A Phase 3, Randomised, Open-label, Cross-over Study to Confirm the Clinical Efficacy and Safety of Dasiglucagon Versus Glucagon for the Treatment of Severe Hypoglycaemia in Asian Adults With Type 1 Diabetes (T1D) Including an Investigation of Dasiglucagon in a Japanese Adolescent Cohort

This study will be looking to confirm the effect of dasiglucagon when compared with glucagon for treating very low sugar levels in Asian adults with T1D and the effect of dasiglucagon in Japanese adolescents with T1D. This study wants to demonstrate that dasiglucagon can raise low blood sugar levels just as well as glucagon. Participants will get dasiglucagon and glucagon. In which treatment order participants get study medicines (dasiglucagon and glucagon) is decided by chance. Dasiglucagon is a new medicine, but doctors can prescribe it in the US as it is approved there. Doctors can prescribe glucagon in multiple countries including Japan as an approved medicine. The study will last for about 17 weeks. Participant cannot be in the study if the study doctor thinks that there are risks for participants health. Women cannot take part if pregnant, breast-feeding, plan to get pregnant, during the study period, or not using adequate contraceptive methods. For man: if participant have sex, participant and his partner must use an adequate birth control method during the study.

开始日期2024-09-10

申办/合作机构

Novo Nordisk A/S

NCT01795235 / Unknown statusN/AIIT

Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones

Glucagon has been used for decades as a test of growth hormone (GH) reserve. The pathway by which GH is stimulated by glucagon is not established. Acyl ghrelin has been shown to increase GH levels and to be stimulated by an increase in adrenergic activity. The proposed study will test the concept that with the fall in blood glucose it is likely that there is a sympathetic discharge which contributes to the increase in acyl ghrelin and indirectly leads to the increase in GH and cortisol.

开始日期2012-12-01

申办/合作机构

University of Virginia

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100 项与人高血糖素 (Novo Nordisk) 相关的临床结果

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100 项与人高血糖素 (Novo Nordisk) 相关的转化医学

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100 项与人高血糖素 (Novo Nordisk) 相关的专利（医药）

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305

项与人高血糖素 (Novo Nordisk) 相关的文献（医药）

2024-07-01·Reproductive sciences (Thousand Oaks, Calif.)

The Efficacy of Ganoderma lucidum Extracts on Treating Endometrial Cancer: A Network Pharmacology Approach

Article

作者: Shi, Min

Abstract:

Ganoderma lucidum (GL) is a prominent medicinal mushroom in traditional Chinese medicine, known for its potent antitumor properties. This study aimed to illustrate the efficacy of GL extracts (GLE) on treating endometrial cancer (EC) and explore the underlying mechanisms via network pharmacology and experimental validation. Network pharmacological analysis was conducted to explore the therapeutic efficacy and mechanisms of GL on EC. In vitro experimental validation was performed on human endometrial cancer cell lines HEC-1-A and KLE. Network pharmacology revealed that key targets of GL against EC were primarily associated with the Rap1 signaling pathway. In in vitro experiments, GLE or GGTI-298 (a GTPase inhibitor) treatment inhibited cell proliferation and migration, promoted cell apoptosis, increased caspase-3 level, and arrested cell cycle in G1 phase in HEC-1-A and KLE cells. GLE increased the protein expression of Rap1-GTP, p-AKT, and p-ERK2 in HEC-1-A and KLE cells. Moreover, GGTI-298 enhanced the effects of GLE on suppressing the malignant progression of EC cells and on activating Rap1 signaling pathway. GLE inhibited the malignant progression of EC cells probably via activating the Rap1 signaling pathway.

2024-07-01·Journal of applied toxicology : JAT

Physiologically based pharmacokinetic modeling for confirming the role of CYP3A1/2 and P‐glycoprotein in detoxification mechanism between glycyrrhizic acid and aconitine in rats

Article

作者: Zou, Bin ; Zhao, Jing ; Jin, Jingyi ; Weng, Fengyi ; Yan, Dongming ; Li, Fengling ; Li, Yue ; Zhang, Shuang ; Xu, Xiaoqing ; Qiu, Furong

Abstract:

