This is a randomised, double-blind, three-period crossover euglycaemic clamp trial comparing pharmacokinetics and pharmacodynamics of BC Combo THDB0207 and Lantus® and Humalog® in subjects with type 1 diabetes.
Each subject will be randomly allocated to one of the 6 treatment sequences and will be administered single subcutaneous doses of BC Combo THDB0207, Lantus®, and Humalog® at three separate dosing visits.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 24-hour clamp procedures have been terminated. Patients will return to the clinical trial centre for outpatient blood sampling visits for analysis of BC449 excipient until 144 hours after each dosing.

开始日期2022-05-12

申办/合作机构

Adocia SA

[+1]

NCT05373212 / Completed临床1期

A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes

This is a randomised, double-blind, four-period crossover euglycaemic clamp trial in subjects with type 2 diabetes.
Each subject will be randomly allocated to one of four treatment sequences. Each sequence will comprise 3 different single doses of BC Combo THDB0207 (Low dose, Medium dose, and High dose) and one single dose of Humalog® Mix25.
Subjects will come to the clinical trial centre in a fasted state in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

开始日期2022-05-12

申办/合作机构

Adocia SA

[+1]

NCT05373186 / Completed临床1期

A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers

This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers.
Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or simultaneous administration of Humalog® and Lantus®.
Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

开始日期2022-05-12

申办/合作机构

Adocia SA

[+1]

100 项与赖脯胰岛素/甘精胰岛素(Adocia SA) 相关的临床结果

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100 项与赖脯胰岛素/甘精胰岛素(Adocia SA) 相关的转化医学

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100 项与赖脯胰岛素/甘精胰岛素(Adocia SA) 相关的专利（医药）

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项与赖脯胰岛素/甘精胰岛素(Adocia SA) 相关的文献（医药）

2019-07-01·Diabetes, Obesity and Metabolism2区 · 医学

Better glycaemic control with BioChaperone glargine lispro co‐formulation than with insulin lispro Mix25 or separate glargine and lispro administrations after a test meal in people with type 2 diabetes

2区 · 医学

Article

作者: Plum‐Mörschel, Leona ; Anastassiadis, Ernestos ; Meiffren, Grégory ; Klein, Oliver ; Mégret, Claire ; Herbrand, Theresa ; DeVries, J. Hans ; Alluis, Bertrand ; Heise, Tim ; Gaudier, Martin ; Soula, Olivier

Because of its physico‐chemical properties, insulin glargine is usually not mixable with rapid insulins. BioChaperone BC147 is a polyanionic amphiphilic polymer, solubilizing insulin glargine at neutral pH, and thus enabling stable glargine formulation with fast‐acting insulin lispro (BioChaperone glargine lispro co‐formulation [BC Combo]). We investigated pharmacokinetic (PK) endpoints and postprandial glucose (PPG) control after administration of BC Combo (75% insulin glargine, 25% insulin lispro), insulin lispro Mix25 (LMix) and separate injections of insulins glargine (75% total dose) and lispro (25% total dose [G + L]) immediately before ingestion of a mixed meal in people with type 2 diabetes mellitus (T2DM), using a randomized, double‐blind, double‐dummy crossover study design. Participants received individualized bolus doses (mean 0.62 U/kg) of BC Combo, LMix or G + L, together with a solid mixed meal (610 kcal, 50% carbohydrate, 30% fat, 20% protein). Insulin dosages were kept constant for each study day. Thirty‐nine participants with T2DM (mean ± SD age and glycated haemoglobin 60.8 ± 7.5 years and 64 ± 6 mmol/mol, respectively) were randomized. BC Combo improved the predefined primary endpoint, early PPG control, compared to LMix (incremental area under the blood glucose concentration–time curve from 0 to 2 hours after the meal [ΔAUCBG,0–2h] reduction of 18%; P = 0.0009) and G + L (ΔAUCBG,0–2h reduction of 10%; P = 0.0450). The number of mealtime hypoglycaemic episodes per participant was lower with BC Combo (22 episodes in 14 participants) compared to LMix (43 episodes in 20 participants; P = 0.0028), but not significantly different from G + L (28 episodes in 19 participants; P = 0.2523). BC Combo demonstrated superior early PPG control with fewer hypoglycaemic episodes compared to LMix and superior early PPG control compared to separate G + L administrations.

