009). Biosimilar market entry was associated with an overall significant price reduction of the originator, both immediately after entry (p<0.001) and in the long-term postentry (p<0.001). No significant correlation was observed between the price of insulin and the countries’ economic indicators.

Conclusion:

This is the first study to show the price trend of insulin glargine and its correlation with the introduction of biosimilars, in Europe. A significant price reduction of the originator was observed after biosimilars entered the market. The median cost of biosimilars was lower than the originator, although with substantial differences between individual countries and producers.

224

项与甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的新闻（医药）

2025-06-24

·医学新视点

一年少打约300针！NEJM、Lancet三连发：每周一次，长效胰岛素有效降糖

约三分之一的2型糖尿病患者在确诊后8年内需要胰岛素治疗。对低血糖的担忧和高频注射胰岛素带来的不便会让患者难以坚持按最佳剂量使用胰岛素。近年来，长效胰岛素的出现正在改变这样的挑战。Efsitora是一种每周一次皮下注射的基础胰岛素，它是一种融合蛋白，结合了新型单链胰岛素变体与人IgG2 Fc结构域。Efsitora与人胰岛素受体的结合亲和力比内源性胰岛素弱约两个数量级，这意味着这可以延长胰岛素活性，作用时间更长；同时，由于其具有较低的峰谷比，有望在整一周内帮助患者保持更稳定的血糖水平。QWINT系列研究评估了efsitora的安全性和有效性。此前发表的QWINT-2试验显示，在未接受过胰岛素治疗的2型糖尿病成人中，每周一次的efsitora治疗52周降低糖化血红蛋白（HbA1c）的效果不劣于每日一次的常用基础胰岛素；QWINT-5试验在1型糖尿病成人患者中证实了这一点。在第85届美国糖尿病协会（ADA）学术会议上，QWINT-1、QWINT-3和QWINT-4的积极结果公布，并分别同步发表于《新英格兰医学杂志》（NEJM）和《柳叶刀》（The Lancet）。这三项试验分别针对首次使用胰岛素、既往使用每日基础胰岛素、既往使用每日基础胰岛素和餐时胰岛素的2型糖尿病成年患者。在每项试验中，每周一次的efsitora在降低HbA1c方面均不劣于常用的每日基础胰岛素，且总体安全性相似。这三项研究的结果强化了efsitora通过每周给药简化胰岛素管理的潜力，意味着患者有望每年可减少近300次的胰岛素注射。QWINT-1试验：针对首次使用胰岛素患者截图来源：The New England journal of medicineQWINT-1试验是一项为期52周的开放标签、达标治疗3期试验，共795名既往未接受过胰岛素的2型糖尿病成年患者接受随机分组，按1:1接受每周一次的efsitora或每日一次的甘精胰岛素U100治疗。Efsitora采用固定剂量方案，初始剂量为每次100单位，此后每4周按需调整剂量，递增至每次150、250和400单位，以达到空腹血糖80~130 mg/dL的治疗目标。甘精胰岛素的剂量根据标准算法每周或更频繁地调整，以达到相同的血糖目标值。按治疗方案评估（无论患者依从性如何，或是否引入其他挽救治疗），efsitora组患者的平均HbA1c水平从基线时8.20%降至第52周时的7.05%，降低1.19%；而对照组患者从8.28%降至7.08%，降低1.16%；组间降幅差异为-0.03%（95%CI 0.18%~0.12%），落在非劣效性界值（0.4%）内，证实了efsitora不劣于对照胰岛素。在第52周时，efsitora组更多患者达到HbA1c水平＜7.0%（57% vs 52%）。与对照组相比，efsitora导致的低血糖事件减少了43%（RR 0.57，95%CI 0.39~0.84）：在52周时，临床显著低血糖事件（<54 mg/dL）或严重（3级）低血糖事件的估计发生率在efsitora组和对照组分别0.50次/患者-年和0.88次/患者-年。Efsitora组患者的胰岛素用量更低，平均胰岛素总剂量为289.1单位/周，而对照组为332.8单位/周，efsitora组剂量调整需求更少，中位数为2次，而对照组为8次。QWINT-3试验：针对已使用基础胰岛素治疗患者截图来源：The LancetQWINT-3是一项为期78周的开放标签、达标治疗3期临床试验，共有986名目前接受基础胰岛素治疗（不含餐时胰岛素）、最多接受三种非胰岛素降糖药物且血糖控制不佳（HbA1c水平在6.5%-10.0%之间）的2型糖尿病成年患者参与随机分组，按2:1接受每周一次efsitora（n=655）或每日一次德谷胰岛素（n=331）。根据患者基线时的空腹血糖浓度选择不同的起始剂量，每周评估并按需调整胰岛素剂量，直至第12周，之后每月调整一次，以达到目标空腹血糖浓度为80-120 mg/dL。所有患者均至少接受过一剂研究治疗，871名（88%）完成了78周的治疗。