This is a phase II, proof-of-concept, placebo-controlled, double-blind, cross-over randomized clinical trial, assessing the effect of canagliflozin on peritoneal membrane function in patients on PD.
The primary aim of this trial is to determine the short-term effects of canagliflozin, an SGLT-2 inhibitor, on glucose absorption by the peritoneal membrane and on ultrafiltration, as assessed by a standardized peritoneal equilibrium test. The secondary aims are to determine the effect of canagliflozin on solute clearance and on effluent biomarkers of inflammation, angiogenesis, and fibrosis at 26 weeks. We hypothesize that canagliflozin will prevent glucose absorption by the peritoneal membrane, as compared with placebo, and will attenuate the development of inflammation, angiogenesis, and fibrosis of the peritoneal membrane, as assessed by relevant biomarkers in the dialysate.

开始日期2025-09-01

申办/合作机构

Canadian Institutes of Health Research

NCT07076823

/ Recruiting临床1期IIT

Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer: a Phase I Trial

Colorectal cancer (CRC), ranking third in incidence among men and second in women globally with third-highest mortality in the US, remains a major health challenge despite multimodal therapies, particularly for advanced-stage patients with poor prognosis where immune checkpoint inhibitors (ICIs) like PD-1/PD-L1 blockers have emerged as transformative agents by reinvigorating anti-tumor immunity through PD-1/PD-L1 pathway inhibition. While MSI-H CRC's high mutational burden renders it susceptible to immunotherapy, clinical trials demonstrate durable responses with domestic ICIs such as tislelizumab showing 41.2% ORR, 14.4-month PFS, and 28.7-month OS in metastatic MSI-H CRC, yet unmet needs persist. Intriguingly, SGLT-2 inhibitor exhibit promising oncolytic potential, particularly when combined with ICIs, as evidenced by observational studies revealing enhanced tumor control in pancreatic ductal adenocarcinoma through metabolic-immunologic crosstalk and our preclinical data showing synergistic CRC growth suppression with the SGLT-2 inhibitor canagliflozin plus PD-1 blockade. This phase II trial investigates the safety and efficacy of canagliflozin-tislelizumab combination in metastatic MSI-H CRC, evaluating its impact on PFS, OS, and ORR while dissecting tumor microenvironment modulation mechanisms, thereby pioneering a novel metabolic-immunotherapy paradigm that could redefine treatment paradigms through dual metabolic-immune regulation.

开始日期2025-07-31

申办/合作机构

四川大学华西医院（四川省国际医院）

CTIS2024-519109-36-00

/ Recruiting临床1期

- BLCL-CAN-EU-01

开始日期2025-07-09

申办/合作机构

Tecnimede Sociedade Tecnico Medicinal SA

100 项与卡格列净相关的临床结果

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100 项与卡格列净相关的转化医学

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100 项与卡格列净相关的专利（医药）

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2,285

项与卡格列净相关的文献（医药）

2025-12-01·Current Neurology and Neuroscience Reports

The Role of Diabetes and SGLT2 Inhibitors in Cerebrovascular Diseases

Review

作者: Moustafa, Bayan ; Trifan, Gabriela

PURPOSE OF REVIEW:

Diabetes is a well-established risk factor for stroke. Understanding the pathophysiology of this connection is crucial to implementing appropriate prevention strategies. Lately, there has been a paradigm shift in the care of individuals with diabetes toward the use of glucose-lowering medications with potential cardiovascular, cerebrovascular or cardiorenal benefits. The aim of this article is to provide a critical analysis of the role of diabetes in cerebrovascular disease and current evidence and recommendations for the use of glucose-lowering medication with particular focus on the sodium glucose cotransporter-2 inhibitor (SGLT2i) class.

RECENT FINDINGS:

Intensive glycemic control in individuals with diabetes reduces the risk of microvascular complications, but there is less clear evidence for decreasing risk of macrovascular events (e.g., stroke). A multifaceted management of diabetes addressing healthy lifestyle practices, glycemic control, and optimization of other cardiovascular risk factors is highly recommended. SGLT2i are the latest class of antihyperglycemic agents available for diabetes management. Canagliflozin and empagliflozin are associated with reduction in major adverse cardiovascular events (MACE). Dapagliflozin did not reduce the rate of MACE but is associated with reduction in heart-failure related death and hospitalization and has the potential to decrease dementia risk. Ertugliflozin decreases rates of hospitalization related to heart failure however it was non-inferior to placebo in reducing MACE. There is increasing evidence that the use of SGLT2i may reduce the risk of stroke, particularly hemorrhagic stroke, in individuals with type 2 diabetes and a high risk of cardiovascular events, and that SGLT2i may also be beneficial for brain health by decreasing risk of cognitive decline and dementia. Antihyperglycemic therapy should be tailored to patients' circumstances. SGLT2i treatment should be considered in patients with type 2 diabetes and established or high-risk cardiovascular disease, heart failure, or chronic kidney disease, to reduce the overall cerebro-cardiovascular and renal risks.