Fuzi, an effective common herb, is often combined with Gancao to treat disease in clinical practice with enhancing its efficacy and alleviating its toxicity. The major toxic and bioactive compounds in Fuzi and Gancao are aconitine (AC) and glycyrrhizic acid (GL), respectively. This study aims to elucidate detoxification mechanism between AC and GL from pharmacokinetic perspective using physiologically based pharmacokinetic (PBPK) model. In vitro experiments exhibited that AC was mainly metabolized by CYP3A1/2 in rat liver microsomes and transported by P‐glycoprotein (P‐gp) in Caco‐2 cells. Kinetics assays showed that the Km and Vmax of AC towards CYP3A1/2 were 2.38 μM and 57.3 pmol/min/mg, respectively, whereas that of AC towards P‐gp was 11.26 μM and 147.1 pmol/min/mg, respectively. GL markedly induced the mRNA expressions of CYP3A1/2 and MDR1a/b in rat primary hepatocytes. In vivo studies suggested that the intragastric and intravenous administration of GL significantly reduced systemic exposure of AC by 27% and 33%, respectively. Drug–drug interaction (DDI) model of PBPK predicted that co‐administration of GL would decrease the exposure of AC by 39% and 45% in intragastric and intravenous dosing group, respectively. The consistency between predicted data and observed data confirmed that the upregulation of CYP3A1/2 and P‐gp was the crucial detoxification mechanism between AC and GL. Thus, this study provides a demonstration for elucidating the compatibility mechanisms of herbal formula using PBPK modeling and gives support for the clinical co‐medication of Fuzi and Gancao.

2024-05-01·International journal of biological macromolecules

Interpenetrating nanofibrillar membrane of self-assembled collagen and antimicrobial peptides for enhanced bone regeneration

Article

作者: Dai, Jinhong ; Rahimi, Joseph R ; Wang, Hongning ; Lin, Yifan ; Chew, Hooi Pin ; Hu, Chaoming ; Chen, Wener ; Ye, Zhou ; Fischer, Nicholas G ; Huang, Shengbin ; Sang, Ting ; Aparicio, Conrado ; Kong, Liang

Bone regeneration remains a major clinical challenge, especially when infection necessitates prolonged antibiotic treatment. This study presents a membrane composed of self-assembled and interpenetrating GL13K, an antimicrobial peptide (AMP) derived from a salivary protein, in a collagen membrane for antimicrobial activity and enhanced bone regeneration. Commercially available collagen membranes were immersed in GL13K solution, and self-assembly was initiated by raising the solution pH to synthesize the multifunctional membrane called COL-GL. COL-GL was composed of interpenetrating large collagen fibers and short GL13K nanofibrils, which increased hydrophobicity, reduced biodegradation from collagenase, and stiffened the matrix compared to control collagen membranes. Incorporation of GL13K led to antimicrobial and anti-fouling activity against early oral surface colonizer Streptococcus gordonii while not affecting fibroblast cytocompatibility or pre-osteoblast osteogenic differentiation. GL13K in solution also reduced macrophage inflammatory cytokine expression and increased pro-healing cytokine expression. Bone formation in a rat calvarial model was accelerated at eight weeks with COL-GL compared to the gold-standard collagen membrane based on microcomputed tomography and histology. Interpenetration of GL13K within collagen sidesteps challenges with antimicrobial coatings on bone regeneration scaffolds while increasing bone regeneration. This strength makes COL-GL a promising approach to reduce post-surgical infections and aid bone regeneration in dental and orthopedic applications. STATEMENT OF SIGNIFICANCE: The COL-GL membrane, incorporating the antimicrobial peptide GL13K within a collagen membrane, signifies a noteworthy breakthrough in bone regeneration strategies for dental and orthopedic applications. By integrating self-assembled GL13K nanofibers into the membrane, this study successfully addresses the challenges associated with antimicrobial coatings, exhibiting improved antimicrobial and anti-fouling activity while preserving compatibility with fibroblasts and pre-osteoblasts. The accelerated bone formation observed in a rat calvarial model emphasizes the potential of this innovative approach to minimize post-surgical infections and enhance bone regeneration outcomes. As a promising alternative for future therapeutic interventions, this material tackles the clinical challenges of extended antibiotic treatments and antibiotic resistance in bone regeneration scenarios.

