索格列净(Sotagliflozin) - 药物靶点：SGLT1 x SGLT2_在研适应症：心脏衰竭，慢性肾病，1型糖尿病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

sotagliflozin、Sotagliflozin (USAN/INN)、LP-802034

+ [6]

靶点

SGLT1 x SGLT2

作用机制

SGLT1抑制剂(钠-葡萄糖协同转运蛋白-1抑制剂)、SGLT2抑制剂(钠-葡萄糖协同转运蛋白-2抑制剂)

治疗领域

免疫系统疾病心血管疾病内分泌与代谢疾病+ [1]

在研适应症

心脏衰竭慢性肾病1型糖尿病+ [1]

非在研适应症

非胰岛素依赖型糖尿病22型糖尿病高血糖+ [2]

原研机构

NCI Healthcare LLC

在研机构

Lexicon Pharmaceuticals, Inc.

非在研机构

Sanofi

赛诺菲（中国）投资有限公司

NCI Healthcare LLC

+ [1]

最高研发阶段批准上市

首次获批日期

欧盟 (2019-04-26),

1型糖尿病

最高研发阶段(中国)终止

特殊审评-

登录后查看首次获批时间轴

结构

分子式C21H25ClO5S

InChIKeyQKDRXGFQVGOQKS-CRSSMBPESA-N

CAS号1018899-04-1

关联

48

项与索格列净相关的临床试验

NCT06147232 / Not yet recruiting临床4期

Prevention of CKD Progression in Type 1 Diabetes With Long Term Use of SGLTi Avoiding Kidney hypOxia(PLUTO)

Background: Sodium-glucose-cotransporter (SGLT) inhibition has been observed to reduce risk of cardiovascular events and kidney failure in persons with type 2 diabetes. People with type 1 diabetes also have increased risk of cardiovascular and kidney disease, and may benefit from SGLT-inhibition. The exact mechanism of how SGLT-inhibition benefits the kidneys are yet unknown. Change in renal hypoxia may be a factor.
Objective: The primary aim of this study is to assess the effects of 12 weeks SGLT-1 and 2 inhibition on renal oxygenation in persons with type 1 diabetes and chronic kidney disease.
Further aims are to study if renal oxygen consumption and response to SGLT-inhibition differs between people of African-Caribbean or Northern European decent.
Additionally effects on left ventricular ejection fraction, kidney function and biomarkers in blood and urine will be explored.
Method: 12 weeks treatment with oral sotagliflozin or matching placebo as intervention. Kidney oxygenation and perfusion parameters and left ventricular ejection fraction will be assessed by functional magnetic resonance imaging. Kidney function and biomarkers will be assessed according to local hospital laboratory guidelines.
Design: Randomized, double-blinded, placebo-controlled, cross over intervention study.
Study population: 69 persons with type 1 diabetes and diabetic kidney disease with albuminuria will be included, 39 at Steno Diabetes Center Copenhagen, 30 at King's College London.
Endpoints: Primary end-point: Change from 0 to 12 weeks in dynamic R2*-weighted signal after treatment with sotagliflozin compared to placebo. Secondary endpoints: Change from 0 to 12 weeks with sotagliflozin compared with placebo on renal perfusion, renal artery flow, renal oxygen consumption, renal parenchymal triglyceride fraction, renal fibrosis, left ventricular ejection fraction, urinary albumin-creatinin ratio, ketone bodies, erythropoietin, pro brain natriuretic peptide, and plasma- and urine inflammation- and fibrosis biomarkers as well as difference after 12 weeks treatment in glomerular filtration rate.
Timeframe: Inclusion of patients from february 2024. Last visit september 2025. Presentation spring 2026, publication fall 2026.

开始日期2024-08-01

申办/合作机构

Steno Diabetes Center A/S

[+3]

NCT06435156 / Not yet recruiting临床2期IIT

A Phase 2 Double-blind Randomised Controlled Trial Studying the Effect of Sotagliflozin Versus Placebo in Individuals With Heart Failure and Type 1 Diabetes.