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Potential anticancer effects of sodium-glucose cotransporter protein 2 (SGLT2) inhibitors Canagliflozin and Dapagliflozin

Review

作者: Dong, Weiyu ; Wang, Yanyan ; Fan, Shaohua

The use of sodium-glucose cotransporter protein 2 (SGLT2) inhibitors, specifically canagliflozin and dapagliflozin, has expanded from diabetes treatment to promising anticancer applications. Epidemiological links between diabetes and certain cancers highlight the potential of these agents in oncology, as SGLT2 is highly expressed in various tumor types. By inhibiting glucose uptake, canagliflozin and dapagliflozin disrupt glycolysis-dependent tumor growth, promoting apoptosis and reducing proliferation across multiple cancer models, including liver, prostate, and lung cancers. Key pathways involved in these effects include PI3K/AKT, mTOR, and AMPK signaling. Importantly, the combination of SGLT2 inhibitors with chemotherapy or radiotherapy has been shown to enhance antitumor efficacy and reduce treatment resistance, underscoring their potential as adjunctive therapies. However, adverse effects, such as increased risk of infection, and the need for more comprehensive mechanistic studies limit current applications. Future research should focus on expanding the understanding of these mechanisms, evaluating efficacy in additional tumor types, and optimizing combination therapies to mitigate side effects. SGLT2 inhibitors thus represent a novel class of metabolic modulators with potential for significant impact in cancer therapeutics.

2025-12-01·American journal of medicine open

The Association of SGLT2i vs DPP4i on Fracture: A Cohort Study in Veterans with Diabetes

Article

作者: Hackstadt, Amber ; Griffin, Katherine ; Javid, Amir ; Hung, Adriana ; Snyder, Kathryn ; Roumie, Christianne L ; Greevy, Robert

Background:

Increased bone turnover is associated with use of SGLT2i. Patients with diabetes experience adverse effects on bone metabolism. Our aim was to evaluate if SGLT2i was associated with fractures vs DPP4i as add-on therapy to diabetes regimens.

Methods:

We assembled a retrospective cohort of Veterans with diabetes combining Veterans Administration, Medicare, and National Death Index databases. Using an active comparator new user design, patients starting on SGLT2i or DPP4i were followed from prescription fill until a fracture event, death, stopping medication, loss of follow-up, or study end. Fractures included: face/skull, spine, ribs, long bones, hand/feet/digits, or hip. Fractures were identified based on a validated algorithm with positive predictive value 91.3% (86.8, 94.4). Cox models compared the association of fractures between SGLT2i and DPP4i in a propensity score-weighted cohort that balanced 70+ covariates including comorbidities, vital signs, labs, vitamin D levels, smoking, and medications.

Results:

The unweighted sample included 115,124 SGLT2i episodes (104,086 Veterans; 94% empagliflozin; 4% canagliflozin; 2% dapagliflozin) and 213,095 DPP4i episodes (173,724 Veterans; 45% saxagliptin; 15% sitagliptin; 34% alogliptin; 6% Linagliptin). After propensity score calculation and matched weighting, the cohort included 76,072 SGLT2i and 75,833 DPP4i episodes. Median age was 69.3 years and diabetes duration 9.7 (6.1, 14.0) years. In the matched weighted analyses, there were 1431 and 1564 fractures among SGLT2i and DPP4i users, respectively. There were no clinical differences in fractures per 1000 person-years: 18.2 (17.4, 19.1) vs 19.8 (19.0, 20.6). The adjusted hazard ratio (adjusted hazard ratio 0.93 [0.87, 0.99]) excluded increased risk of fractures (adjusted hazard ratio > 1) in SGLT2i users.

Conclusions:

SGLT2i use as add-on treatment for diabetes was not associated with increased fracture outcomes compared to DPP4i.

