This study is designed to investigate the movement of insulin NNC0363-0845 throughout the body and how it works for the treatment of type 1 diabetes mellitus.
The aim of the study is to improve clinical outcomes for patients with type 1 diabetes mellitus by better controlling the blood sugar levels.
Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®). NNC0363-0845 is a new insulin molecule designed to provide blood sugar-dependent insulin action, while insulin detemir is commonly used and prescribed by doctors.
Participants will get subcutaneous (under your skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days, and of insulin detemir up to 6 times daily for another 3 days. Which medication participants receive first and which second, insulin NNC0363-0845 or insulin detemir, is decided by chance.
The study will last for about 6 weeks up to a maximum of 14 weeks. Participants will have 2 in-house visits (where participants will stay at the site for 4 nights) and 5 outpatient visits with the study doctor. Participants will have frequent contact with the study doctor during the study.
During the in-house visits, two intravenous catheters (a thin tube inserted into a vein) will be inserted for blood sampling and infusions.
Interested parties may not participate in the study if the study doctor believes it will affect their health negatively.
Women cannot take part if they are of childbearing potential.

开始日期2021-12-01

申办/合作机构

Novo Nordisk A/S

NCT03960814 / CompletedN/A

Retrospective Cohort Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine

This study will examine the influence of the basal insulins detemir and glargine on risk of cardiovascular death and death from all causes in patients treated by their general practitioner in United Kingdom (UK). The data for this study will be drawn from the Clinical Practice Research Datalink (CPRD) Register.

开始日期2019-05-21

申办/合作机构

Novo Nordisk A/S

100 项与地特胰岛素相关的临床结果

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100 项与地特胰岛素相关的转化医学

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100 项与地特胰岛素相关的专利（医药）

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998

项与地特胰岛素相关的文献（医药）

2024-09-10·Clinical diabetes and endocrinology

Long-term TNF-alpha therapy for preserving beta cell function in new onset type 1 diabetes: a case report.

Article

作者: Rao, Adya ; Narendran, Parth ; Quinn, Lauren M

BACKGROUND:

Type 1 diabetes mellitus (T1D) is an autoimmune disease caused by destruction of pancreatic islet beta-cells. There is significant residual beta-cell function, measured through circulating C-peptide, present at the time of T1D diagnosis but this subsequently decreases with time. Higher residual beta-cell function at diagnosis associates with better glycaemic control and less glucose variability, and later in the disease course with less hypoglycaemia, lower glucose variability and fewer microvascular complications. There is therefore value in preserving residual beta cell function in new onset T1D Immunotherapeutic agents can protect residual beta-cell function in type 1 diabetes. However, clinical trials of such agents, whilst demonstrating C-peptide preservation in short term studies, have yet to be taken forward into routine clinical care due to concerns around safety and long-term efficacy. Here we report the case of a gentleman with newly diagnosed T1D whose glycaemic control and insulin requirement improved whilst on a five year infusion programme of infliximab, a monoclonal antibody against TNF-alpha, for colitis.

CASE PRESENTATION:

A 52-year-old White Caucasian man was diagnosed with T1D in August 2018. Glucose was 25.6 mmol/L, HbA1c was 98mmol/mol and GAD antibodies were strongly positive. HbA1c marginally improved to 91mmol/mol following initiation of insulin detemir 5 units at night and 1:10 g of insulin aspart (November 2018). In June 2019, he developed rectal bleeding and abdominal pain. Following colonoscopy, he was diagnosed with "indeterminate colitis" and commenced on 6-weekly infusions of 400-450 mg infliximab. Thus far, he has received 32 doses and achieved colitis remission. Following infliximab initiation there was increased frequency of mild-moderate hypoglycaemia and he was gradually weaned off and discontinued detemir in June 2020. Since then, HbA1c improved from 57mmol/mol in August 2019 to 52mmol/mol in April 2022, remaining stable at 51mmol/mol. His most recent HbA1c is 54mmol/mol in February 2024. His c-peptide was 550pmol/L in October 2022 and 442pmol/L in February 2024, suggesting well-preserved beta-cell function almost 6 years post-diagnosis.