People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population.
In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients' symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that it is not known if these benefits also apply to this population.
This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (UK). This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.

开始日期2024-07-01

申办/合作机构

University Of Dundee

[+2]

ISRCTN79322795 / Recruiting临床2期IIT

A phase 2 double-blind randomised controlled trial studying the effect of sotagliflozin 200mg once daily versus placebo in individuals with heart failure and type 1 diabetes on quality of life measured using the Kansas City Cardiomyopathy Questionnaire

开始日期2024-06-30

申办/合作机构

University Of Dundee

100 项与索格列净相关的临床结果

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100 项与索格列净相关的转化医学

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100 项与索格列净相关的专利（医药）

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181

项与索格列净相关的文献（医药）

2024-05-01·The Annals of pharmacotherapy

The Impact of SGLT2 Inhibitors on Cardiovascular Outcomes in Patients With Heart Failure With Preserved Ejection Fraction

Review

作者: Pinner, Nathan A. ; Starr, Jessica A.

Objective:

To evaluate the role of sodium-glucose cotransporter-2 (SGLT2) inhibitors in patients with heart failure with preserved ejection fraction (HFpEF).

Data sources:

A literature search of PubMed, the Cochrane Library, and Google Scholar databases (January 2015 to June 20, 2023) was performed with keywords: sodium-glucose co-transporter 2 inhibitors OR SGLT2 inhibitors OR bexagliflozin OR canagliflozin OR dapagliflozin OR empagliflozin OR ertugliflozin OR sotagliflozin AND heart failure OR heart failure with preserved ejection fraction, and terms related to CV outcomes including cardiovascular death, hospitalization, hospitalization for heart failure, mortality, death, and major adverse cardiovascular event (MACE).

Study selection and data extraction:

The reference list from retrieved articles as well as relevant review articles was considered. Pivotal randomized controlled trials and meta-analyses with a primary or secondary end point of CV death or heart failure hospitalization were included. Studies conducted solely in a diabetic patient population were excluded.

Data synthesis:

Dapagliflozin and empagliflozin, in a broad population of heart failure patients including, HFrEF, HFmrEF, HFpEF, and without diabetes, have shown consistent improvement in the combined outcome of CV death and hospitalization for heart failure (HR 0.80, 95% CI 0.73-0.87) and in the reduction of heart failure hospitalizations (HR 0.74, 95% CI 0.67-0.83). In patients with HFpEF, cardiovascular mortality was not demonstrated (HR 0.88, 95% CI 0.77-1.00). Rates of adverse events were low.

Relevance to patient care and clinical practice:

Patients with HFpEF and NYHA class II-III with frequent symptoms or hospitalizations for heart failure derive the most benefit from SGLT2 inhibitors with an overall goal of a reduction in heart failure hospitalizations.

Conclusions:

The treatment of HFpEF has made progress, but there is still work to be done. Now, SGLT2 inhibitor therapy can be used to further help with symptom control and reduce overall hospitalizations for heart failure.

2024-02-01·Diabetes, obesity & metabolism

Effect of the dual sodium‐glucose co‐transporter‐1 and ‐2 inhibitor sotagliflozin on renal outcomes in type 1 diabetes and type 2 diabetes: A systematic review and meta‐analysis of randomized controlled trials

Review

作者: Bantounou, Maria Anna ; Philip, Sam ; Mahmood, Ribeya ; Black Boada, Daniel ; Kaczmarek, Justyna ; Thuemmler, Rosa ; Sardellis, Panagiotis ; Plascevic, Josip

Abstract:

Aim:

To investigate the renal safety profile of sotagliflozin, a novel sodium‐glucose co‐transporter‐1 and ‐2 inhibitor, in patients with type 1 diabetes and type 2 diabetes, with or without renal impairment, as well as its efficacy in decreasing the risk of further renal events, with an emphasis on those with previous renal impairment.

