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2025-01-01

申办/合作机构

University Of Dundee

[+2]

NCT06618976 / Not yet recruiting临床4期IIT

SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.

开始日期2025-01-01

申办/合作机构

Icahn School of Medicine at Mount Sinai

NCT06510894 / Not yet recruitingN/AIIT

Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET

This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2) on myocardial glucose suppression on FDG PET/CT. The investigators will test whether the addition of a SGLT1/2 inhibitor (SGLT1/2i) plus the standard dietary modification (ketogenic diet) will provide enhanced myocardial glucose suppression. The primary objective is to assess rates of complete myocardial glucose suppression (MGS) with 7 days of sotagliflozin 400 mg QD among healthy volunteers on a background of 1 day (N=20) or 3 days (N=20) of the KD. The secondary goal is to investigate the relationship between sotagliflozin, targeted metabolite levels, and myocardial glucose utilization on FDG-PET.
Participants will be asked to:
* undergo a screening visit that includes blood tests, vitals, and questions regarding health history/medications
* take the provided sotagliflozin as instructed for 7 days leading up to the scan
* follow a ketogenic diet as instructed for 1 or 3 days leading up to the scan
* undergo an FDG PET/CT scan, which includes vitals and blood draws

开始日期2024-11-01

申办/合作机构

University of Pennsylvania

[+1]

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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196

项与索格列净相关的文献（医药）

2024-09-01·NEUROBIOLOGY OF DISEASE

Sotagliflozin attenuates cardiac dysfunction and depression-like behaviors in mice with myocardial infarction through the gut-heart-brain axis

Article

作者: Dai, Guangming ; Liao, Lei ; Feng, Ling ; Zhang, Lu ; Chang, Lijia ; Peng, Chendong ; Yang, Chengying ; Wang, Tong ; Wei, Yan ; Long, Yang ; Fan, Xinrong

Myocardial infarction (MI) and depression are leading causes of mortality and morbidity globally, and these conditions are increasing recognized as being fundamentally interconnected. The recently recognized gut-heart-brain axis offers insights into depression following MI, but effective treatments for this comorbidity remain lacking. To address this medical need, we employed an animal model of MI to investigate the potential repurposing of sotagliflozin (SOTA), an approved sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor for diabetes, for managing depression following MI and identifying potential SOTA-associated microbial mechanisms. SOTA treatment improved cardiac dysfunction and alleviated depression-like behaviors induced by MI, accompanied by alterations in gut microbiota composition, such as changes in the Prevotellaceae NK3B31 group, Alloprevotella, and Prevotellaceae UCG-001. Moreover, fecal microbiota transplantation (FMT) using fecal samples from SOTA-treated MI mice demonstrated that gut microbiota contributed to the beneficial effects of SOTA on cardiac dysfunction and depression-like behaviors in MI mice. Intriguingly, FMT-based intervention and concordance analysis of gut microbiota before and after FMT suggested that Prevotellaceae NK3B31 group, Alloprevotella, and Prevotellaceae UCG-001 were associated with the beneficial effects of SOTA. Furthermore, functional prediction of gut microbiota and correlation analysis support the significance of these dynamic microbial communities. In conclusion, these findings suggest that SOTA could serve as a potential drug to ameliorate cardiac dysfunction and depressive symptoms in MI patients via through the gut-heart-brain axis.

2024-09-01·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure

Article

作者: Bhatt, Ankeet S. ; Riddle, Matthew C ; Szarek, Michael ; Davies, Michael ; Steg, Ph Gabriel ; Wilcox, Christopher S ; Cannon, Christopher P. ; Testani, Jeffrey M. ; Kosiborod, Mikhail N ; Pitt, Bertram ; McGuire, Darren K ; Wilcox, Christopher S. ; Testani, Jeffrey M ; Leiter, Lawrence A. ; Bhatt, Deepak L ; Bhatt, Ankeet S ; Leiter, Lawrence A ; Cannon, Christopher P ; Voors, Adriaan A. ; Lund, Lars H ; Voors, Adriaan A ; Lund, Lars H. ; Bhatt, Deepak L. ; Lewis, Julia B. ; McGuire, Darren K. ; Kosiborod, Mikhail N. ; Lewis, Julia B ; Metra, Marco ; Riddle, Matthew C.

