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.

Start Date01 Jan 2025

Sponsor / Collaborator

University Of Dundee

[+2]

NCT06510894 / Not yet recruitingNot ApplicableIIT

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

Start Date01 Nov 2024

Sponsor / Collaborator

University of Pennsylvania

[+1]

NCT06217302 / Not yet recruitingPhase 3IIT

Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease

Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.

Start Date15 Oct 2024

Sponsor / Collaborator

Joslin Diabetes Center, Inc.

[+24]

100 Clinical Results associated with Sotagliflozin

100 Translational Medicine associated with Sotagliflozin

100 Patents (Medical) associated with Sotagliflozin

200

Literatures (Medical) associated with Sotagliflozin

01 Sep 2024·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

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

Article

Author: Bhatt, Ankeet S. ; Riddle, Matthew C ; Szarek, Michael ; Davies, Michael ; Wilcox, Christopher S ; Steg, Ph Gabriel ; Cannon, Christopher P. ; Kosiborod, Mikhail N ; Testani, Jeffrey M. ; Pitt, Bertram ; McGuire, Darren K ; Wilcox, Christopher S. ; Testani, Jeffrey M ; Leiter, Lawrence A. ; Bhatt, Deepak L ; Leiter, Lawrence A ; Bhatt, Ankeet S ; 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).

01 Sep 2024·NEUROBIOLOGY OF DISEASE

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

Article

Author: 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.

01 Sep 2024·JACC-Heart Failure

Cost-Effectiveness of Sotagliflozin in SOLOIST-WHF

Article

Author: Alva, Maria ; Weintraub, William S ; Bhatt, Deepak L ; Kolm, Paul ; Dolman, Sarahfaye ; Zhang, Zugui

BACKGROUND:

The efficacy of sotagliflozin in patients with diabetes and recent worsening of heart failure was shown in the SOLOIST-WHF trial. However, the cost-effectiveness of sotagliflozin in these patients has not been previously investigated.

OBJECTIVES:

The authors sought to determine the cost-effectiveness of sotagliflozin in patients with diabetes and recent worsening of heart failure.

METHODS:

Based on SOLOIST-WHF trial data (N = 1,222), the authors constructed a Markov model to estimate the lifetime impact of sotagliflozin from a U.S. health care sector perspective. Cost data were sourced from the National Inpatient Sample. Life expectancy was modeled from census data and modified by the mortality rate in SOLOIST-WHF. Fatal and nonfatal event rates were carried forward from the trial data. Utility was assessed from the published reports.

RESULTS:

Lifetime quality-adjusted life-years (QALYs) were 4.43 and 4.04 in the sotagliflozin and placebo groups, respectively, and lifetime costs were $220,113 and $188,198 in the sotagliflozin and placebo groups, respectively. The point estimate incremental cost-effectiveness ratio was $81,823 per QALY gained. The probability of being cost-effective was 3.6%, 67.5%, and 89.4% at willingness-to-pay thresholds of $50,000, $100,000, and $150,000, respectively, per QALY gained.

CONCLUSIONS:

In patients with diabetes and recent worsening of heart failure, sotagliflozin is cost-effective in the U.S. using commonly accepted willingness-to-pay thresholds. (Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure [SOLOIST-WHF]; NCT03521934).

134

News (Medical) associated with Sotagliflozin

01 Nov 2024

·www.biospace.com

Lexicon Loses FDA Adcomm Vote on Insulin Adjunct for Patients With Type 1 Diabetes