CONCLUSIONS:

Our patient's improvement in glycaemic control can be explained by immunomodulation and C peptide preservation from infliximab. With the growing focus on type 1 diabetes disease modulation and working towards an 'insulin free T1D', our findings strengthen the evidence base for the repurposing of and long-term treatment with anti-TNF-α agents to preserve beta-cell function in new onset T1D.

2024-09-01·Journal of diabetes science and technology

Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches

Article

作者: Green, Nancy ; Girard, Michel ; Lorbetskie, Barry ; Klein, Agnes V. ; Zhang, Xu ; Sauvé, Simon ; Rosu-Myles, Michael ; Walrond, Lisa ; Loo, Shih-Miin ; Lu, Huixin ; Bigelow, Stewart

Background::

For diabetes mellitus treatment plans, the consistency and quality of insulin drug products are crucial for patient well-being. Because biologic drugs, such as insulin, are complex heterogeneous products, the methods for drug product evaluation should be carefully validated for use. As such, these criteria are rigorously evaluated and monitored by national authorities. Consequently, reports that describe significantly lower insulin content than their label claims are a concern. This issue was raised by a past publication analyzing insulin drug products available in Canada, and, as a result, consumers and major patient organizations have requested clarification.

Methods::

To address these concerns, this study independently analyzed insulin drug products purchased from local Canadian pharmacies—including human insulin, insulin analogs, and porcine insulin—by compendial and noncompendial reversed-phase high-performance liquid chromatography (RP-HPLC) methods.

Results::

We demonstrated the importance of using methods fit for purpose when assessing insulin quality. In a preliminary screen, the expected insulin peak was seen in all products except two insulin analogs—insulin detemir and insulin degludec. Further investigation showed that this was not caused by low insulin content but insufficient solvent conditions, which demonstrated the necessity for methods to be adequately validated for product-specific use. When drug products were appropriately assessed for content using the validated type-specific compendial RP-HPLC methods for insulin quantitation, values agreed with the label claim content.

Conclusions::

Because insulin drug products are used daily by over a million Canadians, it is important that researchers and journals present data using methods fit for purpose and that readers evaluate such reports critically.

2024-08-01·PHARMAZIE

Optimization of a mass spectrometric analytical method for the quality assessment of insulin and its analogs.

Article

作者: Andrási, M ; Nebija, D ; Pajaziti, B A ; Pajaziti, B ; Kemlendi, N

The principal aim of this study was to optimize analytical methodology based on mass spectrometry for the evaluation of the quality of recombinant human insulin and its analogs. In this study ESI-MS was used to assess the quality of human insulin, short acting insulin analogs, insulin lispro, insulin aspart and insulin glulisine and long acting analogs including insulin glargine, insulin degludec, and insulin detemir, in respective pharmaceutical formulations. In this study, with the aimed to optimize analytical conditions, different factors influencing the analytical performance such as pH, ionic strength, sample dilution, organic solvent addition were addressed. The study results demonstrated that MS is a suitable technique for the analysis of biotechnological compounds like insulin and its analogs. Although the obtained results provide an important information regarding this methodology, further studies are needed to validate this analytical approach and check for its suitability to be used in the regulatory environment.