BACKGROUND:

Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve health status in heart failure (HF) across the left ejection fraction ejection spectrum. However, the effects of SGLT1 and SGLT2 inhibition on health status are unknown.

OBJECTIVES:

These prespecified analyses of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trial examined the effects of sotagliflozin vs placebo on HF-related health status.

METHODS:

SOLOIST-WHF randomized patients hospitalized or recently discharged after a worsening HF episode to receive sotagliflozin or placebo. The primary endpoint was total number of HF hospitalizations, urgent HF visits, and cardiovascular death. Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score was a prespecified secondary endpoint. This analysis evaluated change in the KCCQ-12 score from baseline to month 4.

RESULTS:

Of 1,222 patients randomized, 1,113 (91%) had complete KCCQ-12 data at baseline and 4 months. The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups. Sotagliflozin vs placebo reduced the risk of the primary endpoint consistently across KCCQ-12 tertiles (P_trend = 0.54). Sotagliflozin-treated patients vs those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change: 4.1 points; 95% CI: 1.3-7.0 points; P = 0.005). KCCQ-12 improvements were consistent across prespecified subgroups, including left ventricular ejection fraction <50% or ≥50%. More patients receiving sotagliflozin vs those receiving placebo had at least small (≥5 points) improvements in KCCQ-12 at 4 months (OR: 1.38; 95% CI: 1.06-1.80; P = 0.017).

CONCLUSIONS:

Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics. (Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure [SOLOIST-WHF]; NCT03521934).

2024-09-01·Diabetes technology & therapeutics

Beta-Hydroxybutyrate Levels and Risk of Diabetic Ketoacidosis in Adults with Type 1 Diabetes Treated with Sotagliflozin

Article

作者: Banks, Phillip ; Davies, Michael J. ; Boeder, Schafer ; Pratley, Richard ; McGill, Janet B. ; Girard, Manon ; Pettus, Jeremy ; Garg, Satish

Introduction: Sodium glucose cotransporter inhibitors may increase beta-hydroxybutyrate (BHB) in insulin-requiring patients. We determined factors associated with BHB changes from baseline (ΔBHB) and diabetic ketoacidosis (DKA) in patients with type 1 diabetes (T1D) receiving sotagliflozin as an insulin adjunct. Research Design and Methods: This post hoc analysis compared ΔBHB levels in adults with T1D receiving sotagliflozin 400 mg or placebo for 6 months. We evaluated clinical and metabolic factors associated with ΔBHB and used logistic regression models to determine predictors associated with BHB values >0.6 and >1.5 mmol/L (inTandem3 population; N = 1402) or with DKA events in a pooled analysis (inTandem1-3; N = 2453). Results: From baseline (median, 0.13 mmol/L), median fasting BHB increased by 0.04 mmol/L (95% confidence interval, 0.03-0.05; P < 0.001) at 24 weeks with sotagliflozin versus placebo; 67% of patients had no or minimal changes in BHB over time. Factors associated with on-treatment BHB >0.6 or >1.5 mmol/L included baseline BHB and sotagliflozin use. Age, insulin pump use, sotagliflozin use, baseline BHB, and ΔBHB were significantly associated with DKA episodes. Independent of treatment, DKA risk increased by 18% with each 0.1-mmol/L increase in baseline BHB and by 8% with each 0.1-mmol/L increase from baseline. Conclusion: Incremental increases in baseline BHB and ΔBHB were associated with a higher DKA risk independent of treatment. Adding sotagliflozin to insulin increased median BHB over 24 weeks in patients with T1D and was associated with increased DKA events. These results highlight the importance of BHB testing and monitoring and individualizing patient education on DKA risk, mitigation, identification, and treatment.