Pictured: Exterior view of the headquarters of the iStock, Grandbrothers While an FDA advisory committee saw signals of efficacy for Lexicon Pharmaceuticals’ sotagliflozin, the panel of external experts found that the company did not provide enough data to support its drug application. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Thursday voted against Lexicon Pharmaceuticals’ investigational type 1 diabetes therapy sotagliflozin. In an 11–3 vote, the panel of external experts found that sotagliflozin’s benefits do not outweigh its risks and that Lexicon has not provided enough clinical data to back the drug candidate. Lexicon is proposing sotagliflozin as an adjunct to insulin to help control blood glucose levels in patients with type 1 diabetes and chronic kidney disease. CEO Mike Exton in a statement said that Lexicon is “disappointed” by the outcome of the advisory committee vote, adding “we were encouraged by the rich discussion and outpouring of support across the diabetes community.” Thursday’s advisory committee meeting demonstrated the “urgent” need for an “FDA-approved treatment and clear education on managing risk,” Exton said. Sotagliflozin is a dual inhibitor of the SGLT2 and SGLT1 proteins, both of which function in the absorption of glucose in the kidney and gastrointestinal tract. Lexicon backed sotagliflozin’s application with three pivotal Phase III studies, which showed “consistent improvements in glycemic control and body weight,” according to Exton’s briefing document , published ahead of the adcomm meeting. Panelists on Thursday, however, were not convinced. “I actually didn’t see any data that demonstrated that the benefits outweighed the risk for this indication,” Cecilia Low Wang, professor of medicine at the University of Colorado, said during the meeting. “The numbers were incredibly small. I really feel like we need a prospective trial.” “I very much want an adjunctive drug for my patients with type 1 [diabetes]. I just don’t feel that it would fulfill my obligation to vote to approve something with so little supportive data. I feel like it does my patients a disservice,” Low Wang said. The external experts wanted to see more data in patients with eGFR values from 60 to less than 90, indicating relatively mild kidney damage or earlier-stage disease, for whom sotagliflozin appears to be more beneficial. “I felt that there was an uncertainty about the benefit-risk,” Connie Newman, adjunct professor in the Department of Medicine at the New York University School of Medicine, said during the meeting. “The group with GFR from 60 and 90 might be a population that will have a greater benefit than risk … and I would prefer to see more data in that population before I can make a decision about benefit-risk.” Thursday’s adcomm loss comes after a previous regulatory stumble in 2019, when the FDA hit the drug with a Complete Response Letter. Months before the rejection, the Endocrinologic and Metabolic Drugs Advisory Committee was split 50-50 on sotagliflozin, with many panelists expressing skepticism regarding the risk-benefit pro the drug. The FDA is currently reviewing Lexicon’s application for sotagliflozin and is set to release its decision on Dec. 20. The adcomm’s vote is non-binding and the FDA is not required to follow its recommendations, though the regulator often does.

Phase 3

01 Nov 2024

·www.pharmaceutical-technology.com

Lexicon stock tumbles after FDA AdCom votes against Zynquista again

Lexicon’s Zynquista is an oral dual inhibitor of the sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2), which play a role in glucose uptake and reabsorption. Image credit: eamesBot / Shutterstock. The US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (AdCom) has again voted against the approval of Lexicon Pharmaceutical’s Zynquista (sotagliflozin). The AdCom voted 3-11 against Zynquista as an add-on treatment to insulin therapy for managing blood glucose levels in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The committee noted that the therapy’s benefits do not outweigh its risks. Following the latest AdCom vote, Lexicon’s stock was down by 38.7% at market open today (1 November), compared to market close on 30 October, as trading was suspended yesterday (31 October) on account of the AdCom vote. The FDA had previously convened an AdCom to evaluate Zynquista’s efficacy in 2019. The panel voted 8-8 to decide whether the drug’s overall benefits outweighed the associated risks. The FDA ultimately declined to approve Zynquista at that time. The company provided additional data of the matched type 2 diabetes (T2D)-CKD population from the SCORED trial (NCT03315143) in the most recent AdCom, along with post hoc subgroup analysis from the three Tandem studies. Zynquista is an oral dual inhibitor of the sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2), which play a role in glucose uptake and reabsorption. In 2019, the European Medicines Agency (EMA) approved the therapy as an adjunct treatment to insulin in T1D and CKD. The therapy is also approved by the FDA to reduce the risk of cardiovascular death and heart failure in patients with either heart failure or T2D, CKD and other cardiovascular risk factors. It is marketed as Inpefa for the cardiovascular indication. Lexicon is seeking approval for Zynquista in patients with T1D and CKD who had an estimated glomerular filtration rate (eGFR) of 45 to less than 60 or an eGFR of greater than 60 with a urine albumin-to-creatinine ratio (uACR) of 30 or greater. While the FDA AdCom was not convinced of Zynquista’s efficacy in this population, some members did note that therapy’s benefit outweighed its risks in a subpopulation of patients who had an eGFR of 60 to less than 90 and those who have mild to moderate kidney disease. However, experts wanted more data to establish Zynquista’s efficacy in the subpopulation. An AdCom is convened upon request of the FDA to review and evaluate the safety and efficacy data of a particular therapy. However, the AdCom recommendations are non-binding, with the final decision ultimately made by the FDA.