181

项与卡格列净相关的新闻（医药）

2025-08-01

·国家药品监督管理局

国家药监局公布药品说明书适老化及无障碍改革试点名单（第五批）

根据《国家药监局关于发布药品说明书适老化及无障碍改革试点工作方案的公告》（2023年第142号），省级药品监管部门和国家药监局药品审评中心报送了参与试点的药品上市许可持有人和药品名单（第五批），现予公布。序号药品名称上市许可持有人1维格列汀片华润赛科药业有限责任公司2氨氯地平阿托伐他汀钙片华润赛科药业有限责任公司3奥美沙坦酯氢氯噻嗪片华润赛科药业有限责任公司4缬沙坦氨氯地平片（I）华润赛科药业有限责任公司5米拉贝隆缓释片华润赛科药业有限责任公司6非那雄胺片华润赛科药业有限责任公司7奥美沙坦酯氨氯地平片华润赛科药业有限责任公司8格列齐特缓释片津药达仁堂集团股份有限公司新新制药厂9硫酸氨基葡萄糖胶囊天津天士力圣特制药有限公司10培哚普利吲达帕胺片施维雅（天津）制药有限公司11妇科回生丸北京同仁堂天然药物（唐山）有限公司12七宝美髯丸北京同仁堂天然药物（唐山）有限公司13金牛眼药河北金牛药业科技有限公司14特灵眼药河北金牛药业科技有限公司15复方甲硝唑阴道栓河北金牛药业科技有限公司16牛黄解毒片山西华康药业股份有限公司17三黄片山西华康药业股份有限公司18盐酸氟西汀胶囊山西仟源医药集团股份有限公司19盐酸舍曲林片山西仟源医药集团股份有限公司20磷霉素氨丁三醇散山西仟源医药集团股份有限公司21双歧杆菌乳杆菌三联活菌片内蒙古双奇药业股份有限公司22阴道用乳杆菌活菌胶囊内蒙古双奇药业股份有限公司23麝香通心滴丸内蒙古康恩贝药业有限公司24养血安神片内蒙古大唐药业股份有限公司25康复春口服液内蒙古大唐药业股份有限公司26天麻丸内蒙古大唐药业股份有限公司27六味地黄丸内蒙古大唐药业股份有限公司28参竹精胶囊内蒙古京新药业有限公司29六味地黄丸内蒙古京新药业有限公司30明目地黄丸内蒙古天奇中蒙制药股份有限公司31知柏地黄丸内蒙古天奇中蒙制药股份有限公司32六味地黄丸内蒙古天奇中蒙制药股份有限公司33柏子养心丸内蒙古天奇中蒙制药股份有限公司34养阴清肺丸内蒙古天奇中蒙制药股份有限公司35艾地骨化醇软胶囊大连美创药业有限公司36西尼地平软胶囊大连美创药业有限公司37阿奇霉素片辉瑞制药科技有限公司38阿奇霉素干混悬剂辉瑞制药科技有限公司39阿托伐他汀钙片晖致制药（大连）有限公司40苯磺酸氨氯地平片晖致制药（大连）有限公司41外用红色诺卡氏菌细胞壁骨架辽宁天安生物制药股份有限公司42左氧氟沙星片长春海悦药业股份有限公司43他达拉非片长春海悦药业股份有限公司44苯磺酸氨氯地平片长春海悦药业股份有限公司45非诺贝酸片长春海悦药业股份有限公司46缬沙坦氨氯地平片（I）长春海悦药业股份有限公司47伏立康唑片长春海悦药业股份有限公司48拉米夫定片长春海悦药业股份有限公司49孟鲁司特钠颗粒长春海悦药业股份有限公司50艾司奥美拉唑镁碳酸氢钠胶囊长春海悦药业股份有限公司51阿奇霉素干混悬剂长春海悦药业股份有限公司52厄贝沙坦片修正药业集团股份有限公司53通窍鼻炎片修正药业集团股份有限公司54感冒清热颗粒修正药业集团股份有限公司55复方氨酚烷胺片修正药业集团股份有限公司56清肺抑火片修正药业集团股份有限公司57缬沙坦氨氯地平片（I）江苏万高药业股份有限公司58瑞舒伐他汀钙片江苏万高药业股份有限公司59厄贝沙坦氢氯噻嗪分散片江苏万高药业股份有限公司60厄贝沙坦氢氯噻嗪片江苏万高药业股份有限公司61盐酸奥洛他定颗粒江苏万高药业股份有限公司62缬沙坦氢氯噻嗪片江苏万高药业股份有限公司63阿司匹林肠溶片江苏万高药业股份有限公司64磷酸奥司他韦干混悬剂江苏万高药业股份有限公司65盐酸二甲双胍格列吡嗪片德全药品(江苏)股份有限公司66酮咯酸氨丁三醇片德全药品(江苏)股份有限公司67黄葵胶囊苏中药业集团股份有限公司68达格列净片阿斯利康药业（中国）有限公司69二甲双胍格列吡嗪胶囊卓和药业集团股份有限公司70依折麦布片常州制药厂有限公司71左乙拉西坦缓释片常州制药厂有限公司72他达拉非片常州制药厂有限公司73利伐沙班片常州制药厂有限公司74替格瑞洛片常州制药厂有限公司75塞来昔布胶囊常州制药厂有限公司76左甲状腺素钠片默克制药（江苏）有限公司77富马酸比索洛尔片默克制药（江苏）有限公司78盐酸二甲双胍片默克制药（江苏）有限公司79盐酸二甲双胍缓释片默克制药（江苏）有限公司80盐酸丁螺环酮片江苏恩华药业股份有限公司81硫酸艾玛昔替尼片江苏恒瑞医药股份有限公司82马来酸吡咯替尼片江苏恒瑞医药股份有限公司83甲磺酸阿美替尼片江苏豪森药业集团有限公司84聚乙二醇洛塞那肽注射液江苏豪森药业集团有限公司85达比加群酯胶囊南京正大天晴制药有限公司86奥美沙坦酯氨氯地平片南京正大天晴制药有限公司87硫酸氢氯吡格雷片南京正大天晴制药有限公司88厄贝沙坦氢氯噻嗪片南京正大天晴制药有限公司89依达拉奉右莰醇舌下片先声药业有限公司90乙酰半胱氨酸泡腾片江苏安必生制药有限公司91艾司奥美拉唑镁肠溶胶囊江苏中邦制药有限公司92氟比洛芬凝胶贴膏乐明药业(苏州)有限公司93洛索洛芬钠凝胶贴膏乐明药业(苏州)有限公司94盐酸莫西沙星片扬子江药业集团江苏紫龙药业有限公司95泊沙康唑肠溶片江苏海岸药业有限公司96左氧氟沙星片江苏悦兴医药技术有限公司97富马酸替诺福韦二吡呋酯片苏州弘森药业股份有限公司98盐酸度洛西汀肠溶胶囊宁波美诺华天康药业有限公司99阿卡波糖咀嚼片杭州中美华东制药有限公司100百令片杭州中美华东制药有限公司101奥利司他胶囊杭州中美华东制药有限公司102固本咳喘颗粒杭州中美华东制药有限公司103奥美拉唑碳酸氢钠胶囊杭州中美华东制药有限公司104环孢素口服溶液杭州中美华东制药有限公司105西罗莫司口服溶液杭州中美华东制药有限公司106他克莫司缓释胶囊杭州中美华东制药有限公司107他克莫司软膏杭州中美华东制药有限公司