按治疗方案估计，从基线到第26周，efsitora组的平均HbA1c水平从7.80%下降至6.99%，降低0.81%；对照组患者从7.79%下降至7.08%，降低0.72%；组间降幅差异为-0.09%（95%CI 0.19~0.01），符合非劣效性界值（0.4%），表明efsitora不劣于对照胰岛素。此外，从基线到第52周，efsitora组的HbA1c水平降幅显著更大（降低0.78% vs 降低0.59%；p=0.0014）。两组患者从基线到第78周的HbA1c水平变化相似。从连续血糖监测结果来看，在第52周前的4周监测期间，efsitora组血糖患者的24hr内血糖达标时间更高，但两组患者在26周和78周时的数据相似。安全性方面，从基线到第78周，两组患者的2级低血糖或3级（严重）低血糖事件发生率相似（RR 1.14，95%CI 0.83~1.56；p=0.43），efsitora组为0.84次/患者-年，对照组为0.74次/患者-年。Efsitora组16%患者、对照组11%患者发生了严重不良事件，其中分别有7例（1%）和1例（＜1%）与治疗有关。试验期间有9人死亡（efsitora组7人，degludec组2人），但均与研究治疗无关。QWINT-4试验：针对已使用基础胰岛素和餐时胰岛素的患者截图来源：The LancetQWINT-4是一项为期26周的开放标签、达标治疗3期试验，共730名既往使用基础胰岛素和餐时胰岛素以及最多三种非胰岛素降糖药物治疗、且HbA1c水平为7.0%-10.0%的2型糖尿病患者按1:1随机分组接受efsitora（n=365）或每日一次甘精胰岛素（n=365）治疗。治疗期间，所有参与者均接受餐时赖脯胰岛素治疗。根据患者基线时的空腹血糖浓度选择不同的起始剂量，每周评估并按需调整胰岛素剂量，直至第12周，之后每月调整一次，以达到目标空腹血糖浓度为80-120 mg/dL。按治疗方案估计，从基线到第26周，efsitora组患者的平均HbA1c水平从8.18%下降至7.17%，降低1.01%；对照组患者从8.18%下降至7.18%，降低1.00%；组间降幅差异为-0.01%（95%CI -0.14~0.12），符合非劣效性界值（0.4%），表明efsitora不劣于对照胰岛素。在第26周前的4周连续血糖监测期间，两组患者在24hr内血糖达到、高于、低于目标区间的时间比例均没有显著差异。第26周时，efsitora组的每周胰岛素总剂量（592.9单位/周 vs 666.4单位/周）、每周基础胰岛素剂量（391.6单位/周 vs 426.6单位/周）和平均每日餐时胰岛素剂量（27.0单位/日 vs 34.6单位/日）都明显更低。治疗期间，两组患者的总体2级或3级低血糖发生率相似（6.6次/患者-年 vs 5.9次/患者-年；ERR 1.11，95%CI 0.85~1.44；p=0.44）；两组不良事件发生率相似，efsitora组7%和对照组6%的患者报告了严重不良事件。图片来源：123RF根据公开信息，礼来公司计划在今年年底前向全球监管机构提交efsitora用于治疗成人2型糖尿病的上市申请，期待这款长效胰岛素早日为患者带来更便捷的血糖管理选择。推荐阅读每周一次，减重20.4%；血糖达标率超70%！NEJM连发两篇，双靶点疗法带来多重获益新药每周一次，93%中国患者成功减重，还降三高、尿酸和脂肪肝！纪立农教授领衔研究登《柳叶刀》子刊每周一次，不仅降糖，还能减重、减少使用胰岛素！《柳叶刀》子刊：新药为2型糖尿病治疗提供新选择每周一次，强效降糖！《柳叶刀》子刊：新药包含两大明星药成分，低血糖风险更低NEJM：每周一次，82%患者至少减重5%！中国患者有望在今年用上新药欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。封面图来源：123RF参考资料（可上下滑动查看）[1] Julio Rosenstock, et al., (2025). Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. The N Engl J Med, DOI: 10.1056/NEJMoa2502796[2] Julie R. Ingelfinger, Clifford J. Rosen. (2025). Weekly Insulins and Therapeutic Burden in Type 2 Diabetes. The N Engl J Med, DOI: 10.1056/NEJMe2508147[3] Athena Philis-Tsimikas, et al., (2025). Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. Lancet, DOI: 10.1016/S0140-6736(25)01044-X[4] Thomas Blevins, et al., (2025). Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. Lancet, DOI: 10.1016/S0140-6736(25)01069-4 External Link[5] Edith Wing-Kar Chowa, Elaine Chowa. (2025). Future of once-weekly insulins in type 2 diabetes: efficacy and safety. Lancet: DOI: 10.1016/S0140-6736(25)01098-0[6] Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials. Retrieved June 24, 2025 from https://investor.lilly.com/news-releases/news-release-details/lillys-once-weekly-insulin-efsitora-alfa-demonstrated-a1c免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