Drug Approval

01 Nov 2024

·www.echemi.com

11 to 3! FDA Advisory Committee Again Rejects Lexicon Pharmaceuticals' New Drug, Shattering Hopes for Type 1 Diabetes Patients!

The independent advisory committee of the U.S. Food and Drug Administration (FDA) voted on Thursday to deny a recommendation for Lexicon Pharmaceuticals' drug for additional treatment beyond insulin therapy to control blood glucose levels in adults with Type 1 diabetes and chronic kidney disease. The committee's decision signifies a fresh setback in the company's long-standing efforts to gain a foothold in the market. In the day's vote, the experts rejected the benefits of sotagliflozin over its potential risks by a margin of 11 to 3. As early as the beginning of 2019, the FDA's advisory committee was divided on whether to recommend approval for a drug named sotagliflozin for the treatment of Type 1 diabetes. Soon after, the FDA did not approve the drug for market. Lexicon Pharmaceuticals resubmitted the drug for market approval in June 2024. The company is seeking approval for the drug for patients with Type 1 diabetes and chronic kidney disease whose kidney function scores or eGFR are in the ranges of 45 to less than 60, 60 to less than 90, and greater than 90. However, some committee members suggested that the benefits of the drug might outweigh the risks for specific patient groups with a kidney function score of less than 60 to 90 or those with mild to moderate kidney disease. But committee members expressed disappointment due to a lack of sufficient clinical data, stating that no prospective studies had been conducted on the patient subgroups that could potentially benefit the most. "I voted against it, but I wished I could have voted for it. I didn't vote for it because the nature of the issue is very special, and the population involved is extremely special... If the issue involved people aged 60 to 90, my position might have been different," said Cecilia Wang, who voted against it, expressing skepticism about the data for people aged 60 to less than 90. "The numbers are very limited. With the scarcity of relevant data, it's really hard for me to vote in favor of approving a new drug," she added.