108吗替麦考酚酯干混悬剂杭州中美华东制药有限公司109西格列汀二甲双胍片（I）杭州中美华东制药有限公司110西格列汀二甲双胍片（II）杭州中美华东制药有限公司111卡格列净片杭州中美华东制药有限公司112马昔腾坦片杭州中美华东制药有限公司113吲哚布芬片杭州中美华东制药有限公司114替格瑞洛片浙江诺得药业有限公司115盐酸米诺环素胶囊瀚晖制药有限公司116厄贝沙坦片瀚晖制药有限公司117氟伐他汀钠胶囊瀚晖制药有限公司118普伐他汀钠片瀚晖制药有限公司119甲泼尼龙片瀚晖制药有限公司120枸橼酸托法替布片宏越科技（湖州）有限公司121左氧氟沙星片浙江普洛康裕制药有限公司122琥珀酸美托洛尔缓释片浙江普洛康裕制药有限公司123枸橼酸托法替布片浙江施强制药有限公司124盐酸文拉法辛缓释胶囊杭州康恩贝制药有限公司125佐米曲普坦片杭州康恩贝制药有限公司126铝碳酸镁咀嚼片杭州康恩贝制药有限公司127萘普生肠溶微丸胶囊杭州康恩贝制药有限公司128蒙脱石散杭州康恩贝制药有限公司129格列齐特片（II）浙江京新药业股份有限公司130替米沙坦片浙江京新药业股份有限公司131托拉塞米片浙江华海药业股份有限公司132氯沙坦钾氢氯噻嗪片浙江华海药业股份有限公司133二甲双胍恩格列净片（I）浙江华海药业股份有限公司134二甲双胍恩格列净片（VI）浙江华海药业股份有限公司135利格列汀二甲双胍片（II）浙江华海药业股份有限公司136他克莫司软膏福元药业有限公司137磷酸奥司他韦胶囊山东新时代药业有限公司138阿瑞匹坦胶囊山东新时代药业有限公司139盐酸伊伐布雷定片山东新时代药业有限公司140磷酸西格列汀片山东新时代药业有限公司141他达拉非片山东新时代药业有限公司142阿立哌唑片山东京卫制药有限公司143盐酸文拉法辛缓释胶囊山东京卫制药有限公司144盐酸舍曲林片山东京卫制药有限公司145阿戈美拉汀片山东京卫制药有限公司146马来酸氟伏沙明片山东京卫制药有限公司147盐酸鲁拉西酮片山东京卫制药有限公司148富马酸喹硫平缓释片山东京卫制药有限公司149健脑补肾丸荣昌制药（淄博）有限公司150甜梦胶囊荣昌制药（淄博）有限公司151雷贝拉唑钠肠溶片山东新华制药股份有限公司152阿托伐他汀钙片山东新华制药股份有限公司153布洛芬缓释胶囊山东新华制药股份有限公司154缬沙坦氨氯地平片山东新华制药股份有限公司155苯磺酸左氨氯地平片山东新华制药股份有限公司156厄贝沙坦片山东新华制药股份有限公司157厄贝沙坦氢氯噻嗪片山东新华制药股份有限公司158苯磺酸氨氯地平片山东新华制药股份有限公司159降脂宁颗粒湖南状元制药有限公司160通脉颗粒湖南状元制药有限公司161风寒感冒颗粒江右制药（常德）有限公司162健胃消食片江右制药（常德）有限公司163木香顺气丸江右制药（常德）有限公司164开胸顺气丸江右制药（常德）有限公司165三七片江右制药（常德）有限公司166乳果糖口服溶液江右制药（常德）有限公司167铝碳酸镁咀嚼片江右制药（常德）有限公司168麻仁胶囊江右制药（常德）有限公司169西青果颗粒江右制药（常德）有限公司170补肾养血丸江右制药（常德）有限公司171茶碱缓释片湖南绅泰春制药股份有限公司172磷酸奥司他韦胶囊海南亚洲制药股份有限公司173庆大霉素普鲁卡因维B12颗粒海南亚洲制药服份有限公司174多潘立酮片海南亚洲制药服份有限公司175银杏叶片海南亚洲制药服份有限公司176硫酸羟氯喹片重庆博腾药业有限公司177洛索洛芬钠口服溶液重庆华邦制药有限公司178盐酸氨溴索口崩片重庆康刻尔制药股份有限公司179氯雷他定口腔崩解片重庆康刻尔制药股份有限公司180铝碳酸镁颗粒（双跨）重庆康刻尔制药股份有限公司181黄藤素胶囊重庆康刻尔制药股份有限公司182格列齐特胶囊重庆康刻尔制药股份有限公司183二甲双胍恩格列净片（I）重庆希韦医药科技有限公司184二甲双胍恩格列净片（VI）重庆希韦医药科技有限公司185左氧氟沙星片重庆药谷制药有限公司186盐酸羟考酮缓释片西南药业股份有限公司187异烟肼片西南药业股份有限公司188氢溴酸西酞普兰片西南药业股份有限公司189烟酸缓释片西南药业股份有限公司190辛伐他汀片西南药业股份有限公司191阿莫西林分散片西南药业股份有限公司192青霉素VK片西南药业股份有限公司193阿莫西林胶囊西南药业股份有限公司194地高辛片西南药业股份有限公司195盐酸异丙嗪片西南药业股份有限公司196喷托维林氯化铵片西南药业股份有限公司197甲磺酸雷沙吉兰片重庆华森制药股份有限公司198鹿仙补肾片云南康恩贝希陶药业有限公司199感冒疏风颗粒云南康恩贝希陶药业有限公司200肠舒片云南康恩贝希陶药业有限公司201龙金通淋胶囊云南康恩贝希陶药业有限公司202三七药酒云南康恩贝希陶药业有限公司203感冒清热颗粒云南康恩贝希陶药业有限公司204小儿止咳糖浆云南康恩贝希陶药业有限公司205消炎止咳片云南康恩贝希陶药业有限公司206降脂宁颗粒云南康恩贝希陶药业有限公司207金砂五淋丸云南康恩贝希陶药业有限公司208红药胶囊云南康恩贝希陶药业有限公司209红草止鼾胶囊云南康恩贝希陶药业有限公司210萆薢分清丸云南康恩贝希陶药业有限公司211妇炎舒片云南康恩贝希陶药业有限公司212益肾健骨片云南康恩贝希陶药业有限公司213血塞通分散片云南植物药业有限公司214七叶神安片云南植物药业有限公司215三七龙血竭胶囊云南圣科药业有限公司216骨痛灵酊云南圣科药业有限公司217培哚普利氨氯地平片（III）LESLABORATOIRESSERVIER218盐酸贝尼地平片KyowaKirinCo.,Ltd219达格列净二甲双胍缓释片（I）AstraZenecaAB220达格列净二甲双胍缓释片（II）AstraZenecaAB221达格列净二甲双胍缓释片（III）AstraZenecaAB222达格列净二甲双胍缓释片（IV）AstraZenecaAB