临床结果临床3期

2025-06-24

·求实药社

即将上市！礼来胰岛素周制剂3项III期研究结果公布

来源：医药魔方Info6月22日，礼来宣布了QWINT-1、QWINT-3和QWINT-4这3项III期研究的详细结果，这些研究评估了在成人2型糖尿病患者中胰岛素周制剂efsitora alfa（efsitora）的安全性和有效性。结果显示，efsitora在多项III期研究中显示出降低A1C的效果，且安全性与每日胰岛素一致。礼来计划在今年年底前向全球监管机构提交efsitora用于治疗成人2型糖尿病的上市申请。胰岛素efsitora是一种融合蛋白，结合了一种新型单链胰岛素变体和人IgG2 Fc结构域。它专为每周一次皮下给药而设计，凭借其低峰谷比，有望提供更稳定的血糖水平（减少血糖波动）。这3项研究的患者分别为首次使用胰岛素、之前使用过每日基础胰岛素以及之前同时使用过每日基础胰岛素联用餐时胰岛素治疗的患者。在每项试验中，每周一次的efsitora均达到了与每日基础胰岛素相比A1C降低非劣效的主要终点。这些研究的完整结果在2025年美国糖尿病协会（ADA）第85届科学会议上公布。同时，QWINT-1（一项首创的固定剂量研究）的结果发表于《新英格兰医学杂志》，而QWINT-3和QWINT-4的结果则发表于《柳叶刀》。在QWINT-1研究中，efsitora使A1C降低了1.31%，而甘精胰岛素降低了1.27%，在第52周达到疗效估计量。在该试验中，efsitora根据需要每四周调整至四个固定剂量，以控制血糖。在QWINT-3中，efsitora使A1C降低了0.86%，而德谷胰岛素降低了0.75%，在第26周达到疗效估计量。在QWINT-4中，efsitora使A1C降低了1.07%，与甘精胰岛素的1.07%相当，在第26周达到疗效估计量。在这两项试验中，efsitora采用传统胰岛素给药方式，根据每位患者的血糖水平进行调整。在上述三项试验中，efsitora显示出与两种最常用的每日基础胰岛素治疗2型糖尿病的安全性相当。在QWINT-1中，与甘精胰岛素相比，efsitora导致的低血糖事件减少了约40%，在52周内，两组的严重或具有临床意义的低血糖事件估计综合发生率分别为0.50 vs. 0.88（患者/年）。在QWINT-3中，在78周内时，德谷胰岛素相比，上述事件的发生率分别为0.84 vs. 0.74（患者/年）。在QWINT-4中，在26周内与甘精胰岛素相比，efsitora组的严重或具有临床意义低血糖事件估计综合发生率分别为6.6 vs. 5.9（患者/年）。礼来产品开发高级副总裁Jeff Emmick博士表示：“建立在礼来胰岛素治疗领域创新传统的基础上，每周一次的efsitora可能为需要胰岛素的2型糖尿病患者带来重大进步，每年减少300多次注射。这些结果强化了每周一次efsitora通过简化治疗方案减轻胰岛素治疗负担的潜力。我们期待与监管机构合作，将这一创新带给全球患者。”免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们国内唯一！多肽、代谢与减肥药领域顶尖盛会！PMO 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多精彩！

临床结果临床3期临床成功临床2期

2025-06-24

·PMLiVE

Eli Lilly shares promising phase 3 results for once-weekly insulin candidate efsitora alfa