Drug Approval

100 Deals associated with Sotagliflozin

External Link

KEGG	Wiki	ATC	Drug Bank
D10669	Sotagliflozin	A10BK06	DB12713

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Failure	US	Lexicon Pharmaceuticals, Inc.	26 May 2023
Diabetes Mellitus, Type 1	EU	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	IS	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	LI	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	NO	NCI Healthcare LLC	26 Apr 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	NDA/BLA	US	Lexicon Pharmaceuticals, Inc.	21 Jun 2024
Diabetic Nephropathies	Phase 3	US	Lexicon Pharmaceuticals, Inc.	15 Oct 2024
Diabetic Nephropathies	Phase 3	CA	Lexicon Pharmaceuticals, Inc.	15 Oct 2024
Kidney Failure, Chronic	Phase 3	US	Lexicon Pharmaceuticals, Inc.	15 Oct 2024
Kidney Failure, Chronic	Phase 3	CA	Lexicon Pharmaceuticals, Inc.	15 Oct 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	US	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic obstructive cardiomyopathy	Phase 3	US	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Diabetes Mellitus, Type 2	Phase 3	US	Sanofi	01 Nov 2016
Diabetes Mellitus, Type 2	Phase 3	US	Lexicon Pharmaceuticals, Inc.	01 Nov 2016
Diabetes Mellitus, Type 2	Phase 3	CA	Sanofi	01 Nov 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03285594 (SOTA-INS, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Sotagliflozin 400 mg	qsqfhpwvtp(unfukaddof) = cirwrvbgav qqaeoswene (mgsaquzara )	Positive	10 Sep 2024
				Sotagliflozin 200 mg	qsqfhpwvtp(unfukaddof) = jqvcehhozp qqaeoswene (mgsaquzara )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	Phase 3	Diabetes Mellitus, Type 2 \| Heart Failure	-	Sotagliflozin	btrvcnpvmg(iwjqgtczgz) = 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 aozlbjrqvo (hpvwcxtunx )	Positive	01 Sep 2024
				Placebo
SCORED (GlobeNewswire) Manual	Phase 3	Heart Failure	1,932	INPEFA® (sotagliflozin)	fmcsalbbss(ulrngslscw) = xdrgajpkqm afedeqspgh (ynakqzuqen )	Positive	14 May 2024
NCT03315143 (SCORED, ACC2024) Manual	Phase 3	Cardiovascular Diseases \| Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	10,584	Sotagliflozin	qyegwfsvgs(ukehzjxfjp) = foseorjnwy roaozuepzl (pxezbckclk ) View more	Positive	25 Mar 2024
				Placebo	qyegwfsvgs(ukehzjxfjp) = vidbwntdve roaozuepzl (pxezbckclk ) View more
SCORED (GlobeNewswire) Manual	Not Applicable	Heart Failure	-	INPEFA	usflwvinux(mfecpxkipn) = knnqdyyjqg bgxdytfquc (ysqzsjwxdc ) View more	Positive	12 Nov 2023
				placebo	-
NCT02531035 (inTandem 3, EASD2023)	Phase 3	Diabetes Mellitus, Type 1 BHB \| A1C \| UGE ... View more	1,402	Sotagliflozin 400 mg/d	jfiwvgewhh(fffdmizflb) = qrblmpslli swhvrbvemk (xzytrznsek ) View more	Positive	03 Oct 2023
				Placebo	jfiwvgewhh(fffdmizflb) = efgrnnggks swhvrbvemk (xzytrznsek )
NCT03521934 (SOLOIST, FDA) Manual	Phase 3	Heart Failure	1,222	INPEFA	otfsxnadec(mxtwhwzhsg) = tlrdovzrcz jboggcowde (cpsfnfwzbs ) View more	Positive	26 May 2023
				Placebo	otfsxnadec(mxtwhwzhsg) = sbiazwxzll jboggcowde (cpsfnfwzbs ) View more
NCT03315143 (SCORED, FDA) Manual	Phase 3	Heart Failure	10,584	INPEFA	uqcspriiwm(vkfhwvnnvd) = fmzpvbxnze wlopnxqiak (vlzfwzhbnh ) View more	Positive	26 May 2023
				Placebo	uqcspriiwm(vkfhwvnnvd) = tlvfbolhan wlopnxqiak (vlzfwzhbnh ) View more
SOLOIST-WHF (ESC2023)	Phase 3	Heart Failure	1,222	Sotagliflozin	blncebaqbm(mhzlrsiezj) = tnzrwofnpa ipqbtskoym (ujpykakxxy ) View more	-	20 May 2023
				Placebo	blncebaqbm(mhzlrsiezj) = kawbpdjrrg ipqbtskoym (ujpykakxxy ) View more
NCT03242252 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	787	Sotagliflozin 200 mg	lhfnegoiph(pljpuenibp) = pmijvjtxpz bbsvcjifyy (xuveemyrrx, -0.2 to 0.05)	-	13 Feb 2023
				Sotagliflozin 400 mg	lhfnegoiph(pljpuenibp) = vnqrntijka bbsvcjifyy (xuveemyrrx, -0.4 to -0.09)

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