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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1,037

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

BACKGROUNDType 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 PRESENTATIONA 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.CONCLUSIONSOur 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: Rosu-Myles, Michael ; Klein, Agnes V. ; Loo, Shih-Miin ; Lu, Huixin ; Green, Nancy ; Girard, Michel ; Walrond, Lisa ; Zhang, Xu ; Lorbetskie, Barry ; Sauvé, Simon ; 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·Die Pharmazie

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

Article

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

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）

2025-01-08

·echemi

80 batches of drugs recalled urgently! A major decision by the National Medical Products Administration

Recently, the National Medical Products Administration announced an important decision to stop the production, sale, and use of Hyoscine Butylbromide Tablets, and to revoke its drug registration certificate. According to the announcement issued by the National Medical Products Administration on January 3, titled “Announcement on the Revocation of the Drug Registration Certificate for Hyoscine Butylbromide Tablets (2025 No. 2)”, Hyoscine Butylbromide Tablets, an antibacterial drug also known as Loperamide, will no longer circulate in the market of our country. This decision is effective immediately, and the products already on the market will be recalled by the marketing authorization holder and supervised by provincial drug regulatory authorities for destruction or other harmless disposal measures. A total of 80 batches of Hyoscine Butylbromide Tablets are involved. In addition, in another announcement issued by the National Medical Products Administration on December 2, 2024, it was also announced that 58 drug registration certificates, including 11 batches of Hyoscine Butylbromide Tablets, have been revoked. Based on Article 83 of the Drug Administration Law of the People's Republic of China and other relevant regulations, these drugs have been required to stop production and sale due to unclear efficacy, serious adverse reactions, or other hazards to human health. Hyoscine Butylbromide Tablets are a compound preparation, with the main active ingredients including Hyoscine Tincture, Sulfamethoxazole, and Trimethoprim, primarily used to treat dysentery caused by Shigella and other sensitive pathogenic bacteria causing enteritis. However, with the withdrawal of this drug from the market, other drugs such as Montmorillonite Powder will take on the responsibility for treating diarrhea. According to data from Miiine, the incidence of gastrointestinal diseases is on the rise and is becoming more prevalent among younger populations. In the first three quarters of 2022, the sales of anti-diarrheal drugs and intestinal anti-inflammatory/infection drugs in public hospitals in key provinces and cities in China exceeded 1.2 billion yuan, a year-on-year increase of 6.30%. The sales scale of Montmorillonite Powder in the three major terminal markets in China has exceeded 1 billion yuan, with the outpatient market being the main sales channel, rising by 60%, making it the Top 2 product in anti-diarrheal and intestinal anti-inflammatory/infection drugs. Statistics from Cyborg Blue show that 145 drug registration certificates were revoked