Eli Lilly has shared promising phase 3 results for its once-weekly insulin candidate efsitora alfa in adults with type 2 diabetes (T2D). All three studies met their primary endpoint of non-inferior A1C reduction compared to daily basal insulin, according to data presented at this year’s American Diabetes Association Scientific Sessions. More than 4.3 million people in the UK have diabetes, with T2D accounting for around 90% of all cases. Current treatment options focus on disease management and include diet and exercise, diabetes medications and insulin therapy. It is hoped that an insulin option specifically designed for once-weekly subcutaneous administration could improve adherence rates and quality of life for patients with the chronic condition. QWINT-1, which evaluated efsitora alfa in patients using insulin for the first time, showed that Lilly’s candidate reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52. In the trial, efsitora was titrated across four fixed doses at four-week intervals, as needed for blood glucose control. In QWINT-3 and QWINT-4, which enrolled patients who had previously used daily basal insulin, and those who had previously used daily basal insulin and mealtime insulin, respectively, efsitora was given using traditional insulin dosing, with adjustments based on each patient’s glucose level. At week 26 in QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec. At the same time point in QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine. Efsitora also demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for T2D across all three studies. Jeff Emmick, senior vice president of product development at Lilly, said: “These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach.” Lilly said it is planning to submit global regulatory applications for efsitora as a treatment for adults with T2D by the end of this year. “We look forward to working with regulatory agencies to bring this innovation to patients around the world,” Emmick said.

临床结果临床3期

100 项与甘精胰岛素生物类似药(Boehringer Ingelheim) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03250	甘精胰岛素生物类似药(Boehringer Ingelheim)	A10AE04	DB00047

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
1型糖尿病	美国	Eli Lilly & Co.	2015-12-16
2型糖尿病	美国	Eli Lilly & Co.	2015-12-16
糖尿病	欧盟	Eli Lilly Nederland BV	2014-09-09
糖尿病	冰岛	Eli Lilly Nederland BV	2014-09-09
糖尿病	列支敦士登	Eli Lilly Nederland BV	2014-09-09
糖尿病	挪威	Eli Lilly Nederland BV	2014-09-09

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临床结果

适应症

分期

评价

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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


