The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. Safety parameters and pharmacodynamics are compared between Dasiglucagon and GlucaGen®.
This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects. The subjects will be randomized to receive either dasiglucagon or GlucaGen® for the first three day study period and switch to the alternate treatment after a wash-out treatment.

开始日期2023-12-29

申办/合作机构

Inreda Diabetic BV

NCT05378672 / Recruiting临床3期

A Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes

This research study will investigate whether dasiglucagon as a rescue therapy for participants between 1 and 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.).
Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

开始日期2023-05-09

申办/合作机构

Zealand Pharma US, Inc.

NCT04824872 / Withdrawn临床2期

A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults

The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects

开始日期2023-02-01

申办/合作机构

Zealand Pharma US, Inc.

100 项与达西格列酮相关的临床结果

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100 项与达西格列酮相关的转化医学

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100 项与达西格列酮相关的专利（医药）

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项与达西格列酮相关的文献（医药）

2024-03-15·The Journal of clinical endocrinology and metabolism

Dasiglucagon for the Treatment of Congenital Hyperinsulinism: A Randomized Phase 3 Trial in Infants and Children

Article

作者: Empting, Susann ; Kendall, David M ; De Leon, Diva D ; Zangen, David ; Ivkovic, Jelena ; Banerjee, Indraneel ; Thornton, Paul S ; Birch, Sune ; Bøge, Eva

Abstract:

Context:

Congenital hyperinsulinism (CHI) is characterized by dysregulated insulin secretion causing hypoglycemia and consequent brain damage. Dasiglucagon is a glucagon analogue under investigation to treat CHI.

Objective:

To evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycemia as add-on to standard of care (SoC).

Methods:

In this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/h) for 4 weeks. In the following 4 weeks, all patients received dasiglucagon + SoC. Hypoglycemia was assessed by self-monitored plasma glucose (SMPG) and blinded continuous glucose monitoring (CGM). Primary endpoint was average number of SMPG-detected hypoglycemia episodes/week (SMPG <3.9 mmol/L) during Weeks 2 to 4.

Results:

Thirty-two patients (0.6-10.9 years) were randomly assigned to dasiglucagon + SoC (n = 16) or SoC (n = 16). The rate of SMPG-detected hypoglycemia decreased from baseline in both groups, but with no statistically significant difference during Weeks 2 to 4 (event rate ratio: 0.85 [0.54; 1.36], P = .5028). However, dasiglucagon administration resulted in a 43% reduction in CGM-detected hypoglycemia (<3.9 mmol/L) vs SoC alone during Weeks 2 to 4 (post hoc analysis; event rate ratio: 0.57 [0.39; 0.83], P = .0029). Dasiglucagon enabled reductions (of 37% to 61%) in all other measures of hypoglycemia assessed by CGM vs SoC alone including extent and percent time in hypoglycemia (post hoc analyses). Dasiglucagon appeared safe and well tolerated. Skin and gastrointestinal events were more frequent with dasiglucagon + SoC than SoC only.

Conclusion:

Clinically meaningful reductions in all CGM-recorded measures of hypoglycemia support using dasiglucagon as a potential treatment for CHI.

2024-01-01·Hormone research in paediatrics

Novel Use of Dasiglucagon, a Soluble Glucagon Analog, for the Treatment of Hyperinsulinemic Hypoglycemia Secondary to Suspected Insulinoma: A Case Report

作者: Mitteer, Lauren M ; De Leon, Diva D ; Reynolds, Dana ; McKnight, Heather ; Bhatti, Tricia ; Becker, Susan ; Lord, Katherine ; Adzick, N Scott ; Sigal, Winifred ; States, Lisa ; Boyajian, Linda

Introduction: Hyperinsulinemic hypoglycemia is the most common cause of persistent hypoglycemia in children and adults. In adolescents and adults, hyperinsulinemic hypoglycemia is most frequently caused by an insulin-producing tumor. Case Presentation: A 17-year-old, previously healthy male presented with recurrent and severe episodes of hypoglycemia. Diagnostic evaluation was consistent with hyperinsulinemic hypoglycemia, and an insulinoma was suspected. Multiple imaging studies and surgical exploration failed to identify a lesion. Over the course of months, the patient was found to be refractory to conventional medical interventions. Conclusion: Upon approval from the US Food and Drug Administration and the Institutional Review Board, the patient was treated with dasiglucagon, a novel soluble glucagon analog, under a single-patient Investigational New Drug. The patient has tolerated the medication and has been able to achieve appropriate glycemic control.