Methods:

Embase, Medline, CENTRAL and Scopus were searched from their inception until 24 April 2023 for randomized controlled trials that reported estimated glomerular filtration rate (eGFR), urinary albumin excretion or composite renal events (CRE). The Cochrane risk of bias 2 tool was used. Mean difference, relative risk (RR) and 95% confidence intervals were estimated (PROSPERO: CRD42023425583).

Results:

Fourteen studies were included in this review (n = 17 574 participants; intervention n = 9312, control n = 8262). The median follow‐up was 24.5 (Q1 = 15.25, Q3 = 28) months. Four studies recruited participants with renal impairment; baseline eGFR ranged from 23.8 to 50.5 mL/min/1.73m2. The change in eGFR for studies (n = 6) with a follow‐up of 52 weeks or longer was −1.23 (−1.45, −1.01) mL/min/1.73m2. Sotagliflozin did not significantly alter urinary albumin excretion. No change was observed in the risk of CRE (n = 6 studies; RR = 0.82 [0.61, 1.12]), including in participants with renal impairment. High risk of bias was a limitation of this review.

Conclusions:

Sotagliflozin did not adversely affect renal function or change the risk of key renal outcomes, including for participants with pre‐existing renal impairment. Therefore, sotagliflozin was safe; however, further research is needed to determine its efficacy in reducing the risk of diabetic kidney disease.

2024-01-01·Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis

Blockade of sodium–glucose co-transporters improves peritoneal ultrafiltration in uraemic rodent models

Article

作者: Neulander, Endre Z ; Shnaider, Alla ; Basok, Anna ; Vorobiov, Marina ; Chaimowitz, Cidio ; Haviv, Yosef-Shmuel ; Douvdevani, Amos ; Riff, Reut ; Rogachev, Boris

Background::

The most used PD fluids contain glucose as a primary osmotic agent. Glucose peritoneal absorption during dwell decreases the osmotic gradient of peritoneal fluids and causes undesirable metabolic consequences. Inhibitors of sodium–glucose co-transporter (SGLT) type 2 are wildly used for the treatment of diabetes, heart and kidney failure. Previous attempts to use SGLT2 blockers in experimental peritoneal dialysis yielded contrasting results. We studied whether peritoneal SGLTs blockade may improve ultrafiltration (UF) via partial inhibition of glucose uptake from dialysis fluids.

Methods::

Kidney failure was induced in mice and rats by bilateral ureteral ligation, and dwell was performed by injection of glucose-containing dialysis fluids. The effect of SGLT inhibitors on glucose absorption during fluid dwell and UF was measured in vivo.

Results::

Diffusion of glucose from dialysis fluid into the blood appeared to be sodium-dependent, and blockade of SGLTs by phlorizin and sotagliflozin attenuated blood glucose increment thereby decreasing fluid absorption. Specific SGLT2 inhibitors failed to reduce glucose and fluid absorption from the peritoneal cavity in a rodent kidney failure model.

Conclusions::

Our study suggests that peritoneal non-type 2 SGLTs facilitate glucose diffusion from dialysis solutions, and we propose that limiting glucose reabsorption by specific SGLT inhibitors may emerge as a novel strategy in PD treatment to enhance UF and mitigate the deleterious effects of hyperglycaemia.