项与地特胰岛素相关的新闻（医药）

2024-09-29

·循因缉药

胰岛素，降价直到消失

环球视野，深度视角各位亲爱的股东们，大家早上好中午好晚上好。各位朋友们，准备国庆放假了，撒花~ 理论上，应该会继续保持更新。质量上，应该不一定能保证。比如今天，就是纯水...如果堵车，可以顺便刷刷...因为这将浪费您一分钟的时间。 2024年3月14日，糖尿病治疗领域的巨头诺和诺德宣布降低美国胰岛素产品的售价，最高降价高达75%。当然，你要说这是美国版“集采”IRA（inflation reduction act）的“淫威”之功，似乎也没错。反正，至少看起来美国人民要享福了。拜登：家人们，咱们赢麻了！大统领拜登急不可耐的宣布，家人们，我们赢麻了。也确实，美国人民此前一个月的胰岛素都要花个400美元以上。降价后，比如预填充的FlexPen Novolin“仅需”91.09美元，还可以通过My$99Insulin计划以99美元买到30天的用量。（Novolin FlexPen 300units）然而，这些药企明修降价栈道，暗渡减产停产陈仓的消息就不绝于耳。诺和诺德此前曾表示，2024年底将彻底停止长效胰岛素产品Levemir在美国的生产。而这一骚操作也引起了美国国会的注意，CEO被拉过去质询了一番。然而，根据Endpoints报道，诺和诺德将大幅减产部分胰岛素注射笔，并将部分产能生产注射器用胰岛素。就是那种常规的，注射比较麻烦的胰岛素（成本更低）。据说减产是因为胰岛素注射笔产能受限造成的.... 2024年9月26日，位于日内瓦的无国界医生组织（Médecins sans frontières，MSF）更是直接发公告指责诺和诺德双标，原因是诺和诺德准备停产胰岛素注射笔的供应。 MSF直言不讳的指出，别整那些什么注射笔产能不足的问题，你们就是想卖高价的GLP-1（司美格鲁肽）。他们表示，根据来自JAMA的一个研究指出胰岛素最低也就值0.93美元一支，还包含利润。当然，MSF做过很多令人尊敬的事业，抛出这个价格也是一种策略。真正要是干到0.93美元一支，相信真没多少企业愿意干。特别是礼来、诺和诺德等大药企，他们宁可让这些胰岛素产品彻底消失。不如这样，我出一个主意。加入我国带量采购谈判，上表是国家组织药品联合采购办公室2024年的胰岛素专项接续有效申报价。虽然没有干到0.93美元一支，但是好在产品线齐全，且大概率不会停产。还可以带上美国政府一起来，这样说不定还有空间。就差哪位大统领能有这个魄力，真正站在人民这一边走出这一步。大家觉得，这有没有可能呢？哦对了，2023年全年营收2322.61亿丹麦克朗，约330亿美元。净利润836.83亿丹麦克朗，约合125.29亿美元。 Levemir在美国的销售额约为12.73亿丹麦克朗，约占全球销售量的一半。不挣钱，根本不挣钱，必须停掉低利润的产品。 END 啊对对对对，扫描这货能联系到我至此，各位股东星标了么？点赞了么？转发了么？在看了么？谢谢！所有内容均不作为投资建议，信息均来自公开资料。近期文章：单细胞DNA测序要出息了？燃石董事、CFO辞任 FDA Warning|交叉污染、玻璃碎渣和“尖端制造能力” Natera:专利诉讼我赢了！NeoGenomics:我跪还不行？相关资料：注1：https://www.novonordisk.com/news-and-media/latest-news/lowering-us-list-prices-of-several-products-.html注2：https://jamanetwork-com.libproxy1.nus.edu.sg/journals/jamanetworkopen/fullarticle/2816824注3：https://www.msfaccess.org/msf-calls-out-novo-nordisk-its-double-standard-approach-diabetes-corporation-plans-halt-supply