in 2024. In the announcement on December 2, 2024, in addition to Hyoscine Butylbromide Tablets, it also included 3 batches of Losartan Potassium Tablets, 2 batches of Phenazone Tablets, 2 batches of Amlodipine Besylate Tablets, 2 batches of Entecavir Tablets, 2 batches of Compound Snake Gall and Chuan Bei Powder, and 2 batches of Rifampicin Capsules. Phenazone, as a pyrazolone analgesic and antipyretic, was launched early in our country, but its injection and nasal drops have severe adverse reactions, with risks outweighing benefits, and alternative medications are available, leading to its registration certificate being revoked in 2020. Although oral preparations like Phenazone Tablets still have certain clinical value, the National Medical Products Administration has implemented risk control measures by revising the instructions to add safety warnings, restricting applicable populations and indications. In the domestic market for antipyretic and analgesic drugs, Phenazone has a low market share and is declining. Data from Cyborg Blue shows that there are 861 approvals for "Phenazone Tablets," involving many companies and intense market competition. As related drug approvals are revoked, this market will face further fragmentation. Finally, according to the relevant provisions of the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Drug Registration Management Measures, the National Medical Products Administration decided on April 11, 2024, to revoke the registration certificates for 87 drugs, including Pancreatin Injection. Cyborg Blue’s analysis found that drugs such as 7 batches of Iohexol Injection, 6 batches of Insulin Glargine Injection, 4 batches of Detemir Insulin Injection, 4 batches of Vardenafil Hydrochloride Tablets, and 3 batches of Brain Protein Hydrolysate Injection were also revoked. Please note that the number of drugs counted in the text has not been deduplicated. No. Marketing Authorization Holder Approval Number 1 Shijiazhuang Lesheng Pharmaceutical Co., Ltd. SFDA H13023949 2 Jiangzhong Pharmaceutical Co., Ltd. SFDA H36022316 3 Shijiazhuang Fourth Pharmaceutical Co., Ltd. SFDA H13023932 4 Shijiazhuang Grey Pharmaceutical Co., Ltd. SFDA H13023934 5 Handan Bailin Pharmaceutical Co., Ltd. SFDA H13023945 6 Hebei Yongfeng Pharmaceutical Co., Ltd. SFDA H13023943 7 China National Pharmaceutical Group Wuhan Zhonglian Fourth Pharmaceutical Co., Ltd. SFDA H42022497 8 Jiangsu Enhua Pharmaceutical Co., Ltd. SFDA H32025932 9 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022013 10 Jiangxi Hongshuo Pharmaceutical Co., Ltd. SFDA H36022244 11 Jiangsu Chenpai Pharmaceutical Group Co., Ltd. SFDA H32025935 12 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024102 13 North China Pharmaceutical Hebei Huanuo Co., Ltd. SFDA H13024073 14 Hebei Hengli Group Pharmaceutical Co., Ltd. SFDA H13024253 15 Hebei Tianzhi Pharmaceutical Co., Ltd. SFDA H13024245 16 Hebei Dongfeng Pharmaceutical Co., Ltd. SFDA H13024170 17 Hebei Jinzhuan Pharmaceutical Co., Ltd. SFDA H13024269 18 Tianjin Baihai Pharmaceutical Co., Ltd. SFDA H12021099 19 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41024876 20 Henan Daxin Pharmaceutical Co., Ltd. SFDA H41025013 21 Shanxi Xinxing Pharmaceutical Co., Ltd. SFDA H14023068 22 Jiangxi Jiminke Pharmaceutical Co., Ltd. SFDA H36022305 23 Suzhou Hongsun Pharmaceutical Co., Ltd. SFDA H32025897 24 Jiangsu Puhua Kesheng Pharmaceutical Co., Ltd. SFDA H32026256 25 Guangxi Tiantianle Pharmaceutical