2023-12-01·Diabetes care

Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass: A Randomized, Double-Blind, Placebo-Controlled Trial

Article

作者: Knop, Filip K ; Vilsbøll, Tina ; Houji, Inas J K ; Helsted, Mads M ; Krogh, Liva S L ; Hartmann, Bolette ; Øhrstrøm, Caroline C ; Johansen, Nicklas J ; Nielsen, Casper K ; Holst, Jens J

OBJECTIVE:

Postbariatric hypoglycemia affects >50% of individuals who have undergone Roux-en-Y gastric bypass surgery. Despite the often debilitating nature of this complication, existing treatment options are limited and often inefficient. Dasiglucagon is a stable glucagon analog available in a ready-to-use formulation and was recently shown to mitigate postbariatric hypoglycemia in experimental settings. Here, we aimed to evaluate the hypoglycemic hindering potential of dasiglucagon in an outpatient trial.

RESEARCH DESIGN AND METHODS:

We conducted a randomized, double-blind, placebo-controlled, crossover, proof-of-concept study at the Center for Clinical Metabolic Research at Gentofte Hospital in Denmark. The study included 24 individuals who had undergone Roux-en-Y gastric bypass surgery (n = 23 women) with continuous glucose monitor–verified postbariatric hypoglycemia (≥15 min at <3.9 mmol/L three or more times per week) randomly assigned to two treatment periods of 4 weeks of self-administered subcutaneous dasiglucagon at 120 μg or placebo. The primary and key secondary outcomes were continuous glucose monitor–captured percentage of time in level 1 and 2 hypoglycemia (<3.9 and <3.0 mmol/L), respectively.

RESULTS:

Compared with placebo, treatment with dasiglucagon significantly reduced time in level 1 hypoglycemia by 33% (−1.2 percentage points; 95% CI −2.0 to −0.5; P = 0.002) and time in level 2 hypoglycemia by 54% (−0.4 percentage points; 95% CI −0.6 to −0.2; P < 0.0001). Furthermore, dasiglucagon corrected hypoglycemia within 15 min in 401 of 412 self-administrations, compared with 104 of 357 placebo self-administrations (97.3% vs. 29.1% correction of hypoglycemia rate; P < 0.001). Dasiglucagon was generally well tolerated, with mostly mild to moderate adverse events of nausea.

CONCLUSIONS:

Compared with placebo, 4 weeks of self-administered dasiglucagon effectively reduced clinically relevant hypoglycemia in individuals who had undergone Roux-en-Y gastric bypass surgery.

项与达西格列酮相关的新闻（医药）

2024-06-03

·GlobeNewswire-Health Care

Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency

Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency May 31, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for dasiglucagon solution for injection in the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus. "We are very pleased that the European regulatory authorities have recommended approval of dasiglucagon as a rescue treatment for very low blood sugar in people with diabetes," said Adam Steensberg, Chief Executive Officer of Zealand Pharma. "This is an important step in achieving our ambition of bringing this product to many more patients around the world through our partnership with Novo Nordisk, a global leader in diabetes." The positive opinion from the CHMP will be referred to the European Commission (EC) for a final decision whether to grant marketing authorization in the European Union (EU). Zealand expects this decision within approximately three months. Dasiglucagon injection was approved by the U.S. FDA in March 2021 under the brand name Zegalogue®. Dasiglucagon injection was approved under the brand name Zegalogue® by the U.S. FDA on March 22, 2021, for the treatment of severe hypoglycemia in pediatric and adult people with diabetes aged 6 years and above. Zegalogue® is available in the U.S. in both an autoinjector and a prefilled syringe. The U.S. approval was based on results from three pivotal trials in adults and children with diabetes, showing a median time to blood glucose recovery from severe hypoglycemia of 10 minutes following injection of 0.6 mg/0.6 mL of dasiglucagon. In these Phase 3 trials, the most common adverse events reported (≥2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults; and nausea, vomiting, headache and injection site pain in pediatric patients. In September 2022, Zealand entered into a global license and development agreement with Novo Nordisk A/S to commercialize Zegalogue®. Under the terms of the agreement, Zealand is eligible to receive up to DKK 265 million in development, regulatory, manufacturing and sales-based milestones, as well as tiered royalties ranging from high single-digit to low double-digit percentages on worldwide net sales of Zegalogue® to be marketed by Novo Nordisk. Zealand is responsible for certain planned regulatory, development and manufacturing activities, including the Marketing Authorization Application (MAA) to the EMA, to support further development and approval outside of the U.S. Zealand retains all non-licensed intellectual property rights to the company’s other dasiglucagon development programs. Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand’s business and activities, please visit www.zealandpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