NCT04153981 (CTgov)	临床4期	2型糖尿病	304	Insulin Glargine	齋餘衊觸蓋糧鹽構鏇鏇 = 觸簾觸鏇鬱簾簾夢顧壓衊繭鬱壓願網襯願憲夢 (簾網獵糧糧繭顧廠鏇簾, 膚鹽顧膚膚積夢遞廠築 ~ 窪範餘衊製構選淵壓壓) 更多	-	2024-02-15
NCT03338023 (Pubmed) 人工标引	临床3期	1型糖尿病	272	insulin lispro+LY2963016	獵糧鑰顧遞選鹽淵積艱(鑰顧衊餘鬱鏇醖壓鹽鹽) = 艱夢醖鹹夢膚繭鑰鬱網積製觸膚鏇範衊廠憲鏇 (壓廠糧窪鹽衊鏇鬱鹹憲, 0.07)	相似	2021-10-01
				insulin lispro+insulin glargine	獵糧鑰顧遞選鹽淵積艱(鑰顧衊餘鬱鏇醖壓鹽鹽) = 衊鏇鑰糧齋網醖廠鏇觸積製觸膚鏇範衊廠憲鏇 (壓廠糧窪鹽衊鏇鬱鹹憲, 0.07)
NCT03338010 (Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	536	LY2963016	製鏇襯鹹衊鏇鑰構窪鑰(簾窪鹹構廠壓餘鑰築壓) = 襯膚簾衊觸壓醖範鬱夢網願遞壓衊夢艱衊壓糧 (顧遞構壓獵遞積遞鹹遞 )	非劣	2021-08-01
				insulin glargine	製鏇襯鹹衊鏇鑰構窪鑰(簾窪鹹構廠壓餘鑰築壓) = 淵膚壓糧憲襯艱壓觸積網願遞壓衊夢艱衊壓糧 (顧遞構壓獵遞積遞鹹遞 )
NCT03338010 (CTgov)	临床3期	2型糖尿病	536	LY2963016 (LY2963016)	簾網夢觸遞築積觸壓築(顧選夢淵網觸繭獵獵簾) = 築艱齋觸襯鹹窪構製艱願遞築構襯蓋鬱網餘鬱 (艱壓鹹構廠夢糧築積壓, 0.043) 更多	-	2021-05-25
				Lantus® (Lantus®)	簾網夢觸遞築積觸壓築(顧選夢淵網觸繭獵獵簾) = 繭壓範築艱遞廠壓鹹築願遞築構襯蓋鬱網餘鬱 (艱壓鹹構廠夢糧築積壓, 0.062) 更多
NCT03338023 (ABES, CTgov)	临床3期	1型糖尿病	272	LY2963016+Insulin Lispro (LY2963016 + Insulin Lispro)	範壓獵願製選淵壓淵鹹(觸製構獵網壓獵鏇遞遞) = 鹹夢蓋鬱簾鹹齋襯壓淵糧艱鹹範築憲範簾艱選 (窪鹹觸觸遞襯窪蓋選糧, 0.071) 更多	-	2021-03-29
				Lantus®+Insulin Lispro (Lantus® + Insulin Lispro)	範壓獵願製選淵壓淵鹹(觸製構獵網壓獵鏇遞遞) = 膚範窪鑰遞獵範繭構網糧艱鹹範築憲範簾艱選 (窪鹹觸觸遞襯窪蓋選糧, 0.071) 更多
NCT03555305 (CTgov)	临床1期	-	58	Insulin Glargine (0.5 U/kg Insulin Glargine)	遞憲鹹鹽築糧築鑰顧憲(獵餘醖願鑰憲範鹽衊繭) = 範鏇壓簾餘製衊淵築淵築鬱襯獵範鬱襯衊簾蓋 (製膚網構構膚膚製鹹蓋, 31) 更多	-	2020-11-24
				Lantus (0.5 U/kg Lantus)	遞憲鹹鹽築糧築鑰顧憲(獵餘醖願鑰憲範鹽衊繭) = 積窪鏇衊鏇觸齋襯築築築鬱襯獵範鬱襯衊簾蓋 (製膚網構構膚膚製鹹蓋, 33) 更多
NCT02302716 (ELEMENT 5, Pubmed) 人工标引	临床3期	2型糖尿病	493	Insulin Glargine	顧選窪獵鏇築簾廠顧願(鹽蓋選鹹憲觸網醖鬱廠) = 鹹觸獵鹽窪觸築糧鹹構夢鹽鏇築鏇範積艱築鬱 (襯繭選鹹蓋構襯簾鹹齋 )	相似	2019-02-01
				Lantus	顧選窪獵鏇築簾廠顧願(鹽蓋選鹹憲觸網醖鬱廠) = 餘鏇築鑰鏇構齋願簾獵夢鹽鏇築鏇範積艱築鬱 (襯繭選鹹蓋構襯簾鹹齋 )
NCT02302716 (ELEMENT 5, CTgov)	临床3期	2型糖尿病	493	LY2963016+Oral Antihyperglycemic Medication (LY2963016)	憲製壓製鹹衊鹹鹽鑰遞(糧醖鏇鹽廠範蓋艱觸餘) = 膚壓積膚壓廠積網鹹選觸鏇製選範積壓鑰鏇夢 (鬱繭廠鹽鹽艱糧淵餘鹹, 0.066) 更多	-	2017-10-24
				Oral Antihyperglycemic Medication+LANTUS® (LANTUS®)	憲製壓製鹹衊鹹鹽鑰遞(糧醖鏇鹽廠範蓋艱觸餘) = 蓋壓顧鑰糧築觸醖顧顧觸鏇製選範積壓鑰鏇夢 (鬱繭廠鹽鹽艱糧淵餘鹹, 0.067) 更多
NCT01421459 (ELEMENT 2, Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	756	LY2963016	壓構構製鑰齋獵艱鑰鏇(遞淵繭範築遞選齋鬱願) = 夢範構範壓觸膚選窪鏇壓糧艱齋鑰遞廠膚壓醖 (選醖顧憲憲壓艱築廠顧 )	积极	2015-08-01
				insulin glargine	壓構構製鑰齋獵艱鑰鏇(遞淵繭範築遞選齋鬱願) = 齋廠窪顧艱鏇齋淵鹽製壓糧艱齋鑰遞廠膚壓醖 (選醖顧憲憲壓艱築廠顧 )
NCT01421147 (ELEMENT 1, CTgov)	临床3期	1型糖尿病	536	LY2963016+Insulin Lispro (LY2963016 + Insulin Lispro)	鏇製窪蓋鑰窪繭膚鑰鏇(廠觸蓋積製觸築廠製積) = 觸餘膚襯窪簾膚鑰製糧窪網積網鹽鬱鹹壓夢鏇 (繭簾築淵積膚觸網衊糧, 0.053) 更多	-	2014-10-09
				Lantus+Insulin Lispro (Lantus + Insulin Lispro)	鏇製窪蓋鑰窪繭膚鑰鏇(廠觸蓋積製觸築廠製積) = 膚製艱膚製遞鑰構壓顧窪網積網鹽鬱鹹壓夢鏇 (繭簾築淵積膚觸網衊糧, 0.054) 更多