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2025-07-30

·国际糖尿病idiabetes

温俊平教授：不只是降糖，糖尿病治疗正在进入“多靶点协同”新时代！ | 西湖论糖

点击“蓝字”关注我们编者按：在第四届“西湖论糖”会议上，福州大学附属省立医院温俊平教授围绕“心血管-肾脏-代谢综合管控：如何实现Treat to Success”进行了精彩报告，从患病现状、临床证据、治疗理念转变再到药物策略重构，系统阐述了糖尿病合并多系统慢病的整体管理逻辑。温教授指出，随着大量心血管结局研究（CVOT）的推进和指南持续更新，糖尿病的治疗目标已从“降糖达标”转向“风险干预优先”，强调早期识别、联合干预和心肾器官保护，才能真正实现“治疗成功”的最终目标。一、中国糖尿病防控形势严峻，早期强化控糖已成共识中国糖尿病防控形势依旧严峻，患病率持续攀升，控制率仍不理想。2022年中国疾病预防控制中心发布“中国糖尿病地图”，根据拟合曲线估算，过去40年间我国2型糖尿病（T2DM）患病率呈持续增长态势，其中2015～2019年中国T2DM患病率为14.92％。然而，糖尿病的控制情况仍不尽如人意。一项纳入超过17万人群的全国性数据显示[1]，尽管知晓率和治疗率略有提升，但真正实现血糖达标的患者比例依旧偏低。2018年，T2DM患者中36.7%知晓自身患病，32.9%接受治疗，而在接受治疗者中，血糖控制达标者仅占50.1%；与2013年相比，这些指标无显著改善[1]。面对上述防控困境，如何通过科学管理改善预后？近年来循证研究逐渐指向“早期干预”的核心价值——在控制血糖目标方面，越来越多循证研究提出，“起步即强化”或“尽早达标”应成为T2DM管理新范式。UKPDS研究证实，T2DM患者早期控糖，可实现长远心肾获益。该研究纳入5102例新诊断T2DM患者，结果显示[2]，强化治疗组在微血管并发症发生率方面显著优于常规组。其10年后延伸随访进一步发现，新诊断T2DM患者早期强化血糖达标可降低微血管疾病风险24%、心肌梗死风险15%。这说明即使强化治疗终止，早期控糖所带来的大血管保护效益仍然持续存在，即所谓“代谢记忆”效应。与之相对，VADT研究在平均病程11.5年的T2DM患者中实施强化降糖治疗[3]，结果发现其对主要心血管终点事件的改善有限——提示在疾病较晚阶段介入，可能难以逆转早期高血糖造成的器官损伤。因此，确诊早期即进行强化干预，对长期预后改善具有决定性意义。二、T2DM患者心肾风险高度共存，需及早识别与干预在中国，糖尿病患者的心肾风险普遍存在，需引起高度关注。一项覆盖9672例T2DM患者的研究显示，约31%的患者合并慢性肾脏病（CKD），其中27.4%伴有尿白蛋白/肌酐比值（UACR，反映肾脏损伤的早期指标）升高[4]。与此同时，另一项纳入25 817例T2DM患者的大型多中心研究发现，约72%的患者存在高心血管风险[5]。研究还表明，随着UACR水平升高，T2DM患者发生心血管事件的风险升高约2.5倍，发生终末期肾病（ESRD）的风险升高约3.0倍[6~7]。此外，若心血管与肾脏风险因素共存，患者发生心血管事件的风险进一步增加3~6倍[8]，提示早期识别与联合干预心肾共病状态对糖尿病管理具有重要意义。这种普遍存在的心肾风险并非孤立存在——心肾风险贯穿糖尿病始终，会加速疾病进程，诱发不良结局[9]。心肾代谢风险在T2DM确诊之初即已存在，随着疾病进展，心力衰竭（HF）和CKD等疾病的发生风险逐步升高，并可诱发动脉粥样硬化、血栓形成等严重事件。若未及时干预，患者将面临心肾功能恶化、反复住院，最终发展至死亡的不良结局。三、糖尿病管理策略逐渐升级为Treat to Success近年来，随着多项CVOT研究陆续完成，钠-葡萄糖共转运蛋白2抑制剂（SGLT2i）与胰高糖素样肽-1受体激动剂（GLP-1RA）类药物在心肾保护方面的疗效逐渐显现[10]。其中，SGLT2i（如恩格列净、达格列净、卡格列净）及部分GLP-1RA（如司美格鲁肽、利拉鲁肽）已在多个CVOT中证实可降低MACE（主要不良心血管事件，包括心肌梗死、卒中等）、HF住院率、肾功能恶化等硬终点事件，显著改变了糖尿病治疗的重心。SGLT2i在心肾保护领域的多项研究证据持续涌现：卡格列净在CREDENCE试验中首次证实具备肾脏保护作用，达格列净和恩格列净则在DAPA-CKD、EMPA-Kidney等研究中进一步巩固了对CKD进展的延缓效果；同时，DAPA-HF、EMPEROR-R、DELIVER等试验显示其可显著降低HF住院和心血管死亡风险。这些证据共同体现了SGLT2i“心肾双保护”的核心特征，并促使糖尿病管理从单纯降糖治疗向心肾疾病全程保护转变[11]。