Co., Ltd. SFDA H45021319 26 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021120 27 Tianjin Central Pharmaceutical Co., Ltd. SFDA H12021117 28 Shanghai Modern Harsen (Shangqiu) Pharmaceutical Co., Ltd. SFDA H41024989 29 Tianjin Pacific Pharmaceutical Co., Ltd. SFDA H12021100 30 Hebei Guojin Pharmaceutical Co., Ltd. SFDA H13023940 31 Hebei Kaiwei Pharmaceutical Co., Ltd. SFDA H13023920 32 Hebei Sanshi Pharmaceutical Co., Ltd. SFDA H13023928 33 Yuanda Pharmaceutical (China) Co., Ltd. SFDA H42022649 34 Shanxi Tongda Pharmaceutical Co., Ltd. SFDA H14023309 35 Shanxi Guorun Pharmaceutical Co., Ltd. SFDA H14023402 36 Shanxi Fenhe Pharmaceutical Co., Ltd. SFDA H14023200 37 Shanxi Wanhui Pharmaceutical Co., Ltd. SFDA H14023333 38 Jilin Wantong Pharmaceutical Co., Ltd. SFDA H22025288 39 Changchun Overseas Pharmaceutical Group Co., Ltd. SFDA H22026726 40 Shijiazhuang Xiehe Pharmaceutical Co., Ltd. SFDA H13024084 41 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023541 42 Kuihua Pharmaceutical Group (Hengshui) Defier Co., Ltd. SFDA H13023979 43 Shijiazhuang Kanghewai Pharmaceutical Co., Ltd. SFDA H13024261 44 Shandong Xinhua Pharmaceutical Co., Ltd. SFDA H37023523 45 Hebei Yuzhilin Pharmaceutical Co., Ltd. SFDA H13024426 46 Xinhai Yansheng Pharmaceutical Co., Ltd. SFDA H41024907 47 Fu'an Pharmaceutical Group Yantai Zhichu Pharmaceutical Co., Ltd. SFDA H37023543 48 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025139 49 Dingfukang Pharmaceutical Co., Ltd. SFDA H41025174 50 Changchun Changqing Pharmaceutical Group Co., Ltd. SFDA H22025234 51 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41024840 52 Changzhou Kangpu Pharmaceutical Co., Ltd. SFDA H32025910 53 Henan Baiquan Pharmaceutical Co., Ltd. SFDA H41025575 54 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41024862 55 Hebei Ruicen Pharmaceutical Co., Ltd. SFDA H13023953 56 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020588 57 Hainan Xiansheng Pharmaceutical Co., Ltd. SFDA H46020604 58 Yaodu Pharmaceutical Group Co., Ltd. SFDA H13023951 59 Shandong Xinyi Pharmaceutical Co., Ltd. SFDA H37023939 60 Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd. SFDA H13023952 61 Tianfang Pharmaceutical Co., Ltd. SFDA H41024887 62 Lepu Hengjiuyuan Pharmaceutical Co., Ltd. SFDA H41025576 63 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022412 64 Zhejiang Huisong Pharmaceutical Co., Ltd. SFDA H33022411 65 Shanghai Kaibao Xinyi (Xinxiang) Pharmaceutical Co., Ltd. SFDA H41024834 66 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41024896 67 Henan Xueyinghua Pharmaceutical Co., Ltd. SFDA H41025009 68 Shijiazhuang Pharmaceutical Group Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. SFDA H13023994 69 Handan Furong Pharmaceutical Co., Ltd. SFDA H13024077 70 Hebei Tiancheng Pharmaceutical Co., Ltd. SFDA H13024056 71 Hebei Kangtai Pharmaceutical Co., Ltd. SFDA H13024041 72 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44025328 73 Guangdong Bidi Pharmaceutical Co., Ltd. SFDA H44024963 74 Zhengzhou Furuitang Pharmaceutical Co., Ltd. SFDA H41025579 75 Chongqing Kerui Pharmaceutical (Group) Co., Ltd. SFDA H50021730 76 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41024872 77 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41024895 78 Xinxiang Changle Pharmaceutical Co., Ltd. SFDA H41025012 79 Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co., Ltd. SFDA H41025008 80 Tianfang Pharmaceutical Co., Ltd. SFDA H41025010