169

项与索格列净相关的新闻（医药）

2024-11-22

·GlobeNewswire-Health Care

Lexicon to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDA

Implementing Strategic Restructuring to Eliminate Commercial Organization and Rationalize Operations Across All Functions Prioritizing Strong R&D Pipeline Including Ongoing Studies in DPNP, HCM and Obesity Efforts Expected to Reduce 2025 Operating Costs by $100 Million Conference Call and Webcast at 9:00 am ET THE WOODLANDS, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the company has made the strategic decision to eliminate its commercial operations and rationalize resources across all functions in order to preserve cash and focus its resources on advancing its promising clinical development pipeline. This prioritization of investment is designed to advance the research and development programs that have the greatest potential for value creation and patient impact. This decision follows the receipt of a “deficiencies preclude discussion” letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The letter noted deficiencies with the application that preclude discussion of labeling and/or post-marketing requirements and commitments at this time. "While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy," said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. "We see significant potential in our strong pipeline of R&D opportunities, and we will focus our resources on programs with the potential for the greatest impact. We are confident that by carefully selecting therapeutic areas where we are the first and only therapy in class, and focusing our R&D efforts where there are significant needs, we can deliver innovations that will meaningfully benefit patients while simultaneously positioning Lexicon to fully realize future growth opportunities." Details of the Strategic Restructuring Complete elimination of the Company’s commercial field team and reduction in size of other functions across the organization, including the elimination of all promotional efforts for INPEFA® and all planned commercial activities for ZYNQUISTA.A total reduction of approximately 60 percent of employees, effective for most affected employees by December 31st.INPEFA to continue to be manufactured and made available to patients and existing prescribers.An expected reduction of 2025 full year operating costs by $100 million. This amount is in addition to the $40 million in expected 2025 cost savings announced in August as part of a realignment of resources. Reemerging as a Clinical Development-Focused Company Lexicon will concentrate its resources on the continued research and development of its strong pipeline, including: The Phase 2b PROGRESS study evaluating LX9211 in diabetic peripheral neuropathic pain (DPNP), with topline data anticipated in Q1 2025.The pivotal Phase 3 SONATA HCM study evaluating sotagliflozin in hypertrophic cardiomyopathy (HCM), with enrollment underway.IND-enabling studies of LX9851, a novel, non-incretin oral development candidate in obesity and associated cardiometabolic disorders.Advancing earlier stage opportunities for LX9211 and LX9851 in additional indications.Exploring strategic partnerships to advance and accelerate the value of our pipeline. Conference Call and Webcast InformationLexicon management will hold a live conference call and webcast today at 9:00 am ET / 8:00 am CT to review the details of this announcement. Participants can access the conference call live via webcast on the Events page of the Company’s website at https://www.lexpharma.com/media-center/events. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. An archived version of the webcast will be available on the website for 14 days. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, metabolism and other therapeutic areas. For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211, LX9851 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. Investor ContactLisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com Media ContactMolly DevlinReal Chemistrycorpcomm@lexpharma.com

申请上市临床2期临床3期

2024-11-22

·Endpoints

Lexicon ends commercial work to focus on R&D

Lexicon Pharmaceuticals is reverting to a clinical development company after facing repeated setbacks at the FDA for its type 1 diabetes and chronic kidney disease drug. The Texas biotech is slashing its commercial force and laying off about 60% of its employees as it switches its focus to R&D, the company said Friday morning. It’s the second round of cuts under recently appointed CEO Mike Exton. In August, the company said it was cutting about half of its sales and commercial teams, or about 75 people. Together, the two rounds of cuts are expected to slash operating costs by $140 million in 2025, Lexicon said. “While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy,” Exton said in a press release. Lexicon said the move was made after receiving a “deficiencies preclude discussion” letter from the FDA with regard to the company’s new drug application for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and CKD. Undisclosed deficiencies with the application “preclude discussion of labeling and/or post-marketing requirements and commitments at this time,” the company said. Last month, an FDA advisory committee voted against endorsing the benefit-risk profile of Lexicon’s SGLT2 inhibitor. It was the second such thumbs-down in five years. The company said while it’s eliminating its entire commercial field team, its drug Inpefa will still be manufactured and made available. Now, it will focus on R&D, with a Phase 2b readout in diabetic peripheral neuropathic pain expected in the first quarter of next year. It also has a Phase 3 testing sotagliflozin in hypertrophic cardiomyopathy. A non-incretin, oral obesity drug candidate is in IND-enabling studies. Exton previously led the cardiovascular and metabolic disease work at Novartis. The company said it is also looking at potential strategic partnerships for its pipeline. Lexicon had $258.4 million in cash and investments at the end of September. It recently inked a licensing deal with the generics company Viatris, which gets rights to sotagliflozin in all global regions outside the US and Europe. Viatris paid $25 million upfront and could dish out another $197 million in regulatory and sales milestones. The company also recently added former Eisai Alzheimer’s chief Ivan Cheung to its board.