2019-06-01·Genomics, Proteomics & Bioinformatics1区 · 生物学

Diversified Application of Barcoded PLATO (PLATO-BC) Platform for Identification of Protein Interactions

1区 · 生物学

ArticleOA

作者: Qi, Jun ; Que, Jianwen ; Zhu, Jian ; Fiches, Guillaume ; Liu, Shuai ; Hayashi, Tsuyoshi ; Elledge, Stephen J ; Xu, Qikai ; Kong, Weili ; Li, Mamie Z ; Santoso, Netty ; Zhang, Wei

AbstractProteins usually associate with other molecules physically to execute their functions. Identifying these interactions is important for the functional analysis of proteins. Previously, we reported the parallel analysis of translated ORFs (PLATO) to couple ribosome display of full-length ORFs with affinity enrichment of mRNA/protein/ribosome complexes for the “bait” molecules, followed by the deep sequencing analysis of mRNA. However, the sample processing, from extraction of precipitated mRNA to generation of DNA libraries, includes numerous steps, which is tedious and may cause the loss of materials. Barcoded PLATO (PLATO-BC), an improved platform was further developed to test its application for protein interaction discovery. In this report, we tested the antisera-antigen interaction using serum samples from patients with inclusion body myositis (IBM). Tripartite motif containing 21 (TRIM21) was identified as a potentially new IBM autoantigen. We also expanded the application of PLATO-BC to identify protein interactions for JQ1, single ubiquitin peptide, and NS5 protein of Zika virus. From PLATO-BC analyses, we identified new protein interactions for these “bait” molecules. We demonstrate that Ewing sarcoma breakpoint region 1 (EWSR1) binds to JQ1 and their interactions may interrupt the EWSR1 association with acetylated histone H4. RIO kinase 3 (RIOK3), a newly identified ubiquitin-binding protein, is preferentially associated with K63-ubiquitin chain. We also find that Zika NS5 protein interacts with two previously unreported host proteins, par-3 family cell polarity regulator (PARD3) and chromosome 19 open reading frame 53 (C19orf53), whose attenuated expression benefits the replication of Zika virus. These results further demonstrate that PLATO-BC is capable of identifying novel protein interactions for various types of “bait” molecules.

2018-12-01·BMC Endocrine Disorders4区 · 医学

Hyperglycemia-related central pontine demyelinization after a binge-eating attack in a patient with type-2 diabetes: a case report

4区 · 医学

ArticleOA

作者: Noll, Arno ; Ibe, Richard ; Schreiber, Alexandra ; Girndt, Matthias ; Ackmann, Charlotte ; Katz, Alexandra ; Pliquett, Rainer U

BACKGROUNDHere, we report a case of central pontine demyelinization in a type-2 diabetes patient with hyperglycemia after a binge-eating attack in the absence of a relevant hyponatremia.CASE PRESENTATIONA 55-year-old, male type-2 diabetic patient with liver cirrhosis stage Child-Pugh B was admitted due to dysmetria of his right arm, gait disturbance, dizziness, vertigo, and polyuria, polydipsia after a binge-eating attack of sweets (a whole fruit cake and 2 Liters of soft drinks). A recently initiated insulin therapy had been discontinued for 8 months. A serum glucose measurement obtained 5 days prior to hospitalisation was 38.5 mmol/l (694 mg/dl). The patient graved for sweets since stopping alcohol consumption 8 months earlier. On admission, venous-blood glucose was 29.1 mmol/l (523.8 mg/dl), glycated hemoglobin was 168.0 mmol/mol or 17.6%. No supplementation of sodium chloride was reported. Laboratory exams revealed an elevated serum ammonia level (127.1 μmol/l), rendering a hepatic encephalopathy very likely. After initiation of insulin therapy, capillary glucose normalized, and serum sodium rose from 133 on admission to 144 mmol/l during the hospital stay. In retrospect, the mild hyponatremia on admission was classified as pseudohyponatremia due to hyperglycemia. The patient had an insulin resistance (HOMA-IR 7.8 (normal range < 2.5)). A T2-weighted magnetic resonance imaging (MRI) of the head and a cranial computed tomography scan were obtained demonstrating a symmetric central pontine demyelinization. After 26 days in hospital, the patient was discharged with an inkretin-mimetic therapy (dulaglutide SC, 1.5 mg/week) and an intensified conventional insulin therapy (insulin aspart: 14 units/d in euglycemia, insulin glargin 20 units/d).CONCLUSIONSCentral pontine and/or cerebellar myelinolysis can be caused by sudden, severe, and sustained hyperglycemia, especially when another risk factor (in this case, liver cirrhosis) is present. Functional neurological deficits in the context of hyperglycemia should prompt for the consideration of this differential diagnosis in all diabetes patients.