129

项与索格列净相关的新闻（医药）

2024-07-01

·Pharma CMC

累计投入超4亿！恒瑞医药「脯氨酸恒格列净片」新适应症获批

6月30日晚，恒瑞医药发布公告，公司以化学药品2.4类申报的脯氨酸恒格列净片新适应症获批，“与盐酸二甲双胍和磷酸瑞格列汀联合使用：在单独使用盐酸二甲双胍血糖控制不佳时，本品可与盐酸二甲双胍和磷酸瑞格列汀联合使用，配合饮食和运动改善成人2型糖尿病患者的血糖控制”。据悉，这是脯氨酸恒格列净片获批的第2个适应症，该适应症的获批使得脯氨酸恒格列净成为目前中国唯一获批与二肽基肽酶-IV（DPP-IV）抑制剂和二甲双胍联合治疗方案的钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂。脯氨酸恒格列净是恒瑞医药自主研发的新型SGLT2抑制剂，通过减少肾小管滤过的葡萄糖的重吸收，从而增加尿糖排泄，是“十二五”国家科技重大专项中糖尿病领域唯一获批上市的1类化学创新药。脯氨酸恒格列净创新性地引入F原子和L-脯氨酸基团，提高药物稳定性和药物的生物活性，已纳入2023版国家医保目录。 2021年12月，恒瑞医药的脯氨酸恒格列净片获批上市，适用于改善成人2型糖尿病患者的血糖控制。单药可配合饮食控制和运动，改善成人2型糖尿病患者的血糖控制；在单独使用盐酸二甲双胍血糖控制不佳时，可与盐酸二甲双胍联合使用，配合饮食和运动改善成人2型糖尿病患者的血糖控制。全球范围内的SGLT2抑制剂上市产品包括阿斯利康的达格列净、强生的卡格列净、勃林格殷格翰的恩格列净、默沙东的埃格列净和赛诺菲的索格列净等。据悉，SGLT2抑制剂相关产品2023年全球销售额合计约155.68亿美元。截至目前，恒瑞医药的脯氨酸恒格列净片相关项目累计已投入研发费用约40,813万元。

上市批准

2024-06-29

·佰傲谷BioValley

搁置5年后，再次提交上市申请

近日，Lexicon Pharmaceuticals公司宣布，已重新提交其SGLT1/SGLT2的双重抑制剂sotagliflozin作为1型糖尿病患者胰岛素辅助疗法的上市申请。这距离Lexicon上一次提交该适应症的上市申请已经过去了5年。有效但安全欠佳 Sotagliflozin最初由Lexicon开发，是一种口服1型和2型钠葡萄糖共转运蛋白SGLT1/SGLT2双重抑制剂，SGLT1负责胃肠道中的葡萄糖吸收，而SGLT2负责肾脏对葡萄糖的重吸收，对SGLT1/SGLT2的双重抑制可抑制消化道对葡萄糖和半乳糖的吸收以及肾小管对葡萄糖的重吸收。 2019年4月，Sotagliflozin首次获得欧盟委员会批准上市（商品名为Zynquista），作为胰岛素治疗的辅助药物，用于体重指数≥27kg/m2且接受胰岛素疗法仍无法达到足够血糖控制的1型糖尿病成人患者，这使其也成为首个治疗1型糖尿病的口服药。不过，Sotagliflozin没能叩开美国的大门，2019年3月，Lexicon收到FDA发出拒绝批准的CRL信函，原因是，FDA认为相比胰岛素，接受Sotagliflozin+胰岛素联合治疗的患者糖尿病酮症酸中毒（DKA）风险显著增加（3.0% vs 0.6%）。这直接导致合作伙伴的退出。在2015年11月，赛诺菲与Lexicon达成独家授权协议，获得了Sotagliflozin除日本区以外的全球独家权益。为此，赛诺菲向Lexicon支付了3亿美元的首付款，未来里程碑金额高达14亿美元，Lexicon还有资格获得一定比例的销售分成。Lexicon负责对1型糖尿病的临床开发，赛诺菲则负责针对2型糖尿病的临床开发。在遭拒的几个月后，赛诺菲便宣布与Lexicon终止sotagliflozin上的合作。赛诺菲给出的理由是，在治疗伴有中度和重度慢性肾脏病（CKD）的Ⅱ型糖尿病患者中开展的2项III期研究（SOTA-CKD3、SOTA-CKD4）中，Sotagliflozin没有达到其预期。事实上，FDA对多款SGLT抑制剂类药物申请治疗1型糖尿病的批准也采取了一样的态度，2019年7月，阿斯利康的SGLT2抑制剂Farxiga治疗1型糖尿病的上市申请也被FDA拒绝批准。2019年11月，FDA内分泌和代谢药物咨询委员会以14:2的结果“拒绝”了勃林格殷格翰/礼来的SGLT2抑制剂Jardiance用于1型糖尿病的上市申请。顺利转心衰相比1型糖尿病，FDA在批准另外一个适应症上就宽松许多。 SGLT2抑制剂在作为降糖药开发的同时，也被意外发现对心力衰竭有预防和治疗作用，Farxiga、Jardiance等多款SGLT2抑制剂均成功获得了FDA的批准。有赖于多款SGLT2抑制剂在临床获益，加上Sotagliflozin还带来了已上市的SGLT2抑制剂未能体现的降低中风和心梗事件发生风险上的益处。2023年5月，sotagliflozin成功获得FDA批准，用于治疗心衰。可以说，这个监管批准也是出乎意料之外的。 Lexicon递交上市申请的两项临床试验（SOLOIST和SCORED）中入组对象都仅限于2型糖尿病患者，但FDA对sotagliflozin的批准范围中对是否为糖尿病患者未做约束，也未限制左心室射血分数。这表明FDA充分认可Sotagliflozin给心衰患者带来的获益的。总结至今，仍未有一款SGLT1/2抑制剂获得FDA批准治疗1型糖尿病的批准，除了Sotagliflozin之外，这5年间，阿斯利康和礼来/的SGLT2抑制剂似乎也都没有再提及治疗的1型糖尿病的打算，那么，这次FDA会放低门槛通过吗？参考出处 https://endpts.com/lexicon-resubmits-type-1-diabetes-drug-to-fda-five-years-after-rejection/ https://www.lexpharma.com/media-center/news/2024-06-21-lexicon-pharmaceuticals-resubmits-sotagliflozin-nda-for-type-1-diabetes心衰新药4年等来FDA上市绿灯 |第一现场本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