临床2期引进/卖出高管变更临床3期

2024-11-22

·Firstwordpharma

Lexicon hunkers down on R&D after Zynquista's failure to launch

Lexicon Pharmaceuticals' diabetes hopeful Zynquista (sotagliflozin) has once again been shot down by the FDA — and this time, the drug developer is waving the white flag. The firm disclosed Friday that it has received a "deficiencies preclude discussion" letter from the FDA pointing out issues with its regulatory application that prevent any conversations regarding labelling for the drug, and/or post-marketing requirements.In light of the setback, Lexicon is closing down all commercialisation activities and slashing 60% of its workforce, effective Dec. 31, to preserve cash for ongoing R&D efforts.The strategic shift comes about five years after the US regulator first rejected Lexicon's bid for Zynquista as an adjunct to insulin in adults with type 1 diabetes (T1D), due to a potentially increased risk of diabetic ketoacidosis.While its second filing sought to improve the risk-benefit ratio by narrowing its focus to patients with T1D and chronic kidney disease, some safety concerns remained. The drug received a negative vote from an FDA advisory committee last month, with one member, NIH's Martha Nason, voicing concerns over the supporting data showing "too much uncertainty about potentially fatal consequences."Now, the company is turning its focus towards its late-stage development pipeline. Investors reacted positively to the strategic shift, boosting the company's shares up over 10% Friday afternoon. Coming up through the pipelineAlthough Lexicon did notch a win last year for sotagliflozin when it was approved as Inpefa for patients with heart failure, Friday's reprioritisation will see it also wind down all promotional efforts for the the oral SGLT2/1 inhibitor in the indication and completely eliminate its commercial field team. The company noted that Inpefa will continue to be manufactured and available to patients.The changes are expected to reduce operating costs by $100 million next year, in addition to $40 million that it expects to save from an earlier round of layoffs, announced in August, that affect 75 staffers. With its streamlined operations, Lexicon plans to focus on a pair of clinical programmes: the Phase IIb PROGRESS study of LX9211, an AAK1-targeting oral small molecule in diabetic peripheral neuropathic pain, and the pivotal Phase III SONATA HCM trial of sotagliflozin to treat hypertrophic cardiomyopathy.Topline data from PROGRESS are expected in the first quarter of 2025; enrollment is underway for SONATA HCM. Lexicon is also conducting IND-enabling studies of LX9851, a non-incretin oral candidate, in obesity and associated cardiometabolic disorders.

临床2期临床3期上市批准

100 项与索格列净相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D10669	索格列净	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
非梗阻性肥厚型心肌病	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2024-09-24
梗阻性肥厚型心肌病	临床3期	美国	Lexicon Pharmaceuticals, Inc.	2024-09-24
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	美国	Sanofi	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	加拿大	Sanofi	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	Sanofi	2015-09-01

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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