随着证据积累，T2DM管理理念正从“以降糖为中心”转向“以心肾结局为导向”的综合策略。2025年版ADA指南明确提出如下建议[12]：对合并动脉粥样硬化性心血管疾病（ASCVD）或确诊高危风险因素的T2DM成人患者，治疗计划应包括已证实可减少心血管事件的药物（如SGLT2i和/或GLP-1RA），用于血糖管理和全面的心血管风险降低（与HbA1c无关）（A类推荐）；对已确诊HF（无论射血分数降低或保留）的T2DM成人患者，均推荐使用SGLT2i，用于血糖管理和预防HF住院（与HbA1c无关）（A类推荐）；对确诊CKD（eGFR 20~60 ml/min/1.73 m2和/或白蛋白尿）的T2DM患者，应使用已证实有益的SGLT2i或GLP-1RA，用于血糖管理（与HbA1c无关）及减缓CKD的进展、减少心血管事件（A类推荐）。《2023国家代谢性疾病管理中心（MMC）指南》[13]亦提出“糖-心-肾共管”理念：倡导从初诊起即同步管理血糖、心血管及肾脏风险；并指出对于HbA1c≥7.5%的患者，若生活方式干预无效，应直接起始联合治疗。早期联合治疗可增加降糖持久性，同时兼顾体重控制和心肾保护等临床效益。此外，固定剂量复方制剂（FDC）能简化治疗方案，相比自由联合方案，HbA1c降幅更显著，患者依从性也更高。综上，糖尿病治疗已从“单纯血糖控制”全面升级为以“心肾结局”为中心的综合管理策略。而“Treat to Success”的糖尿病管理策略，正是这一理念的具体实践——强调在“早期血糖达标（Treat to Target）”与“获得心肾结局改善（Treat to Benefit）”之间实现平衡。四、结语中国糖尿病防控形势依旧严峻，患病率持续攀升，控制率仍有待提高。在此背景下，早期强化干预和以心肾结局为导向的治疗理念正逐步成为T2DM管理共识。从“早期强化”到“Treat to Success”，临床证据不断强调：只有在T2DM确诊初期即同步控制血糖、心血管及肾脏风险（实现“糖-心-肾”协同管理），才能真正延缓并发症进展、改善患者远期预后。而SGLT2i和GLP-1RA类药物在心肾获益方面的研究证据不断积累，为这一目标提供了切实可行的治疗工具——T2DM治疗由此正迈向以“血糖达标+心肾保护”为双核心目标的综合管理新时代。未来，如何在实际临床中更早识别高危患者、制定个体化共病共管策略，将成为提升糖尿病管理质量、最终改善患者生存结局的关键所在。专家简介温俊平教授福州大学附属省立医院医学博士，教授，博士生导师，主任医师福州大学附属省立医院（福建省立医院）内分泌科主任中国医师协会内分泌代谢科医师分会委员福建省医学会内分泌学分会常委福建省医师协会内分泌代谢科医师分会副会长福建省中西医结合学会糖尿病分会副主任委员福建省海医会内分泌代谢病学分会副会长《中华内分泌代谢杂志》通讯编委《ADA精粹中文版》编委参考文献（上下滑动可查看）1.Limin W, et al. JAMA. 2021 Dec 28;326(24):2498-25062.Holman RR, et al. N Engl J Med. 2008 Oct 9;359(15):1577-15893.VADT Investigators.N Engl J Med. 2009 Jan 8; 360(2)129-1334.2023 ADA meeting,1373-P:The Prevalence and Risk Factors of Chronic Kidney Disease in Patients with Type 2 Diabetes in China5.Ji L, et al. Am J Med. 2013 Oct; 126(10):925.e11-22.6.Ninomiya T. et al. J Am Soc Nephrol.2009 Aug;20(8):1813-1821.7.Carrero JJ, et al. Kidney Int.2017 Jan;91(1)244-251.8.Lu S,et al. Ann Transl Med. 2019 Sep;7(18):4369.Diabetes Obes Metab. 2020;22:1481-149510.中华糖尿病杂志, 2022,14(5): 416-42211.European Journal of Preventive Cardiology, 2021;, zwab03412.Diabetes Care. 2024 Jan 1;47(Suppl 1):S158-S17813.2023国家标准化代谢性疾病管理中心（MMC）代谢病管理指南第二版声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