带量采购财报申请上市核酸药物

2024-09-28

·药闻康策

减肥药价格未来将如何演变？

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策礼来Zepbound（替尔泊肽）在2023年底获批上市后，诺和诺德和礼来在GLP-1领域的龙争虎斗延伸到价格战。诺和诺德的司美格鲁肽在针对2型糖尿病和肥胖症获批上市都领先礼来的替尔泊肽一步，在定价方面给礼来提供了参照标准，从这个角度来看，价格战可以说是礼来“挑起”的。礼来为替尔泊肽设定的标签价格为1060美元，明显低于诺和诺德的司美格鲁肽（1350美元，低21.5%）。虽然药物的标价通常高于患者实际支付的价格，但替尔泊肽低标价却明心见义地表明了礼来在价格上挑战司美格鲁肽的决心。两大龙头的价格战很有可能促进未来的GLP-1减肥药降价。这对于许多囊中羞涩的肥胖症患者来说意义重大。美国的药物价格体系非常复杂，患者很少支付药品的全部标价。药品经销商与制药公司协商降低价格，药店与经销商协商进一步压低价格。之后就是健康保险发挥作用了。诺和诺德称，在1.1 亿美国肥胖症患者中，大概有5000万人拥有肥胖者有减肥药保险。然而，健康政策研究非营利组织 KFF称，联邦保险Meidcare并不承保GLP-1减肥药，州政府的Medicaid承担这些药物的，全美只有16个州。美国肥胖医学委员会表示，低收入女性肥胖者比例很高，而这些人通常不太可能获得良好的保险覆盖。具体来看，FDA批准的三种GLP-1多肽减肥药利拉鲁肽（诺和诺德），司美格鲁肽（诺和诺德）和替尔泊肽（礼来），是否能获得保险覆盖，对患者来说有不小的差别。表1. GLP-1多肽药物及其价格表利拉鲁肽是是全球第一个被美国FDA(2014年)和欧洲EMA(2015年)批准用于减重的GLP-1RA。诺和诺德称，截至 2021 年 8 月，在商业保险覆盖下，约 80%患者每月的处方药价格低于30美元。利拉鲁肽的储蓄计划将于 12 月 31 日后停止，目前尚不清楚患者在 2024 年以后将为这款药物支付多少费用。拥有司美格鲁肽保险的人中，大约80%的患者每月在司美格鲁肽上的花费为 25 美元或更少。持有不承保该药物的商业保险计划的患者如果支付现金，可以获得一张储蓄卡，可以将总标价减少 500 美元。该卡最多可续配 12 次 28 天处方药。换句话说，如果没有商业保险，患者一个月的用量大约需要支付 850 美元。只有拥有商业或私人保险的人才有资格参加司美格鲁肽的储蓄计划。对于参加替尔泊肽储蓄卡计划的那些拥有商业保险的投保人来说，一个月或三个月的替尔泊肽处方费用可能低至25 美元。参加储蓄计划的患者如果拥有的商业保险不承保替尔泊肽，则可以最低550 美元的价格购买一个月的替尔泊肽处方药剂量。据礼来称，替尔泊肽从去年12 月 15 日开始被添加到 Cigna Healthcare 的商业处方中。目前尚不清楚那些没有商业保险的人将花多少钱购买替尔泊肽，而且替尔泊肽不允许那些已经被Medicare或Medicaid覆盖的患者参加其替尔泊肽储蓄卡计划。 -01- 竞争的尽头不一定是“价格战” 在大多数情况下，竞争会导致降价。但行业内也有竞争促进的药物价格上涨的先例。比如，胰岛素。在美国政府做出胰岛素价格封顶的要求之前，这个1型糖尿病人的救命药，价格在几大生产巨头之前是几乎是齐头并进地不断上扬。在诺和诺德、赛诺菲和礼来三大巨头的竞争之下，他们的胰岛素产品价格几乎如影随同一样地同步上涨，这种现象被称为“影子定价（Shadow Pricing）”。影子定价指的是公司通过观察竞争对手的价格行为来调整自己的定价策略，以维持相对固定的价格水平。这种定价策略是为了避免激烈的价格竞争，而更侧重于跟随竞争对手的价格变化，以维持相对市场份额和盈利水平。尽管存在激烈的市场竞争，但胰岛素的价格在过去十年中持续攀升，标价通常一年内上涨了一位或者两位的百分数。根据 Truven Health Analytics 的数据，赛诺菲的长效胰岛素 Lantus 的 10 ml瓶装于 2001 年首次进入美国市场，当时每瓶售价仅为 34.81 美元，而这个价格到了2014年已经飙升到了248.51美元。就在Lantus价格上扬600%的这个阶段，诺和诺德的竞争产品出现了。2006年，诺和诺德的新药Levemir以66.96美元的价格上市（接近赛诺菲Lantus当时的标价）。而Levemir的出现并没有打压对手的产品价格，相反，Levemir 的售价也随行就市地攀升到了269 美元（图1）。换句话说，竞争没有对压低价格产生任何影响。相反，两家公司“比学赶超帮”地在涨价方面开始了惺惺相惜的“同而不和”。图1. 赛诺菲的胰岛素Lantus与诺和诺德竞争产品Levemir的价格走势图。（图片来源：Truven Health Analytics）再让我们看看短效胰岛素（糖尿病患者进食时服用的胰岛素类型，或胰岛素泵中使用的胰岛素），礼来的Humalog和诺和诺德的NovoLog不同产品之间价格涨势图竟然出奇的心有灵犀，甚至于看不出这是两条走势线（图2）。