项与人高血糖素 (Novo Nordisk) 相关的新闻（医药）

2024-06-12

·医药观澜

30秒完成鼻喷给药！这款糖尿病新药在中国获批，治疗严重低血糖

▎药明康德内容团队报道今日（6月12日），中国国家药监局（NMPA）官网最新公示信息显示，由礼来公司（Eli Lilly and Company）申报的5.1类新药高血糖素鼻用粉雾剂上市申请已获得批准。根据礼来公司早先新闻稿，该药是一款经过鼻喷给药的高血糖素鼻用粉雾剂（商品名为Baqsimi），本次获批的适应症为用于4岁及以上糖尿病患者严重低血糖治疗。值得注意的是，2023年4月，礼来公司已宣布将Baqsimi的全球权益出售给Amphastar公司，这项交易的总金额高达10.75亿美元。截图来源：NMPA官网公开资料显示，糖尿病患者可能因为接受胰岛素治疗而出现严重低血糖。严重低血糖事件往往被大众所忽视，但若不及时治疗可能导致十分严重的后果，如意识丧失、癫痫发作、昏迷、甚至死亡，以及不可逆的脑损伤和大血管、微血管事件风险增加等长期影响。研究表明，低血糖持续30分钟即发生不可逆的脑损伤。严重低血糖发作的人往往必须接受胰高血糖素注射治疗，而这类注射液使用时操作复杂，需要复溶、排气以及专业的注射技术，并不能满足严重低血糖的现场急救需求。 Baqsimi是一款经鼻喷给药的高血糖素鼻用粉雾剂。据礼来早先发布的公开资料介绍，它采用一次性给药器给药，通过刺激肝脏将储存的葡萄糖释放到血液中，从而增加患者体内的血糖水平。在严重低血糖的紧急救治中，该药物通过患者鼻粘膜被动吸收，无需患者进行吸气配合。同时，给药者无需掌握专业技术，在30秒内即可完成给药，成功率高达90%以上。研究表明，使用高血糖素注射液或Baqsimi均可使严重低血糖患者的血糖水平得到快速、有效提升，但与高血糖素注射液相比，使用Baqsimi的患者继发性高血糖（指给药1小时后血糖超过10mmol/L）发生风险相对更低。且Baqsimi体积小、可室温保存、便于携带、单次给药剂量固定3毫克（无需混悬）。 2019年7月，FDA宣布批准Baqsimi粉剂用于治疗4岁及以上糖尿病患者的严重低血糖症。根据FDA早先新闻稿，这也是其首次批准用于严重低血糖急救的非注射型胰高血糖素疗法。此前，NMPA已批准该药品将依据全球数据及根据真实世界使用研究进行审评，免中国临床试验。 2023年4月，礼来宣布将Baqsimi的全球权益出售给Amphastar公司，后者将在交易完成时向礼来支付5亿美元现金，并在交易完成一周年时再支付1.25亿美元现金。礼来也有资格获得总额高达4.5亿美元的基于销售的里程碑付款。据礼来早先新闻稿介绍，Baqsimi用于严重低血糖治疗的注册申请主要基于针对健康人、1型和2型的成人和儿童青少年糖尿病患者的11项全球研究，共计超500名受试者参与研究，对照药物均为高血糖素注射液。全球成人研究及儿科研究均证实Baqsimi与高血糖素注射液疗效相似，安全性相似，二者治疗成功率（定义为单次给药30分钟内，患者苏醒并恢复至正常状态）均为100%。安全性方面，常见的不良反应主要为已上市的高血糖素类药物常见的恶心、呕吐和头痛等；与给药途径相关的不良反应也均为轻中度和一过性；真实世界使用研究则进一步证实了Baqsimi有效安全且使用便捷，94%的给药者认为使用非常方便，未出现严重不良反应。全球数据表明，无论1型糖尿病或者2型糖尿病患者，约87%的严重低血糖事件发生在家中。而有统计数据表明，在中国发生严重低血糖的患者得到救助的时长平均需要2.6小时，患者得到救助时血糖水平低，血糖平均仅1.6mmol/L，院外现场急救成功率仅29.7%。由此可见，现有治疗手段未能充分满足严重低血糖的现场急救需求。希望这款高血糖素鼻用粉雾剂尽快来到患者身边，使更多的患者能通过简易的鼻喷给药方式，在严重低血糖事件中进行及时、便捷的现场施救。参考资料： [1] 2024年06月12日药品批准证明文件送达信息.Retrieved June 12， 2024, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240612124002121.html [2]礼来Baqsimi®的(高血糖素鼻用粉雾剂)在中国递交注册申请. Retrieved Aug 2, 2022, from https://mp.weixin.qq.com/s/_OytfC_TxMN1wATY4roJrg [3]FDA approves first treatment for severe hypoglycemia that can be administered without an injection. Retrieved July 24, 2019, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-severe-hypoglycemia-can-be-administered-without-injection?utm_campaign=07242019_PR_FDA%20approves%20nasal%20powder%20glucagon%20hypoglycemia%20treatment&utm_medium=email&utm_source=Eloqua [4]Lilly to Divest BAQSIMI to Amphastar. Retrieved Apr 24, 2023, from https://investor.lilly.com/news-releases/news-release-details/lilly-divest-baqsimi-amphastar 本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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。