引进/卖出医药出海上市批准临床3期突破性疗法

2024-06-24

·药明康德

治疗糖尿病，双重SGLT抑制剂递交新药申请

Lexicon Pharmaceuticals今日宣布，在与美国FDA进行多次沟通后，已重新提交在研疗法sotagliflozin的新药申请（NDA），作为胰岛素的辅助疗法，帮助1型糖尿病伴有慢性肾病（CKD）患者控制血糖。 Sotagliflozin是1型和2型钠葡萄糖共转运蛋白（SGLT1和SGLT2）的口服抑制剂。SGLT1主要负责在胃肠道对葡萄糖的吸收，而SGLT2主要负责在肾脏对葡萄糖的重吸收。抑制这两种蛋白的功能可以让更多葡萄糖从尿液中排出，并且降低食物中葡萄糖的吸收，从而帮助1型糖尿病患者控制血糖水平。它在2019年获得欧盟委员会批准上市，商品名为Zynquista。去年5月，它获得美国FDA的批准，用于降低成人患者的心血管死亡、因心力衰竭而住院或接受急救的风险。这些患者患有心力衰竭，或患有2型糖尿病、慢性肾病，并携带其它心血管疾病风险因子。 Sotagliflozin在欧盟的批准是基于名为inTandem的临床试验项目，它包括3项3期临床试验，在接近3000名1型糖尿病患者中检验其有效性和安全性。试验结果表明，sotagliflozin在24周时与基线相比，能够显著降低患者的糖化血红蛋白、体重、和收缩压水平。与胰岛素单药疗法相比，显著改善患者血糖水平区间和患者报告结果。参考资料： [1] Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes. Retrieved June 21, 2024, from https://www.lexpharma.com/media-center/news/2024-06-21-lexicon-pharmaceuticals-resubmits-sotagliflozin-nda-for-type-1-diabetes 内容来源于网络，如有侵权，请联系删除。

引进/卖出医药出海上市批准

100 项与索格列净相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10669	-	A10BK06	DB12713