上市批准引进/卖出

2024-05-31

·Firstwordpharma

CHMP nods for haemophilia B gene therapy, chikungunya vaccine lead decisions from May meeting

At its May meeting, the European Medicines Agency's drug advisory body recommended 14 new medicines for approval, including one biosimilar and five generics, while it also backed extended labelling for seven treatments. In addition, the Committee for Medicinal Products for Human Use (CHMP) confirmed a negative opinion following a re-examination, and there were two marketing application withdrawals. All of the decisions can be found detailed below.Positive recommendations on new medicines: Takeda’s enzyme replacement therapy Adzynma (rADAMTS13) for the treatment of children and adult patients with congenital thrombotic thrombocytopenic purpura. SIFI’s Akantior (polyhexanide) for the treatment of acanthamoeba keratitis. CStone Pharmaceuticals’ anti-PD-L1 monoclonal antibody Cejemly (sugemalimab) for the treatment of adults with metastatic non-small-cell lung cancer (NSCLC). Pfizer’s gene therapy Durveqtix (fidanacogene elaparvovec) for the treatment of haemophilia B. AstraZeneca’s Fluenz (influenza vaccine [live attenuated, nasal]) for the prophylaxis of influenza in children and adolescents from 24 months to <18 years of age. Eckert & Ziegler’s GalliaPharm (germanium [68Ge] chloride / gallium [68Ga] chloride) for radiolabelling of various kits used for positron emission tomography (PET) imaging. Valneva’s Ixchiq (chikungunya vaccine [live]) to protect adults against disease caused by Chikungunya virus transmitted to humans by infected mosquitoes. Novo Nordisk’s Zegalogue (dasiglucagon) for the treatment of severe hypoglycaemia in adults, adolescents and children aged six years and over with diabetes mellitus. Bio-Thera Solutions’ biosimilar version of Avastin (bevacizumab), named Avzivi, for the treatment of carcinoma of the colon or rectum, breast cancer, NSCLC, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. Five generic medicines also received a positive opinion: Apexelsin (paclitaxel) for the treatment of metastatic breast cancer; Dasatinib Accord Healthcare (dasatinib) for the treatment of chronic myelogenous leukaemia; and generic versions of pomalidomide from Accord Healthcare, Krka and Zentiva for treatment of multiple myeloma.Positive recommendations on extensions of therapeutic indication: Sanofi/Regeneron’s Dupixent (dupilumab) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils. Bristol Myers Squibb/Pfizer’s Eliquis (apixaban) to include the treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to <18 years of age. Calliditas Therapeutics/Stada’s Kinpeygo (budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). Mirum Pharmaceuticals’ Livmarli (maralixibat) to include progressive familial intrahepatic cholestasis in patients 3 months of age and older. AbbVie’s Skyrizi (risankizumab) for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. AstraZeneca’s Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. BeiGene’s Tevimbra (tislelizumab) alone for the treatment of adults with locally advanced or metastatic NSCLC after prior platinum-based therapy; in combination with pemetrexed and platinum‑containing chemotherapy for the first-line treatment of certain adults with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations; and in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of certain adults with squamous NSCLC.Negative opinions on new medicines: The CHMP confirmed its initial recommendation to refuse the granting of a marketing authorisation for Neuraxpharm and Minoryx Therapeutics’ Nezglyal (leriglitazone) for the treatment of cerebral adrenoleukodystrophy.Withdrawal of applications: Cytokinetics pulled a filing seeking approval of Kinharto (omecamtiv mecarbil) for the treatment of adults with symptomatic chronic heart failure and reduced ejection fraction. The decision was based on feedback from the EMA that supporting results were not sufficient to conclude that the benefits of the cardiac myosin activator outweigh the risks. Cytokinetics recently outlined plans to conduct another study of Kinharto. Clinuvel withdrew an application to expand use of Scenesse (afamelanotide) into adolescents with erythropoietic protoporphyria. The drug has been approved in this indication in the EU since 2014 for adults. However, the company determined that it was not possible to provide the comprehensive safety and efficacy data expected by the EMA in the expanded population.