临床结果临床研究临床终止

2025-07-25

·EndPoints

CHMP backs Lilly’s Alzheimer’s drug in certain patients, Gilead’s twice-yearly HIV prevention shot, among others

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) landed on a number of high-profile decisions this week, including changing course on Eli Lilly’s Alzheimer’s drug in certain patients and recommending Gilead’s twice-yearly HIV preventive approach. Overall, CHMP said Friday that it is endorsing the authorization of 13 new medicines. It also said that the European Commission should reject three drugs, including Sarepta’s troubled Duchenne drug Elevidys , which Roche is licensed to distribute in Europe. Lilly’s Alzheimer’s drug Kisunla initially received a negative opinion in March. At the time, CHMP noted the benefits of the drug did not outweigh the risks of patients developing bleedings and swellings of the brain called amyloid-related imaging abnormalities (ARIA), which can be fatal. Kisunla was approved in the US in July 2024. CHMP has now reversed its previously negative opinion on Kisunla after reviewing Lilly’s new dosing plan, which includes starting off with a lower dose and additional measures to reduce the risk of ARIAs. Regulators have been wary of approving drugs with risks of ARIAs, such as Eisai and Biogen’s Alzheimer’s drug Leqembi, which was also initially rejected by the EMA last July. Since then, Leqembi was approved by the EC in April this year, becoming the first of its kind to be approved in Europe. It secured FDA approval in January. CHMP also endorsed Gilead’s twice-yearly injectable lenacapavir to prevent HIV. Lenacapavir is currently approved in Europe as a treatment for adults with multidrug-resistant HIV-1 infection, and not as a preventive measure. In a landmark move, lenacapavir was approved as PrEP in the US last month under the brand name Yeztugo. The same preventive product would have a different name in the EU : Yeytuo. Elsewhere, the European regulators also gave a positive opinion for Pfizer and BioNTech’s LP.8.1-adapted monovalent Covid-19 vaccine for individuals aged six months and older. This comes after the EMA’s Emergency Task Force recommended in May that Covid-19 vaccines need to be updated to target the LP.8.1 strain. Pfizer and BioNTech have already started manufacturing their LP.8.1-adapted Covid-19 vaccine. As soon as the EC gives its approval, the companies will be ready to ship the vaccine, they said in a Friday release . CHMP also recommended the approval of the following products: The EU regulators suggested recommending the following label expansions: CHMP recommended rejecting TETEC Tissue Engineering Technologies’ autologous cartilage-derived articular chondrocytes called Jelrix, as well as Prilenia Therapeutics’ Huntington’s disease drug Nurzigma.

上市批准疫苗

100 项与卡格列净相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09592	卡格列净	A10BK02	DB08907

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
2型糖尿病肾脏病	日本	Mitsubishi Tanabe Pharma Corp.	2022-06-20
糖尿病肾病	美国	Janssen Pharmaceuticals, Inc.	2019-09-27
2型糖尿病	美国	Janssen Pharmaceuticals, Inc.	2013-03-29

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
心脏衰竭	临床3期	美国	Janssen Research & Development LLC	2020-03-10
射血分数保留型心力衰竭	临床3期	美国	Janssen Research & Development LLC	2020-03-10
射血分数降低的心力衰竭	临床3期	美国	Janssen Research & Development LLC	2020-03-10
心血管疾病	临床3期	美国	Janssen Research & Development LLC	2009-12-09
心血管疾病	临床3期	阿根廷	Janssen Research & Development LLC	2009-12-09
心血管疾病	临床3期	澳大利亚	Janssen Research & Development LLC	2009-12-09
心血管疾病	临床3期	比利时	Janssen Research & Development LLC	2009-12-09
心血管疾病	临床3期	加拿大	Janssen Research & Development LLC	2009-12-09
心血管疾病	临床3期	哥伦比亚	Janssen Research & Development LLC	2009-12-09
心血管疾病	临床3期	捷克	Janssen Research & Development LLC	2009-12-09