图2. 短效胰岛素Humalog与NovoLog价格走势图。（图片来源：Truven Health Analytics）礼来的 Humalog 1996 年标价为 20.82 美元，现在售价为 255.40 美元，20 年来上涨了 1124%。诺和诺德的 Novolog 于 2001 年 8 月首次上市，售价为 39.75 美元，到了2016 年 7 月，每瓶标价为 255.40 美元，与 Humalog 别无二致。价格在竞争的环境下仍然能够不断攀升，尽管这种现象听上去不合逻辑，但在医药行业的大环境中似乎就可以找到注解，毕竟胰岛素的重要性不言而喻，而它的制造有掌握在几家巨头手中，只要他们之间达成一致，价格就可以按照Shadow Pricing的模式继续“朱门酒肉臭”下去。胰岛素并不是这方面的孤例，EpiPen同样是这种套路。 2009 年，Mylan从默克 (Merck KgAA) 手中收购了 EpiPen（肾上腺素注射笔，主要用于治疗过敏反应）。当时一包两支的 EpiPen 售价为 124 美元。到了2012 年底，EpiPen的价格已升至 241 美元。2013年1月，赛诺菲推出了EpiPen的竞争对手Auvi-Q，同样售价241美元。同年 7 月（制药公司通常选择1月或者7月对产品进行涨价），Mylan 将 EpiPen 的价格提高至 265 美元。两周后，赛诺菲将 Auvi-Q 标价提高至 277 美元，11 月 Mylan 将 EpiPen 上调至 304 美元，12 月赛诺菲将 Auvi-Q 上调至 334 美元。当赛诺菲因 2015 年因剂量问题而撤回 Auvi-Q 时，其标价已经升到了509 美元，EpiPen 的标价则为 461 美元（图3）。图3. EpiPen和Auvi-Q的价格涨势图。（图片来源：Forbes）涨了又涨的胰岛素价格，最终在天怒人怨下凭借美国政府的立法才在2023年1月服从了Medicare Part D 每月35美元的封顶价格。胰岛素和肾上腺素注射笔的案例说明，尽管在某个市场存在多个供应商，但这并不一定意味着产生了真正的竞争。在某些情况下，即使有多家公司提供相似的产品，市场仍可能受到垄断或寡头垄断的影响，从而导致价格同步上涨的现象。 · 价格领导者模式：在一些情况下，市场上的一家公司可能会设定价格，并且其他公司选择跟随这个价格。这种情况下，虽然存在多个公司，但它们的定价策略却相对一致。 · 行业共谋和行业公式：制药行业可能存在一种共识文化，竞争对手有时可能达成共识，共同提高价格，提高整个行业的盈利水平。这被称为行业共谋，这种协作行为可能违反反垄断法规，但有时它可能难以被监管机构察觉或证实。 · 产品特性和差异：虽然存在多个公司，但它们提供的产品可能在某些方面存在差异，使得患者难以在不同产品之间进行直接替代。这减少了价格对产品的敏感性，使得企业更容易调整价格而不失去市场份额。 · 同质化的产品：与上述的产品特性和差异的原因相反，如果不同公司提供的产品在性能、效果等方面差异不大，患者可能很难在它们之间找到明显的选择。这种同质化可能导致价格竞争的减弱，使得公司更容易进行协调定价。 · 需求不弹性：出于上述产品特性的差异，如果患者对于不同品牌的产品的需求不太弹性，即使价格上涨，他们也可能无法轻松转向其他选择。这可能减弱了患者对价格上涨的反应，使得企业更容易调整价格。 · 缺乏新竞争者进入市场：如果市场上没有新的竞争者进入，现有的公司可能没有足够的动力去降低价格以吸引患者。这可能与市场进入的壁垒、法规要求或其他因素有关。 -02- GLP-1 减肥药的价格走向？与其他 GLP-1 药物比，替尔泊肽相对较低的价格可能会对GLP-1药物未来的发展趋势产生影响。价格差异可能会鼓励市场竞争，有可能增加这些药物的可及性。但替尔泊肽的价格影响具体表现在何处，还将受到很多其他因素的影响，包括消费者需求、保险范围以及相关药物的涌现。尽管目前市场上存在着司美格鲁肽和替尔泊肽的竞争，但也不排除价格不降反升可能。诺和诺德和礼来已经通过提供优惠券和代金券的方式来降价。但这种促销手段应该存在时间限制，当促销过去，保险公司不会愿意去填补价格上涨的差异。从制造商的角度来看，礼来和诺和诺德都做出了巨额投资兴建生产机构，这也许显示出了他们并没有在短期对药物价格下调的意愿，否则付出的几十亿美元投资将不具备优良的成本效益。 GLP-1减肥药2024年的价格黜陟，将成为围绕这类药物的耐受性、停药反弹、新适应症拓展、供应链、保险覆盖等众多话题之中的又一个。（来源: 深蓝观）药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】 1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