上市批准疫苗临床结果

2024-05-27

·药时代

12周仅减重4.3%！GLP-1/GLP-2双靶点能否走通？

5月25日，Zealand Pharma公布了旗下GLP-1/GLP-2受体双重激动剂dapiglutide用于减重的12周数据。该研究是一项单中心II期概念验证临床试验，拟入组54例18~75岁体重指数（BMI）≥30kg/m2的肥胖症患者，旨在评估每周一次dapiglutide的减重效果。入组患者将被分为4个队列：4mg治疗组、6mg治疗组、4mg安慰剂组与6mg安慰剂组，研究的主要终点为第12周患者的体重变化百分比。结果显示，在54名肥胖患者中，4mg与6mg治疗组较基线平均体重减轻变化分别为2.9%（p=0.483）和4.3%（p=0.077），而安慰剂组这一数值为2.2%。12周，仅4%左右的减重效果，无法使投资人满意。消息一经披露，Zealand股价跌近3%。对此Zealand表示，虽然疗效有限，但安全性好，不良事件发生率低，目前我们正在评估dapiglutide 13mg剂量组的可及性，预计将在下半年公布主要结果。dapiglutide是一款非常有意思的“FIC”，其靶向的GLP-1与GLP-2都源于相同的前体蛋白质——前胰高血糖素原，但两个的功能却大相径庭。GLP-1主要参与葡萄糖稳态的调节，通过增加胰岛素分泌、减少胰高血糖素分泌、延缓胃排空和降低食欲来达到降低血糖和减轻体重的效果。GLP-2则主要作用于肠道，促进营养物质吸收、增加肠道的血液供应和促进肠道细胞的增殖，功能为改善肠道屏障功能，减少炎症反应。两者对血糖的影响正好完全相反，那用于减重，两者是否也会相互影响？考虑到GLP-2在改善肠道完整性方面的作用可能对整体代谢有益，双方在人体内可协同工作，做到即要减重，又要保护肠道，提高安全性的同时，达到更全面的代谢改善。想法不错，可12周4%左右的减重效果，确实毫无市场竞争力。诺和诺德的口服GLP-1受体和胰淀素受体的长效共激动剂amycretin，在1期临床中，受试者 12 周后体重下降了 13.1%，而安慰组仅下降了 1.1%。Viking的口服GLP-1/GIP双重激动剂VK2735在治疗13周时，15mg剂量组体重下降了14.7%，而安慰组仅为下降了1.7%。更优的疗效，还是口服剂型，Zealand又当如何应对？希望后续13mg剂量组可以给同行们带来一点点震撼。当然，dapiglutide的核心竞争力，应该是独特的机制下，带来的更优安全性与胃肠道保护。毕竟长期用药，安全性不容小觑。Zealand成立于1998年，总部位于丹麦哥本哈根，与诺和诺德比邻而居，两者相距仅几英里。与老邻居一样，Zealand最初也做“降糖”，旗下首个上市产品就是GLP-1受体激动剂——利西拉来，2003年便将其授权给了赛诺菲。2021年旗下新型人胰高血糖素类似物Dasiglucagon在美上市，用于治疗6岁及以上糖尿病患者的严重低血糖，为此Zealand还开发了自动注射器HypoPal以便患者自我给药，可在室温储存。可上市后产品业绩表现不佳，看着老邻居GLP-1卖的大热，“一气之下”，Zealand决定改变经营战略，专注于肥胖药物的研发。2022年3月，Zealand宣布在美国的办事处裁员90%，并削减至少35%的年度运营费用，换下CEO。同年6月，Zealand与老邻居诺和诺德就Dasiglucagon达成合作，将该药的全球商业化交给了后者负责。自此，Zealand的命运开始发生了改变。2023年一年，Zealand的股价涨幅为75%，超过了老邻居诺和诺德的54.83%与礼来的60.91%。其中，Zealand与BI共同开发的GCG/GLP-1双受体激动剂Survodutide，为投资人提供了极大的想象空间。去年6月，这两家公司报告的II期数据显示，在不伴有2型糖尿病的肥胖患者中，4.8mg剂量的survodutide在46周后实现了近19%的体重减轻。今年2月，两家公司又宣布survodutide在治疗MASH的2期临床试验中取得积极结果，在接受治疗48周后，相比安慰剂（18.2%），高达83%接受survodutide治疗的MASH成人患者取得了具有统计学意义的改善（p＜0.0001）。截止2024年第一季度，Zealand已实现了85%的股价涨幅。如此看来，仅3%的股价变动对于Zealand无足轻重。可GLP-1/GLP-2双靶点的机制能否可行，对业内是否具有借鉴意义，这点很重要。目前，基于GLP-1的研发炙手可热，像GLP-1/GCG、GLP-1/GIP、GLP-1/GCG/GIP，口服剂型，都有药企扎堆开发。而GLP-2主要开发的适应症为短肠综合症（罕见病）和胃肠道疾病，相关研究较少，据智慧芽统计，目前全球靶向 GLP-2R 的新药管线仅有 22个。今年2月，Ironwood Pharmaceuticals还因为旗下GLP-2类似物Apraglutide在用于短肠综合征（SBS）的治疗上，未达次要终点，股价暴跌40%。而这款Apraglutide这是Ironwood斥资10亿美元的并购得来。如果GLP-1/GLP-2双靶点的机制可行，那么对相关药企是一次转型的机会，也是国内药企抢差异化的好机会。参考资料：1.Zealand官网2.GLP-1/GLP-2双重受体激动剂仅减重4.3%（大药时记）3.当一家Biotech“叫板”减肥巨头（同写意）4.其他公开资料封面图来源：pixabay版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn「周制剂」降糖时代，GLP-1仍有“盲区”一款药物撑起4笔BD，三个经手药企均被并购！2.25亿美元背后，不容忽视的自免风潮点击阅读原文，了解更多！