Pubmed 人工标引	N/A	1型糖尿病 \| 慢性肾病	-	Sotagliflozin 200mg (CKD)	衊夢簾製簾鏇艱構顧網(糧齋構鏇繭範鬱鑰夢膚) = 淵憲淵鹽網膚鹹廠艱獵齋繭淵鬱淵願淵積廠鬱 (鹹築壓蓋顧壓壓繭醖糧 ) 更多	积极	2024-11-01
				Sotagliflozin 400mg (CKD)	衊夢簾製簾鏇艱構顧網(糧齋構鏇繭範鬱鑰夢膚) = 齋積鹹醖鑰鹹壓築製積齋繭淵鬱淵願淵積廠鬱 (鹹築壓蓋顧壓壓繭醖糧 ) 更多
NCT03285594 (SOTA-INS, GlobeNewswire) 人工标引	临床3期	2型糖尿病	-	Sotagliflozin 400 mg	積觸廠衊醖製觸憲廠壓(膚築淵窪構壓繭艱衊構) = 積簾膚夢窪糧鑰顧鹽遞夢積醖積製願憲餘願鑰 (築夢鬱築遞鑰蓋壓鏇衊 )	积极	2024-09-10
				Sotagliflozin 200 mg	積觸廠衊醖製觸憲廠壓(膚築淵窪構壓繭艱衊構) = 衊積壓膚網遞鑰願膚鏇夢積醖積製願憲餘願鑰 (築夢鬱築遞鑰蓋壓鏇衊 )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	临床3期	2型糖尿病 \| 心脏衰竭	-	Sotagliflozin	蓋繭鏇選齋鏇獵構選觸(艱糧襯觸壓醖淵顧遞餘) = The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups 衊繭淵餘壓膚衊艱壓顧 (築夢顧齋衊齋艱憲鹽範 )	积极	2024-09-01
				Placebo
ESC2024	N/A	糖尿病	-	Sotagliflozin	蓋遞簾夢艱糧築遞膚鹽(鏇衊獵齋網獵壓淵網糧) = 願糧簾憲遞廠糧壓鑰顧製鹽顧簾獵窪膚簾蓋餘 (夢顧窪觸糧網窪觸鹽醖 ) 更多	-	2024-08-30
				Placebo	蓋遞簾夢艱糧築遞膚鹽(鏇衊獵齋網獵壓淵網糧) = 繭顧網獵積繭觸範糧製製鹽顧簾獵窪膚簾蓋餘 (夢顧窪觸糧網窪觸鹽醖 ) 更多
924-P (ADA2024)	临床3期	2型糖尿病追加	570	Sotagliflozin 400 mg	鹹製淵鬱觸衊鹹夢積糧(齋顧淵壓獵觸範鹽廠顧) = 廠鬱廠積鹹鬱繭製積顧襯鹹繭製衊網蓋網選願 (構衊鬱廠繭願壓廠鏇衊 )	积极	2024-06-14
				Sotagliflozin 200 mg	鹹製淵鬱觸衊鹹夢積糧(齋顧淵壓獵觸範鹽廠顧) = 壓艱窪鬱壓網餘衊衊選襯鹹繭製衊網蓋網選願 (構衊鬱廠繭願壓廠鏇衊 )
917-P (ADA2024)	临床3期	2型糖尿病	770	Sotagliflozin 400 mg	製壓構艱糧夢築廠夢鹽(廠獵遞壓艱製壓製鑰獵) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy 鹽憲鹽築築膚築衊膚網 (窪簾獵膚壓窪遞鑰選壓 ) 更多	积极	2024-06-14
				Empagliflozin 25 mg
SCORED (GlobeNewswire) 人工标引	临床3期	心脏衰竭	1,932	INPEFA® (sotagliflozin)	築積襯醖築淵觸壓襯蓋(壓鏇構窪淵獵窪憲鬱膚) = 艱夢製艱餘簾鬱壓獵衊遞夢觸網淵選艱齋夢鏇 (襯膚網齋蓋範窪餘醖醖 )	积极	2024-05-14
SOLOIST-WHF and SCORED (ESC2024)	N/A	obesity \| type 2 diabetes (T2D)	-	Sotagliflozin	觸鏇範鏇壓淵廠鹽遞憲(糧簾製顧鹽鏇淵網壓鑰) = 願蓋願醖鏇獵繭築遞鬱醖構鏇蓋壓範糧憲選鬱 (獵構餘淵窪顧簾糧簾鹹 )	积极	2024-05-14
NCT03315143 (SCORED, ACC2024) 人工标引	临床3期	心血管疾病 \| 2型糖尿病 \| 慢性肾病	10,584	Sotagliflozin	鑰網膚壓醖繭憲願製廠(築獵餘築鏇壓齋觸鬱選) = 網觸觸蓋選淵鑰鬱築鬱鏇觸簾鏇製壓鹽鏇廠齋 (製壓獵網遞製蓋壓衊遞 ) 更多	积极	2024-03-25
				Placebo	鑰網膚壓醖繭憲願製廠(築獵餘築鏇壓齋觸鬱選) = 築鏇憲顧壓鹽鹹齋網壓鏇觸簾鏇製壓鹽鏇廠齋 (製壓獵網遞製蓋壓衊遞 ) 更多
SCORED (GlobeNewswire) 人工标引	N/A	心脏衰竭	-	INPEFA	鹹獵襯鹽網顧觸憲鹹簾(鬱餘憲齋鹹壓夢齋醖齋) = 願糧鏇選廠窪鏇選製夢艱膚衊獵窪構窪鏇醖範 (鬱蓋鹽糧壓積襯遞壓積 ) 更多	积极	2023-11-12
				placebo	-