上市批准临床研究

2024-09-27

·Endpoints

Novo Nordisk to decrease some insulin pen manufacturing, transition supply

Novo Nordisk has told government and global nonprofits that it plans to significantly downsize its manufacturing of some of its insulin pens, according to one of the groups, and will transition a portion of its global supply to insulin vials and syringes that are easier to make but less convenient for patients. The company’s plans were disclosed in recent discussions with Doctors Without Borders, who described them to Endpoints News , as well as the WHO, the Australian government, and other governments and regulators. “We are not halting production of insulin in pens,” Novo said in an email to Endpoints. “In some cases, we will no longer make human insulin available in pens. It will be made available in a vial and disposable syringe.” While some countries, like Australia and South Africa, are now seeking alternatives, the full extent of Novo’s plans isn’t immediately clear. The company declined to comment further to Endpoints on exactly which markets would be affected. And it said that some — but not all — insulin pens would be affected by the shift. And it emphasized that the changes would happen slowly, over a period of years. While South Africa in June announced shortages of insulin pens due to Novo’s decision to deprioritize their manufacture and supply, Doctors Without Borders’ pharmacist coordinator Christina Cepuch told Endpoints Friday that the latest announcement would go much further, based on the company’s comments to the groups. Geneva-based Doctors Without Borders is also known as Médecins Sans Frontières, or MSF. The WHO lists Novo’s insulin pens on its essential medicines list , and will also have to find alternatives, Cepuch said. The WHO did not immediately respond to a request for comment. “What does the WHO do about this? There’s not going to be any left. I mean, Lilly makes these, but they don’t make large volumes,” Cepuch said. “And what is WHO going to tell member states? Change everyone to glargine pens or go back to vials?” Glargine is a form of long-acting insulin, and Novo is currently in the process of phasing out its own long-acting insulin, called Levemir. On Tuesday, the Therapeutic Goods Administration, Australia’s drug regulator, released a short notice saying Novo will discontinue “some of its earlier generation insulin products” over the next two years. Scant on details, the notice said Australia is looking into alternatives. Novo emphasized to Endpoints that it is expanding its overall drug manufacturing significantly with the acquisition of Catalent and other new investments. Earlier this week, the Danish company’s CEO Lars Fruergaard Jørgensen testified before the US Senate at a hearing on drug prices and was asked by Sen. Tammy Baldwin (D-WI) about its insulin manufacturing plans. Baldwin asked Jørgensen if he would commit to “continue to have a focus on providing critical insulin. You will not reduce your manufacturing capacity in that area.” “The world market for insulin is actually declining, so there’s less demand,” Jørgensen responded. “But we are committed to supply to the patient that has been using our insulin for years also into the future.” Cepuch suggested that the company might decide to use freed-up pen capacity for its GLP-1 obesity products, which are also in shortage, or other insulins. Novo said the insulin and GLP-1 pens are different.