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
心脏衰竭	美国	Lexicon Pharmaceuticals, Inc.	2023-05-26
1型糖尿病	欧盟	NCI Healthcare LLC	2019-04-26
1型糖尿病	冰岛	NCI Healthcare LLC	2019-04-26
1型糖尿病	列支敦士登	NCI Healthcare LLC	2019-04-26
1型糖尿病	挪威	NCI Healthcare LLC	2019-04-26

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
慢性肾病	申请上市	美国	Lexicon Pharmaceuticals, Inc.	2024-06-21
2型糖尿病	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2016-11-01
2型糖尿病	临床3期	加拿大	Lexicon Pharmaceuticals, Inc.	2016-11-01
2型糖尿病	临床3期	匈牙利	Lexicon Pharmaceuticals, Inc.	2016-11-01
2型糖尿病	临床3期	斯洛伐克	Lexicon Pharmaceuticals, Inc.	2016-11-01
高血糖	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2015-09-01
高血糖	临床3期	阿根廷	Lexicon Pharmaceuticals, Inc.	2015-09-01
高血糖	临床3期	澳大利亚	Lexicon Pharmaceuticals, Inc.	2015-09-01
高血糖	临床3期	比利时	Lexicon Pharmaceuticals, Inc.	2015-09-01
高血糖	临床3期	保加利亚	Lexicon Pharmaceuticals, Inc.	2015-09-01

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临床结果

适应症

分期

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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