引进/卖出申请上市免疫疗法上市批准

2023-04-25

·药时代

礼来剥离一款糖尿病产品，以10.75亿美元价格售出

交易，讲究各取所需。2023年4月24日，礼来宣布将旗下鼻喷胰高血糖素激动剂Baqsimi的全球权益出售给美国制药公司Amphastar。根据协议，礼来将一次性获得5亿美元的首付款，交易完成1年后获得1.25亿美元现金以及最高4.5亿美元的销售额里程碑付款，交易总金额高达10.75亿美元。Baqsimi是一款用于治疗4岁以上糖尿病患者发生极低血糖的药物，2019年在欧盟获批上市，目前在27个国家有售。2022年8月1日，礼来已经在中国递交了该产品的上市申请。2022年Baqsimi的全年销售额为1.393亿美元。作为糖尿病巨头，糖尿病管线产品丰富对礼来本是一件好事，但Baqsimi却不太一样，它的适应症限制了其用药场景。常规糖尿病产品是以控糖、降糖为主，要么是日常服用，要么是随餐使用。但Baqsimi却是一款升糖产品，用以应对糖尿病患者发生严重低血糖时的场景。一般低血糖都用不到它，吃个糖、巧克力就好了，得是昏迷、癫痫、意识丧失等情况，因为Baqsimi在给药后通过患者鼻粘膜被动吸收，无需患者进行吸气配合。这种特殊的用药场景，使其更倾向于是一款急救药，适合在急救科使用。对礼来的糖尿病团队来说，不仅没有增加管线的丰度，反而分担了精力。目前礼来正与诺和诺德在代谢领域一争高下，虽然Baqsimi是目前全球唯一获批的鼻喷高血糖素，是一款优质产品，但如果礼来抽不出身来好好经营，就会显得颇为鸡肋。Amphastar恰好是一个能好好经营这款产品的公司。Amphastar成立于1996年，专注于开发注射、鼻喷和吸入式产品。不按适应症，而是按制剂类型给公司定位，有点别具一格。在Baqsimi之前，常用的严重低血糖急救产品是胰高血糖素注射剂，恰好，是Amphastar的旗下产品。渠道、领域都很合适。Baqsimi出现之后对Amphastar的胰高血糖素注射剂产生了比较大的打击。所以，既然打不过，那就买下来。唯一的问题可能就是，Amphastar在全球范围内的渠道可能并没有礼来多，所以他们有可能在未来的销售推广过程中，将Baqsimi的部分权益拆零卖出。Amphastar在中国的分公司叫美药星（南京）制药有限公司，是一家集药品研发、生产、销售于一体的高科技医药研发生产企业，共有员工400余人。400多人，做一款普药应该是不够的，所以当Baqsimi在中国上市后，是否会有新的交易诞生呢？参考资料:https://endpts.com/lilly-to-divest-diabetes-rescue-treatment-baqsimi-for-500m-to-amphastar/Amphastar官网https://www.baqsimi.com/what-is-baqsimi#about-baqsimi美药星（南京）制药有限公司其他公开资料亲爱的读者，您好！感谢您一直以来对药时代的支持和关注，我们非常珍惜你的每一次阅读和反馈。为了能够更好地了解你的喜好和需求，提供更优质的内容和服务，我们特别设计了一份调研问卷，希望您能抽出几分钟的时间填写一下。您的意见和建议对药时代非常重要，也将帮助我们不断进步和改进。请点击下方小程序卡片进入问卷页面，填写完成后，点击抽奖按钮，即有机会抽取由药时代准备的1more蓝牙耳机一份（价值399元）！感谢您的参与和配合，祝您生活愉快！点击在看，共济新药研发浪潮

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