100 项与地特胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04539	地特胰岛素	A10AE05	DB01307

研发状态

批准上市

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	Novo Nordisk A/S	2005-10-19
2型糖尿病	美国	Novo Nordisk A/S	2005-10-19
糖尿病	欧盟	Novo Nordisk A/S	2004-06-01
糖尿病	冰岛	Novo Nordisk A/S	2004-06-01
糖尿病	列支敦士登	Novo Nordisk A/S	2004-06-01
糖尿病	挪威	Novo Nordisk A/S	2004-06-01

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
囊性纤维化相关糖尿病	临床3期	美国	Novo Nordisk A/S	2008-08-01
肥胖	临床3期	西班牙	Novo Nordisk A/S	2005-04-01
低血糖	临床3期	澳大利亚	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	克罗地亚	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	丹麦	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	意大利	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	南非	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	瑞典	Novo Nordisk A/S	2001-09-01

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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


ADA2022	N/A	2型糖尿病	-	Continued treatment with Gla-300	顧鏇糧構繭遞鬱壓範鹽(築醖壓蓋範齋淵鹹鹹簾) = 衊壓憲製餘憲觸鑰襯繭簾襯齋繭窪願壓夢願憲 (蓋襯憲網繭鑰鏇淵齋觸 ) 更多	-	2022-06-01
				Switched to 1st-gen BI analog (Gla-100 or IDet)	顧鏇糧構繭遞鬱壓範鹽(築醖壓蓋範齋淵鹹鹹簾) = 淵遞糧遞範醖築壓繭齋簾襯齋繭窪願壓夢願憲 (蓋襯憲網繭鑰鏇淵齋觸 ) 更多
NCT01186003 (CTgov)	N/A	糖尿病	30	insulin+detemir (Standard Insulin Drip Therapy)	構鏇窪憲壓範淵憲襯糧(顧積衊廠築鬱憲夢範鬱) = 醖鬱齋遞醖鹽鹹簾壓鏇憲餘鹽艱艱鹹鹹鏇願簾 (淵網衊構衊繭蓋鹹遞鏇, 鏇積願觸鹹壓鹽簾鹹顧 ~ 範選獵製積鬱廠願襯鏇) 更多	-	2021-12-07
				Detemir (Insulin Drip and Detemir)	構鏇窪憲壓範淵憲襯糧(顧積衊廠築鬱憲夢範鬱) = 膚醖範餘鏇艱選餘獵鬱憲餘鹽艱艱鹹鹹鏇願簾 (淵網衊構衊繭蓋鹹遞鏇, 積網製製膚遞衊獵遞網 ~ 繭鹽淵顧醖願簾鑰構繭) 更多