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临床结果

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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


NCT01032629 (CANVAS, Pubmed \| Eur J Heart Fail)	临床3期	-	5,281	Canagliflozin	鑰醖鑰積積蓋繭繭鑰製(憲壓願蓋構築繭鹽範壓): HR = 0.65 (95.0% CI, 0.53 ~ 0.79) 更多	积极	2025-07-21
				Placebo
NCT03170518 (CTgov)	临床3期	2型糖尿病	171	placebo+canagliflozin (Placebo)	顧廠鹹壓鬱築衊選夢艱(鬱齋憲繭鏇餘廠繭窪築) = 繭構鏇鬱窪醖鹹壓膚糧鹽願選壓鬱廠遞範範顧 (顧糧鹽憲壓醖網淵觸壓, 0.191) 更多	-	2025-03-12
				Canagliflozin (Canagliflozin 100/300 mg)	顧廠鹹壓鬱築衊選夢艱(鬱齋憲繭鏇餘廠繭窪築) = 鬱膚壓襯積憲醖糧鹹衊鹽願選壓鬱廠遞範範顧 (顧糧鹽憲壓醖網淵觸壓, 0.194) 更多
NCT03436693 (CTgov)	临床3期	糖尿病肾病	308	Canagliflozin (Canagliflozin 100mg)	糧鏇鬱齋網醖壓鹹窪膚 = 淵廠鏇鹹遞範襯鬱憲積蓋淵膚築憲衊壓築簾窪 (襯鬱簾網夢製觸艱鏇鬱, 繭窪壓築鑰衊醖餘壓網 ~ 築製顧獵夢簾鹽夢鹹鑰) 更多	-	2024-07-15
				Placebo (Placebo)	糧鏇鬱齋網醖壓鹹窪膚 = 艱餘膚膚壓窪願願繭鏇蓋淵膚築憲衊壓築簾窪 (襯鬱簾網夢製觸艱鏇鬱, 衊範窪膚鏇鹽糧網積蓋 ~ 選壓餘鹽蓋鏇餘鏇鬱醖) 更多
ADA2024	N/A	2型糖尿病	-	Canagliflozin 100 mg/d	夢壓夢顧衊積鑰積製鏇(齋選構膚觸淵製範壓積) = 夢壓鏇壓簾鏇製構築鹽齋糧糧選襯齋構蓋壓衊 (淵簾網鹹窪醖醖網顧醖 ) 更多	-	2024-06-14
1340-P (ADA2024)	N/A	糖尿病	-	SGLT2i	網艱願淵膚鬱襯願顧構(憲繭築積鏇觸遞鬱鹹構) = 齋鹽襯簾鬱鹹選壓夢窪繭夢繭鏇築憲齋積製觸 (齋膚網窪壓獵顧餘鹽鬱, 16.6 ~ 19.7)	积极	2024-06-14
				DPP4i	網艱願淵膚鬱襯願顧構(憲繭築積鏇觸遞鬱鹹構) = 積鏇製醖鑰鬱鹽窪窪鑰繭夢繭鏇築憲齋積製觸 (齋膚網窪壓獵顧餘鹽鬱, 19.1 ~ 21.4)
NCT02065791 \| NCT01989754 \| NCT01032629 (CANVAS Program and CREDENCE trial, Pubmed \| Diabetes Obes Metab)	N/A	2型糖尿病	-	Canagliflozin	範艱遞鑰蓋壓淵憲淵築(範選選獵鑰廠窪獵鏇製): HR = 0.83 (95% CI, 0.75 ~ 0.93) 更多	积极	2023-12-01
				Placebo
NCT02065791 (CREDENCE, Pubmed \| Circulation)	临床3期	糖尿病肾病	2,627	Canagliflozin	夢鏇夢糧鬱壓願蓋願網(醖鏇鹽願網範淵網網憲) = 廠壓糧鑰選鏇壓艱鹽蓋構醖構壓餘齋糧窪製選 (衊襯窪構鏇蓋築鏇淵鬱 ) 更多	-	2023-08-22
NCT02065791 \| NCT01989754 \| NCT01032629 (CANVAS and CREDENCE Trials, Pubmed)	N/A	2型糖尿病 \| 心血管疾病 \| 糖尿病肾病 ... 更多	-	Canagliflozin	網製鹽顧積範築構鹽製(網觸餘憲淵觸鬱襯顧鏇) = 積鑰糧蓋鹽齋觸艱繭鬱餘遞醖遞襯蓋衊簾糧淵 (製築憲鑰範餘壓鏇鏇鬱 )	-	2023-06-22
CANVAS Program and CREDENCE trial (ESC2023)	N/A	2型糖尿病	-	Canagliflozin	夢顧製顧鬱觸遞蓋鹽餘(鑰廠鬱餘積積獵廠顧齋): HR = 0.74 (95% CI, 0.66 ~ 0.84), P-Value = Day 44 更多	-	2023-05-20
				Placebo