项与赖脯胰岛素/甘精胰岛素(Adocia SA) 相关的新闻（医药）

2024-07-10

·通化东宝

通化东宝2024半年度业绩预告：非经常性因素短期影响当期业绩下半年集采助力产品准入与放量

2024年7月10日，通化东宝药业股份有限公司（以下简称或“公司”）发布2024年半年度业绩预亏公告。上半年，公司预计实现营业收入约7.56亿元，同比减少44.66%；归属于上市公司股东的净利润-2.24亿元；归属于上市公司股东的扣除非经常性损益的净利润-801.47万元。公司业绩的下降主要系以下因素的影响：新一轮胰岛素集采落地带来公司产品价格下调的普遍预期，公司商业客户对库存进行控制与调整，对二季度公司发货造成一次性影响，因此销售收入同比下滑。经初步测算，上述因素将减少公司营业收入约 5.38亿元。由于胰岛素产品在运输和储存方面具有一定的特殊性，医院及配送商业公司均需要一定数量的安全库存。为了更好的落实胰岛素产品集采相关政策，公司对集采实施前存在于流通环节的全部库存产品，原供货价与集采实施价格之间的差额进行一次性冲销或返还。经初步测算，上述业务将减少公司营业收入约7,200万元，扣除所得税影响后，将减少公司净利润约6,120万元。为合理配置研发资源，聚焦研发管线中的优势项目，经审慎考量，公司决定终止可溶性甘精赖脯双胰岛素注射液研发项目（BC Combo）（THDB0207注射液）临床研究开发工作，公司对该项目研发资本化金额6,455.82万元全额计提资产减值准备，同时对2018年已经支付给Adocia公司与该项目相关的预付商业化权利款金额25,352.36万元确认为损失。上述两项会计处理将减少公司2024年半年度净利润2.70亿元，同时导致公司2024年半年度非经常性损益减少2.15亿元。以上业绩影响因素均为一次性或短期影响因素，下半年公司发货与销售工作将恢复正常，并且新一轮集采的施行将助力加快胰岛素产品准入与放量。报告期内，公司在集采接续、创新研发、对外合作等方面取得诸多成果。集采续标取得成功在4月的国家胰岛素集采续标中，公司全系列胰岛素产品成功以A类中选，其中，甘精胰岛素和预混型门冬胰岛素两大品种产品均以A1类中选，将大幅加快产品在全国范围内的准入与放量速度，并以更普惠的价格惠及更广大患者，助力医保降费，减轻患者经济负担，提升药品可及性和可负担性。随着下半年各省市第二轮胰岛素集采的实施，公司额外获得全国集采二次分配量中的30%以上，同时胰岛素类似物在医院准入方面实现巨大的提升和突破，包括甘精胰岛素新增准入约1,400家医院，门冬胰岛素新增准入约3,000家医院，预混型门冬胰岛素新增准入约5,000家医院。受益于本次集采带来的可观分配量和医院准入加速，公司未来将继续重点发力胰岛素类似物产品销售，继续稳步提升胰岛素全系列产品的销售量和市场份额，巩固公司作为中国糖尿病药物领域龙头企业的市场地位。创新研发全面推进 2024年以来，公司在研发上取得诸多进展。创新药方面，公司痛风一类新药URAT1抑制剂（THDBH130片）IIa期临床试验达到主要终点；具有First-in-class潜力的XO/URAT1双靶点抑制剂（THDBH151片）IIa期临床试验完成首例患者给药；GLP-1/GIP双靶点受体激动剂（注射用THDBH120）减重适应症申报临床获得批准，降糖适应症Ib期临床试验完成首例患者给药。