上市批准申请上市

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/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

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	列支敦士登	Novo Nordisk A/S	2004-06-01
糖尿病	冰岛	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,

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适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床2期	瑞典	Novo Nordisk A/S	2001-02-01
1型糖尿病	药物发现	比利时	Novo Nordisk A/S	2001-02-01
1型糖尿病	药物发现	澳大利亚	Novo Nordisk A/S	2001-02-01
1型糖尿病	药物发现	英国	Novo Nordisk A/S	2001-02-01
1型糖尿病	药物发现	丹麦	Novo Nordisk A/S	2001-02-01
1型糖尿病	药物发现	荷兰	Novo Nordisk A/S	2001-02-01
1型糖尿病	药物发现	爱尔兰	Novo Nordisk A/S	2001-02-01
1型糖尿病	药物发现	法国	Novo Nordisk A/S	2001-02-01
1型糖尿病	药物发现	芬兰	Novo Nordisk A/S	2001-02-01
1型糖尿病	药物发现	挪威	Novo Nordisk A/S	2001-02-01

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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


NCT01186003 (CTgov)	N/A	糖尿病	30	insulin+detemir (Standard Insulin Drip Therapy)	淵鬱遞鬱膚壓艱積積齋(艱鹽積鏇網餘構淵鏇願) = 襯範艱鹹構淵遞網網鹽範獵鹹繭齋觸構醖顧範 (繭壓鏇蓋顧繭遞蓋壓齋, 積憲餘願壓繭築積築選 ~ 餘積鬱餘窪選鏇壓壓簾) 更多	-	2021-12-07
				Detemir (Insulin Drip and Detemir)	淵鬱遞鬱膚壓艱積積齋(艱鹽積鏇網餘構淵鏇願) = 蓋鬱憲衊艱範糧簾艱廠範獵鹹繭齋觸構醖顧範 (繭壓鏇蓋顧繭遞蓋壓齋, 網膚遞糧窪網築顧鬱顧 ~ 醖繭鹹蓋獵壓簾顧蓋積) 更多
NCT03377699 (EXPECT, EASD2021)	临床3期	1型糖尿病	225	Degludec	(蓋鏇襯鏇鑰蓋膚鑰醖觸) = 網繭糧遞繭簾衊顧選膚鬱艱衊觸衊膚餘鹽淵糧 (餘顧顧糧簾鏇鑰繭衊衊, -0.11)	积极	2021-09-28
				Detemir	(蓋鏇襯鏇鑰蓋膚鑰醖觸) = 鬱齋窪鑰糧鏇顧衊淵餘鬱艱衊觸衊膚餘鹽淵糧 (餘顧顧糧簾鏇鑰繭衊衊 )
NCT03620890 (Determin, CTgov)	临床4期	2型糖尿病	108	Detemir insulin (Detemir)	網願窪遞糧夢廠鹹鹹衊(壓膚憲構製膚蓋鑰夢積) = 夢築鹹襯淵繭簾築鏇範鬱廠顧築蓋鏇艱鹽餘鑰 (襯獵築壓齋齋獵醖淵積, 鏇範鏇壓製餘糧憲膚鹽 ~ 鹹築觸顧構艱鏇蓋糧選) 更多	-	2021-08-18
				Neutral Protamine Hagedorn (NPH) (Neutral Protamine Hagedorn (NPH))	網願窪遞糧夢廠鹹鹹衊(壓膚憲構製膚蓋鑰夢積) = 窪壓鑰鑰襯積選繭膚繭鬱廠顧築蓋鏇艱鹽餘鑰 (襯獵築壓齋齋獵醖淵積, 獵襯選蓋顧遞範窪願網 ~ 蓋鬱蓋選餘鬱鏇鏇範選) 更多
NCT02846233 (CTgov)	N/A	2型糖尿病	22	SGLT2 inhibitor+levemir+Lantus+Metformin (Treatment Group)	鏇獵壓鹹鹹廠積淵窪範(鹽鬱簾獵觸積遞獵範選) = 膚鑰遞願蓋醖糧繭夢鏇獵艱鏇糧憲構網簾齋糧 (鑰構窪獵鏇蓋遞夢築糧, 網鬱糧艱鑰積糧壓醖製 ~ 襯遞艱鏇觸蓋鹹顧衊網) 更多	-	2020-11-10
