Sotagliflozin vs. Empagliflozin for Blood Clots

(SOTATHROMBUS Trial)

Overseen By Mohammad U Zafar

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: All medications

Disqualifiers: Cardiovascular, Pulmonary, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two medications, sotagliflozin and empagliflozin, to determine which is safer and more effective at preventing blood clots in healthy individuals. Researchers aim to discover if sotagliflozin, which targets two receptors instead of one, can better reduce clotting risk compared to empagliflozin. Healthy adults with no ongoing medical conditions who can provide consent are suitable for this study. Participants will take each medication for a month, with a break in between, and tests will measure each drug's effectiveness in stopping clot formation. As a Phase 4 trial, this research involves FDA-approved treatments and helps understand their benefits for more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications at least one month before starting the study, except for oral contraceptives or occasional use of acetaminophen or an antihistamine.

What is the safety track record for these treatments?

Previous studies have shown that sotagliflozin is well-tolerated. Patients taking it for heart failure reported fewer blood clots than those on a placebo, suggesting it might be safer for preventing clots. Sotagliflozin already has approval for certain heart conditions, which adds confidence in its safety.

Empagliflozin, another treatment in this study, belongs to a group of drugs called SGLT2 inhibitors. Research suggests it does not increase the risk of blood clots. However, some users may experience an increase in red blood cells, which requires monitoring. Overall, it has been used safely in many patients with diabetes and heart issues. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Sotagliflozin and Empagliflozin because they both work by blocking proteins called SGLT2 that are involved in glucose reabsorption in the kidneys, a mechanism that can potentially reduce the risk of blood clots. Unlike standard blood clot treatments that typically focus on anticoagulation, these drugs tackle the issue through metabolic pathways, which might offer additional benefits for managing blood sugar levels. Sotagliflozin is particularly interesting as it also inhibits SGLT1, which might provide unique advantages in reducing clot formation while also managing glucose levels more effectively. This dual action could make it a compelling alternative or complement to current therapies.

What evidence suggests that this trial's treatments could be effective for blood clots?

This trial will compare Sotagliflozin and Empagliflozin for their effects on blood clots. Studies have shown that sotagliflozin significantly lowers the risk of serious heart problems, such as heart attacks and strokes, in people with diabetes and heart failure. It also reduces the likelihood of death from heart issues and hospitalizations. Research suggests that sotagliflozin targets both SGLT1 and SGLT2, potentially offering extra benefits compared to treatments like empagliflozin, which focus only on SGLT2.

Empagliflozin supports heart and kidney health in individuals with heart failure and diabetes. It does not increase the risk of blood clots, a concern with some other treatments. Both treatments have strong evidence supporting their heart health benefits, but sotagliflozin might offer additional advantages due to its dual action. Participants in this trial will receive both treatments in different sequences to evaluate their effects. ^{2 3 5 6 7}

Who Is on the Research Team?

Juan J Badimon

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for healthy volunteers interested in contributing to research on heart failure treatments. Participants will be involved in a study comparing two drugs, Sotagliflozin and Empagliflozin, which may affect blood clotting differently.

Inclusion Criteria

Ability to provide signed informed consent

I am over 18 years old.

I am currently free from any signs of disease, as confirmed by my doctor.

Exclusion Criteria

Pregnant or lactating women

History of drug abuse or alcohol consumption exceeding 20 g/day

I have no significant ongoing health issues besides my current condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1-month of Sotagliflozin treatment followed by a 1-month washout period, then 1-month of Empagliflozin treatment

3 months

Visits at baseline, end of each treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empagliflozin
• Sotagliflozin

Trial Overview Researchers are testing whether Sotagliflozin, a dual inhibitor affecting glucose transporters, can better prevent blood clots compared to Empagliflozin in cardiovascular patients. The study uses a cross-over design where participants receive both drugs at different times.

How Is the Trial Designed?

Group I: Sotagliflozin then Empagliflozin Experimental Treatment 2 Interventions

Subjects randomized to 'Arm A' will receive 1-month of 'Sotagliflozin' treatment first and then 1-month of 'Empagliflozin' treatment second, separated by a 1-month of washout period.

Group II: Empagliflozin then Sotagliflozin Experimental Treatment 2 Interventions

Subjects randomized to 'Arm B' will receive1-month of 'Empagliflozin' treatment first and then1-month of 'Sotagliflozin' treatment second, separated by a 1-month of washout peri od

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Approved in United States as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease
• Cardiovascular risk reduction

Approved in Canada as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Approved in Japan as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9186250/

a systematic review and meta-analysis - PMC Efficacy of empagliflozin on heart failure and renal outcomes in patients with atrial fibrillation: data from the EMPA-REG OUTCOME trial.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835466

Sodium-Glucose Cotransporter 2 Inhibitors, Erythrocytosis ... Additional outcomes included the development of thrombotic events, including arterial (myocardial infarction and stroke) and venous (deep ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.068613

Comparative Cardiovascular Effectiveness of Empagliflozin ... Empagliflozin and dapagliflozin initiators had no differences in 6-year cardiovascular outcomes in adults with treated type 2 diabetes.

4. pharmacytimes.com pharmacytimes.com/view/understanding-the-link-between-sglt2-inhibitors-red-blood-cell-counts-and-blood-clots-in-adults-with-type-2-diabetes

Understanding the Link Between SGLT2 Inhibitors, Red ... No Evidence of Increase in Blood Clot Risk. The results are encouraging despite worries that erythrocytosis could result in thrombosis.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000293432031113X

Sodium-Glucose Co-Transporter 2 Inhibitors and the Risk ... Our large cohort study suggests that SGLT2 inhibitors are not associated with a higher rate of venous thromboembolism when compared with DPP-4 inhibitors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12431824/

Novel Antidiabetic Drugs and Risk of Venous Thromboembolism A total of six studies examined the association between DPP-4 inhibitors and VTE risk. Three of these studies used public health care data to detect drug safety ...

7. medsafe.govt.nz medsafe.govt.nz/profs/PUArticles/June2023/SGLT2-inhibitors-potential-risk-polycythaemia.html

Sodium-glucose co-transporter 2 (SGLT2) inhibitors and ... This article highlights information about the potential risk of polycythaemia with sodium-glucose co-transporter 2 (SGLT2) inhibitor medicines.