此外，德谷胰岛素利拉鲁肽注射液I期临床试验完成首例患者给药。积极开展多项合作 2024年上半年，公司积极开展各项对外合作与投资，丰富产品体系，布局潜力赛道，加强渠道合作。与质肽生物达成合作，引进长效GLP-1产品司美格鲁肽注射液，加速构建起多层次、多样化的GLP-1产品梯队，打开广阔市场空间。公司获得了质肽生物司美格鲁肽糖尿病适应症在中国大陆地区的独占商业化权益，以及共同合作开发海外市场权利。战略入股君合盟，获得君合盟现有的及未来的研发项目在全球范围内的各类开发及商业合作优先权，前瞻布局消费医疗赛道，为公司未来发展蓄力积势。与国药控股达成战略合作，实现双方在分销渠道、物流配送、招标服务、市场准入等关键业务领域全面且深入合作。展望未来，公司将在新一轮集采的助力下大力发展胰岛素类似物销售，随着新准入全国更多医疗机构，以及集采分配量的逐步落实，公司将全力提升市场份额，为未来业绩增长贡献增量。与此同时，坚定不移加强创新研发和推进产品出海，研发更多高质量产品并加快推向更广阔的海外市场，实现公司长期价值的持续提升。关于通化东宝通化东宝药业股份有限公司（简称：“通化东宝”，股票代码：600867.SH）成立于1985年，1994年于上交所挂牌上市，是集药品研发、生产及销售为一体的国内著名药企。公司深耕糖尿病治疗领域，拥有以胰岛素为核心的产品体系，及为患者提供糖尿病治疗的整体化方案，公司现有产品主要包括人胰岛素原料药及注射剂、甘精胰岛素原料药及注射剂、门冬胰岛素及预混型门冬胰岛素注射液、GLP-1RA利拉鲁肽注射液、镇脑宁胶囊及糖尿病相关的医疗器械等。公司在建立了全面丰富的糖尿病治疗产品研发管线体系的基础上，不断扩大在研产品适应症覆盖范围，从糖尿病延伸至减肥、非酒精性脂肪肝炎（NASH）等适应症，并拓展包括痛风/高尿酸血症在内的其他内分泌代谢疾病治疗领域。未来，通化东宝将继续秉承“坚持自主创新，创造世界品牌”的发展理念，抢抓国家鼓励创新药、生物药的有利时机，以科技创新为驱动，不断提高生物制药的研发能力，加快技术成果转化步伐，为实现“内分泌领域创新医药研发的探索者和引领者”的企业愿景而不懈奋斗，为人类的健康事业作出新的、更大的贡献。了解通化东宝更多资讯可登录官网：www.thdb.com 往期文章一览通化东宝：拟回购8,000万元~12,000万元公司股份，用于股权激励及/或员工持股计划出海里程碑 | 通化东宝通过欧盟EMA上市批准前GMP检查通化东宝：GLP-1/GIP双靶点受体激动剂（注射用THDBH120）降糖适应症Ib期临床试验完成首例患者给药通化东宝：引进GLP-1产品司美格鲁肽注射液通化东宝：1亿元增资入股君合盟，前瞻布局潜力赛道通化东宝：痛风双靶点抑制剂（THDBH151片）IIa期临床试验完成首例患者给药通化东宝：全线胰岛素产品集采A类中选，2款大品种产品均以A1类中选！一图读懂 | 通化东宝2023年报通化东宝：痛风一类新药URAT1抑制剂（THDBH130片）IIa期临床试验达到主要终点通化东宝2023年度大事记——“创新研发+国际化” 通化东宝：一类新药口服小分子GLP-1受体激动剂（THDBH110胶囊）I期临床试验完成首例受试者入组通化东宝：与健友股份战略合作，进军美国胰岛素市场通化东宝：依托考昔片申报生产获得受理通化东宝：携手科兴制药，加速产品海外商业化