NCT03620890 (Determin, CTgov)	临床4期	2型糖尿病	108	Detemir insulin (Detemir)	鑰獵艱獵蓋網餘遞蓋壓(鬱窪範壓網鹹鹹膚糧醖) = 簾願廠蓋鹹膚壓廠願齋餘鹹顧餘網夢淵壓醖選 (繭選積網簾鹹願積衊鑰, 積積顧齋鹽餘襯遞鹹範 ~ 鏇獵壓窪觸憲遞鑰願築) 更多	-	2021-08-18
				Neutral Protamine Hagedorn (NPH) (Neutral Protamine Hagedorn (NPH))	鑰獵艱獵蓋網餘遞蓋壓(鬱窪範壓網鹹鹹膚糧醖) = 鏇膚醖範鹽襯鬱衊鏇窪餘鹹顧餘網夢淵壓醖選 (繭選積網簾鹹願積衊鑰, 繭壓蓋壓網襯繭夢夢積 ~ 網獵製憲膚廠壓壓獵膚) 更多
NCT02846233 (CTgov)	N/A	2型糖尿病	22	SGLT2 inhibitor+levemir+Lantus+Metformin (Treatment Group)	觸襯願夢網鑰構衊膚壓(願醖網遞鬱顧鬱構醖積) = 製糧鏇積壓夢淵餘網鑰膚齋淵窪衊鹹鹽廠鹽襯 (糧襯蓋願簾膚艱觸壓鏇, 鹽襯範醖鏇壓網築顧艱 ~ 顧範願壓構遞衊憲淵夢) 更多	-	2020-11-10
				SGLT2i (Control Group)	觸襯願夢網鑰構衊膚壓(願醖網遞鬱顧鬱構醖積) = 蓋壓齋夢簾鑰襯齋繭糧膚齋淵窪衊鹹鹽廠鹽襯 (糧襯蓋願簾膚艱觸壓鏇, 衊憲積範鹹蓋蓋顧觸鏇 ~ 艱窪窪壓鬱選鬱鏇鑰膚) 更多
ASN2020	N/A	慢性肾病	-	DPP-4 inhibitors	製襯製獵衊選鏇憲艱範(遞淵壓窪壓鏇築鹽膚憲) = 醖憲齋齋遞憲鬱願壓鏇憲齋顧築衊顧醖醖構鹹 (糧淵鬱醖網築蓋襯鏇鏇 )	-	2020-10-19
				GLP-1 receptor agonists	憲鹽築鏇製醖膚繭夢簾(願鹹壓鹽壓襯顧願顧積) = 蓋窪鹽齋衊鬱憲壓積願糧繭顧鹹蓋積壓鏇夢構 (襯鏇鏇獵顧襯醖製範築 )
EASD2020	N/A	2型糖尿病	-	NPH insulin	艱構築糧糧鹽鑰構糧鹽(顧顧網網淵廠簾願製壓) = 鹽觸觸網繭積淵製襯艱鑰醖鬱窪餘獵糧膚襯蓋 (獵選餘壓簾夢廠衊鏇鹹, 0.71 ~ 0.76)	-	2020-09-24
				Long-acting insulin analogs (glargine, detemir, degludec)	艱構築糧糧鹽鑰構糧鹽(顧顧網網淵廠簾願製壓) = 積淵積鬱製廠簾選齋窪鑰醖鬱窪餘獵糧膚襯蓋 (獵選餘壓簾夢廠衊鏇鹹, 0.02 ~ 0.03)
NCT01892319 (EVOLVE, EASD2020)	N/A	1型糖尿病 \| 2型糖尿病	-	Insulin Detemir (IDet)	觸餘網憲鏇鏇憲範獵憲(簾築願膚憲壓糧獵餘糧) = 餘鹽衊艱蓋獵襯構鏇艱齋糧艱範憲積餘願積衊 (鏇構鏇構選壓鏇選憲網 ) 更多	积极	2020-09-23
NCT00564018 (CTgov)	N/A	1型糖尿病	33	Insulin detemir (Detemir)	淵廠顧鏇蓋鑰壓構獵襯(簾襯壓鹽網繭網廠鏇夢) = 窪構製壓夢廠窪構鹹襯鹹窪網鏇築夢齋醖願構 (憲糧壓鹽鹹網遞衊壓築, 遞範鏇製襯餘鑰餘淵蓋 ~ 網範餘糧網鏇繭選齋衊) 更多	-	2019-10-11
				glargine (Glargine)	淵廠顧鏇蓋鑰壓構獵襯(簾襯壓鹽網繭網廠鏇夢) = 艱觸繭齋製淵淵繭鏇選鹹窪網鏇築夢齋醖願構 (憲糧壓鹽鹹網遞衊壓築, 壓鹽糧願醖餘蓋遞鏇憲 ~ 願艱膚醖衊獵選鏇餘鹹) 更多