临床结果临床2期临床1期

100 项与达西格列酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11359	-	A10BX	DB15226

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
低血糖	美国	Zealand Pharma US, Inc.	2021-03-22

未上市

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适应症	最高研发状态	国家/地区	公司	日期
先天性高胰岛素血症	申请上市	美国	Zealand Pharma A/S	2023-06-30
1型糖尿病	临床3期	美国	Zealand Pharma US, Inc.	2017-06-28
1型糖尿病	临床3期	奥地利	Zealand Pharma US, Inc.	2017-06-28
1型糖尿病	临床3期	加拿大	Zealand Pharma US, Inc.	2017-06-28
1型糖尿病	临床3期	德国	Zealand Pharma US, Inc.	2017-06-28
通气过度	临床1期	德国	Zealand Pharma US, Inc.	2014-12-01

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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


EASD2023	N/A	低血糖	24	Dasiglucagon 120 µg	網淵襯鹽鏇壓餘艱顧鏇(醖範積鹹糧遞獵選衊觸): P-Value = 0.002 更多	积极	2023-10-04
				Placebo
NCT03777176 \| NCT04172441 (Biospace) 人工标引	临床3期	先天性高胰岛素血症	44	Dasiglucagon (NCT04172441)	壓網選簾憲簾夢醖鑰鹹(壓襯襯夢窪襯顧積簾廠) = Skin reactions and gastrointestinal disturbances 醖鏇窪廠積窪鏇鹹觸顧 (壓鬱艱鏇糧遞網窪淵網 ) 更多	积极	2023-08-30
				Dasiglucagon (NCT03777176)
NCT04764968 (Pubmed)	临床2期	低血糖 \| 1型糖尿病	24	Dasiglucagon intervention (DASI)	廠襯鑰構夢鏇選夢遞願(醖築壓齋膚網築廠廠簾) = Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect 鹹構膚壓窪製網願顧窪 (餘選網廠鹹糧鑰鏇襯襯 )	-	2023-04-11
NCT04172441 (ESPE2022) 人工标引	临床2/3期	先天性高胰岛素血症	12	Dasiglucagon	繭壓襯夢糧網窪糧簾憲(鹽醖膚繭簾艱積顧艱構) = 餘鹹遞構獵蓋鑰艱構衊構簾鬱鹽醖製積簾夢範 (蓋糧築鑰製網鏇鏇襯壓 )	积极	2022-09-15