SCORED (GlobeNewswire) 人工标引	临床3期	心脏衰竭	1,932	INPEFA® (sotagliflozin)	鬱鹽衊鹹製憲簾醖夢襯(衊鏇鹹膚獵壓繭積憲醖) = 製獵憲鑰襯壓遞選膚憲積選鏇襯繭衊襯蓋糧獵 (壓鏇鹹網蓋積夢繭齋廠 )	积极	2024-05-14
NCT03315143 (SCORED, ACC2024) 人工标引	临床3期	2型糖尿病 \| 慢性肾病 \| 心血管疾病	10,584	Sotagliflozin	鑰遞鬱簾網鹽鹽廠簾衊(築網窪餘餘觸窪願構蓋) = 遞網憲襯簾願蓋膚積壓夢築簾製餘窪鑰淵繭淵 (衊醖餘憲糧鏇憲鏇構獵 ) 更多	积极	2024-03-25
				Placebo	鑰遞鬱簾網鹽鹽廠簾衊(築網窪餘餘觸窪願構蓋) = 夢築繭壓蓋憲憲範築鏇夢築簾製餘窪鑰淵繭淵 (衊醖餘憲糧鏇憲鏇構獵 ) 更多
SCORED (GlobeNewswire) 人工标引	N/A	心脏衰竭	-	INPEFA	蓋鏇齋遞積餘網網範襯(願壓鏇繭廠選衊範繭簾) = 願鑰夢顧遞夢糧壓鏇餘範簾築遞衊糧繭窪鑰範 (範窪繭膚衊糧選顧顧願 ) 更多	积极	2023-11-12
				placebo	-
NCT02531035 (inTandem 3, EASD2023)	临床3期	1型糖尿病 BHB \| A1C \| UGE ... 更多	1,402	Sotagliflozin 400 mg/d	餘簾鹽築積鬱構淵蓋糧(鹽艱廠鹹獵獵鏇膚簾網) = 獵醖衊蓋簾構糧構廠餘蓋積願獵廠廠構願積壓 (繭積獵鬱選顧襯糧襯艱 ) 更多	积极	2023-10-03
				Placebo	餘簾鹽築積鬱構淵蓋糧(鹽艱廠鹹獵獵鏇膚簾網) = 鹽獵蓋餘壓簾遞範鏇艱蓋積願獵廠廠構願積壓 (繭積獵鬱選顧襯糧襯艱 )
NCT03315143 (SCORED, FDA) 人工标引	临床3期	心脏衰竭	10,584	INPEFA	壓壓範餘廠鏇蓋積鏇糧(夢遞築襯衊積醖製鏇網) = 觸鏇鏇構壓築襯鹽襯壓範遞簾鑰築蓋觸鬱積壓 (齋範窪鏇壓廠壓淵夢艱 ) 更多	积极	2023-05-26
				Placebo	壓壓範餘廠鏇蓋積鏇糧(夢遞築襯衊積醖製鏇網) = 壓鑰夢鑰繭糧艱願選鏇範遞簾鑰築蓋觸鬱積壓 (齋範窪鏇壓廠壓淵夢艱 ) 更多
NCT03521934 (SOLOIST, FDA) 人工标引	临床3期	心脏衰竭	1,222	INPEFA	構齋餘醖齋淵膚窪鹹願(廠簾獵願顧網膚網膚構) = 齋網膚壓製艱艱獵夢艱鏇觸鹽築製繭糧遞淵醖 (製艱憲壓壓夢憲築範網 ) 更多	积极	2023-05-26
				Placebo	構齋餘醖齋淵膚窪鹹願(廠簾獵願顧網膚網膚構) = 廠鏇鏇鬱衊餘膚鹹觸窪鏇觸鹽築製繭糧遞淵醖 (製艱憲壓壓夢憲築範網 ) 更多
SOLOIST-WHF (ESC2023)	临床3期	心脏衰竭	1,222	Sotagliflozin	遞顧襯蓋構廠艱鹽獵鬱(壓繭繭鏇製鏇憲顧製觸) = 鏇糧餘獵繭製鬱顧醖遞選繭構鹽淵衊壓齋夢膚 (夢獵壓鏇憲鹽鏇繭憲衊 ) 更多	-	2023-05-20
				Placebo	遞顧襯蓋構廠艱鹽獵鬱(壓繭繭鏇製鏇憲顧製觸) = 鑰憲製觸衊築艱壓鬱醖選繭構鹽淵衊壓齋夢膚 (夢獵壓鏇憲鹽鏇繭憲衊 ) 更多
NCT03242252 (Pubmed)	临床3期	2型糖尿病 \| 慢性肾病	787	Sotagliflozin 200 mg	壓艱襯鏇選觸襯範製齋(獵範鹹糧膚繭蓋壓鬱簾) = 築獵齋製壓艱蓋築淵觸糧壓顧範願蓋淵繭築蓋 (簾鬱鬱範製範齋鏇窪觸, -0.2 ~ 0.05)	-	2023-02-13
				Sotagliflozin 400 mg	壓艱襯鏇選觸襯範製齋(獵範鹹糧膚繭蓋壓鬱簾) = 鬱鑰鏇鏇餘築鏇齋襯窪糧壓顧範願蓋淵繭築蓋 (簾鬱鬱範製範齋鏇窪觸, -0.4 ~ -0.09)
Phase 3 (ASN2022)	临床3期	2型糖尿病 eGFR \| UACR	-	Sotagliflozin (SOTA)	衊範鏇鏇膚鏇憲構襯淵(製衊網襯願遞觸顧窪夢) = 憲鏇襯顧鏇簾廠窪憲積膚鏇窪顧齋齋壓鹽願製 (夢願選網製憲醖廠簾選, -23.4 ~ -19.1)	积极	2022-11-05
inTandem trials (ASN2022)	N/A	1型糖尿病	2,977	Sotagliflozin 200 mg	壓鏇襯艱憲蓋淵獵壓獵(壓範憲襯襯顧繭蓋繭遞) = 製繭廠廠蓋憲鑰顧鏇蓋淵餘糧餘繭觸鏇齋蓋壓 (夢醖積襯淵繭夢繭醖遞 )	积极	2022-11-05
				Sotagliflozin 400 mg	壓鏇襯艱憲蓋淵獵壓獵(壓範憲襯襯顧繭蓋繭遞) = 糧製築餘蓋簾夢簾積積淵餘糧餘繭觸鏇齋蓋壓 (夢醖積襯淵繭夢繭醖遞 )