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100 项与赖脯胰岛素/甘精胰岛素(Adocia SA) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	临床2期	-	Adocia SA	-
1型糖尿病	药物发现	德国	Adocia SA	2016-03-14

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临床结果

适应症

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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


ADA2023	N/A	2型糖尿病	1,317	iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) (Insulin naïve)	(壓襯齋鏇壓鬱衊糧鬱鏇) = 鹹選繭窪艱製構廠壓憲衊鏇鹽願製顧簾遞鑰壓 (糧鹹夢獵繭繭膚範鹽築 ) 更多	-	2023-06-20
				Insulin treated	(壓襯齋鏇壓鬱衊糧鬱鏇) = 顧衊蓋積獵艱淵選衊網衊鏇鹽願製顧簾遞鑰壓 (糧鹹夢獵繭繭膚範鹽築 ) 更多
ADA2021	N/A	2型糖尿病	442	Fixed ratio combination of insulin glargine 100 U/ml and lixisenatide (iGlarLixi)	(鏇獵鏇襯糧窪簾夢壓範) = 遞襯糧鹽齋艱齋淵醖願窪獵壓蓋製蓋積遞廠糧 (艱窪膚願蓋餘顧廠鏇淵 ) 更多	积极	2021-06-01
NCT02915250 (EASD2018)	临床1期	2型糖尿病	-	BioChaperone Combo	壓獵鑰簾鏇膚願壓築遞(齋範簾醖淵鬱廠繭糧積) = numerically fewer subjects experiencing symptomatic hypoglycaemia compared to both Lispro Mix 25 and separate injections of glargine and lispro 積淵簾膚製繭艱衊願範 (廠構醖醖繭鹹夢襯築範 )	积极	2018-10-02
				Glargine and Lispro
NCT02514850 (not available, EASD2016)	临床1期	2型糖尿病	24	BioChaperone Combo	鬱範遞蓋鹽襯廠遞餘餘(糧簾憲獵獵築觸艱艱製) = 蓋遞遞艱顧襯製鹹範選構鏇鬱膚醖蓋鏇壓艱鑰 (積夢範鏇製糧繭選範餘, 227) 更多	积极	2016-09-13
				Lispro	鬱範遞蓋鹽襯廠遞餘餘(糧簾憲獵獵築觸艱艱製) = 繭遞鏇鹹鹽齋製蓋艱簾構鏇鬱膚醖蓋鏇壓艱鑰 (積夢範鏇製糧繭選範餘, 184) 更多
NCT02514954 (EASD2016)	临床1期	1型糖尿病	-	BC Combo	鹽鹹憲餘範衊鏇遞觸鹹(鏇齋簾選鹹獵鹽襯鑰襯) = 鏇鏇構鹽簾襯艱齋夢憲顧繭憲簾夢齋鏇簾鬱遞 (鏇選廠膚願築顧淵襯夢, (-31 ~ 166)) 更多	积极	2016-09-13
				Lispro Mix 75/25 (LMx)	鹽鹹憲餘範衊鏇遞觸鹹(鏇齋簾選鹹獵鹽襯鑰襯) = 鏇簾壓獵淵齋鹹蓋範鹽顧繭憲簾夢齋鏇簾鬱遞 (鏇選廠膚願築顧淵襯夢, (20 ~ 194))
EDICT (Pubmed \| Diabetes Obes Metab)	N/A	糖尿病追加	-	Metformin/pioglitazone/exenatide	(鏇遞遞遞願顧獵憲膚壓) = 夢獵鏇觸醖簾淵構衊衊積簾遞繭糧鏇積衊廠鬱 (獵淵鹹鬱糧網獵鬱膚齋 )	积极	2015-03-01
				Metformin/sulfonylurea/glargine insulin	(鏇遞遞遞願顧獵憲膚壓) = 齋願繭壓繭淵鑰鏇積遞積簾遞繭糧鏇積衊廠鬱 (獵淵鹹鬱糧網獵鬱膚齋 ) 更多