				Placebo	-
NCT04172441 (ESPE2022) 人工标引	临床2/3期	先天性高胰岛素血症	12	Dasiglucagon	餘鑰醖夢衊鏇餘淵選鹹(鑰鬱餘鏇膚築獵淵糧壓) = 範構鹽顧築鹽膚鏇壓衊醖製網構廠願憲繭憲選 (鬱鑰範膚襯餘廠壓鏇鬱, 4.9)	积极	2022-09-15
				Placebo	餘鑰醖夢衊鏇餘淵選鹹(鑰鬱餘鏇膚築獵淵糧壓) = 襯壓艱繭範遞齋醖衊鬱醖製網構廠願憲繭憲選 (鬱鑰範膚襯餘廠壓鏇鬱, 5.6)
ADA2022	N/A	低血糖 \| 1型糖尿病	-	Dasiglucagon (Usual Care)	簾醖範顧獵壓壓製壓蓋(糧網壓獵糧築蓋衊觸餘) = Dasiglucagon use was safe and well tolerated with nausea being the most frequent adverse effect (no. of participants: UC: 4, DASI: 8) 衊壓簾齋鹹衊範製糧繭 (構餘積鹽鏇壓築鹹網蓋 )	-	2022-06-01
				Dasiglucagon
NCT04172441 (GlobeNewswire) 人工标引	临床3期	先天性高胰岛素血症	12	Dasiglucagon	齋廠窪網獵膚觸鏇憲繭(範窪獵願廠蓋觸範憲獵) = 夢醖憲醖製衊鑰簾積醖艱鹽選鹹獵構獵糧襯範 (積願簾獵鏇範淵選繭遞 )	积极	2022-05-19
				Placebo	齋廠窪網獵膚觸鏇憲繭(範窪獵願廠蓋觸範憲獵) = 鹹鹽齋簾衊鏇顧夢簾顧艱鹽選鹹獵構獵糧襯範 (積願簾獵鏇範淵選繭遞 )
NCT04449692 (Pubmed)	临床2期	1型糖尿病	20	Oral glucose (CHO)	衊繭鑰繭遞鏇鑰淵積顧(艱顧構窪夢繭廠鑰鏇鬱) = Episodes of nausea were numerically, but not significantly, higher after dasiglucagon administration. 膚憲觸繭鏇鹹構襯艱淵 (構窪膚繭襯膚製遞築繭 ) 更多	积极	2022-04-27
				Dasiglucagon 80 µg (D80)
NCT03688711 (Pubmed) 人工标引	临床3期	低血糖	45	Dasiglucagon	醖壓醖網築獵壓廠鏇範(鹽膚蓋鏇顧鹽製簾簾範) = 鑰鑰餘遞襯餘醖製鹹構壓選遞襯鏇遞襯鏇願構 (鹹蓋選鹹鹹蓋齋鑰淵鬱, 8.0 ~ 12.0) 更多	积极	2021-10-01
				Placebo	醖壓醖網築獵壓廠鏇範(鹽膚蓋鏇顧鹽製簾簾範) = 積築積遞艱積願壓製製壓選遞襯鏇遞襯鏇願構 (鹹蓋選鹹鹹蓋齋鑰淵鬱, 20.0 ~ NR) 更多
NCT03688711 \| NCT02660008 \| NCT03378635 \| NCT03216226 (EASD2021)	临床2/3期	低血糖	220	Dasiglucagon 0.6 mg	繭願廠製壓壓蓋齋夢觸(壓鬱襯鏇獵積遞網簾廠) = 願廠蓋夢膚窪築壓願製觸顧鬱艱鏇鏇膚鏇繭築 (鬱餘艱餘觸繭壓網窪淵 )	积极	2021-09-30