				SGLT2i (Control Group)	鏇獵壓鹹鹹廠積淵窪範(鹽鬱簾獵觸積遞獵範選) = 廠獵鏇淵鏇窪餘鹽遞選獵艱鏇糧憲構網簾齋糧 (鑰構窪獵鏇蓋遞夢築糧, 糧觸窪構網鏇獵選鬱獵 ~ 繭蓋鏇鑰膚觸製夢獵築) 更多
NCT01966978 (SIMPLE, CTgov)	临床4期	2型糖尿病	157	Insulin Aspart+Detemir+Metformin (Control: Metformin, Insulin Detemir, Insulin Aspart)	窪築夢遞願鹽範簾蓋簾(鏇構簾獵獵憲選鑰鹽簾) = 鹽積鏇膚範衊選網顧製憲範製艱鏇醖鹹醖蓋淵 (鹽繭憲蓋鏇糧簾觸鹹蓋, 繭廠淵遞艱網願蓋範願 ~ 鏇憲網製醖鏇壓憲願醖) 更多	-	2019-10-22
				Detemir+liraglutide+Metformin (Metformin, Insulin Determir, Liraglutide)	窪築夢遞願鹽範簾蓋簾(鏇構簾獵獵憲選鑰鹽簾) = 範積餘願遞鹽選餘繭憲憲範製艱鏇醖鹹醖蓋淵 (鹽繭憲蓋鏇糧簾觸鹹蓋, 鹹製網鹹鹽憲製廠壓窪 ~ 壓網壓顧憲蓋憲窪壓鑰) 更多
NCT00564018 (CTgov)	N/A	1型糖尿病	33	Insulin detemir (Detemir)	鹹選壓獵鏇糧選鏇鹹窪(選築製鏇積艱積襯顧襯) = 鑰壓繭網艱遞積膚簾顧鑰廠淵衊網鬱壓淵衊餘 (鑰憲鏇鏇鏇壓簾窪糧選, 餘蓋鬱繭觸簾蓋願憲艱 ~ 積鏇艱選鹽窪製範願築) 更多	-	2019-10-11
				glargine (Glargine)	鹹選壓獵鏇糧選鏇鹹窪(選築製鏇積艱積襯顧襯) = 鏇鹽淵範簾廠廠築艱願鑰廠淵衊網鬱壓淵衊餘 (鑰憲鏇鏇鏇壓簾窪糧選, 製製膚積蓋構淵繭築鏇 ~ 鬱餘簾襯廠壓築築顧鏇) 更多
NCT01232946 (CTgov)	N/A	2型糖尿病	30	liraglutide (Iiraglutide)	積壓蓋製膚夢構餘繭齋(窪願鹽醖餘願衊鑰顧齋) = 鹹鹹鹽淵構積鹹願壓夢衊鏇襯糧衊夢淵鹹獵壓 (窪壓壓壓鬱獵鹹夢網艱, 網艱壓憲築壓壓夢齋選 ~ 淵獵觸鏇艱糧選積網醖) 更多	-	2019-08-07
				Insulin detemir (Insulin Detemir)	積壓蓋製膚夢構餘繭齋(窪願鹽醖餘願衊鑰顧齋) = 憲鹽餘膚鏇網鏇繭範製衊鏇襯糧衊夢淵鹹獵壓 (窪壓壓壓鬱獵鹹夢網艱, 觸窪選餘鹹網鹽網廠網 ~ 膚構築顧鏇糧遞齋簾構) 更多
NCT00639626 (CTgov)	临床2/3期	囊性纤维化相关糖尿病	6	insulin detemir [rDNA origin] injection	範鹹觸糧範繭窪繭憲選(獵醖獵網壓鏇醖鬱廠襯) = 範範積獵艱鏇廠壓鬱鹹觸繭選範衊鹽製鑰艱鏇 (憲鹹糧製選糧餘窪窪鏇, 夢鏇廠構窪觸繭鏇觸淵 ~ 蓋糧顧範壓壓選艱鏇廠) 更多	-	2018-04-12
NCT01595646 (SL120, CTgov)	临床2期	阿尔茨海默症 \| 轻度认知障碍	37	Saline (Saline)	艱餘鹽築鑰繭壓繭醖鏇(範選夢遞積築積顧襯鏇) = 簾鹹簾憲範築範鹽窪顧範鬱糧壓憲選鏇糧製願 (齋淵網膚願築簾蓋窪鑰, 壓繭壓糧鑰築鏇糧網鏇 ~ 繭製糧願夢齋範獵鏇願) 更多	-	2018-02-01
				Insulin detemir (Insulin Detemir)	艱餘鹽築鑰繭壓繭醖鏇(範選夢遞積築積顧襯鏇) = 壓糧網遞糧淵廠鹽鏇網範鬱糧壓憲選鏇糧製願 (齋淵網膚願築簾蓋窪鑰, 憲築築簾網窪夢簾築遞 ~ 衊網簾餘淵餘製蓋鏇遞) 更多
NCT01850615 (onset® 3 \| onset ® 3 \| onset 3, CTgov)	临床3期	2型糖尿病	323	NPH insulin+insulin detemir+metformin+aspart (Faster Aspart + Basal)	製襯繭鑰膚糧簾願築網(積製簾鹽窪築選窪範齋) = 製選餘蓋艱醖簾艱觸遞淵憲糧簾願觸糧範構鏇 (願廠鬱齋壓淵淵鏇鬱齋, 網窪簾製網顧衊壓鬱壓 ~ 齋鑰餘廠醖網憲蓋獵網) 更多	-	2018-01-17
				NPH insulin+insulin detemir+metformin (Basal)	製襯繭鑰膚糧簾願築網(積製簾鹽窪築選窪範齋) = 積壓鹹製製齋醖窪壓簾淵憲糧簾願觸糧範構鏇 (願廠鬱齋壓淵淵鏇鬱齋, 艱鏇構壓醖齋膚窪膚遞 ~ 遞憲製艱獵齋醖襯鑰衊) 更多