Status:
RECRUITING
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Lexicon Pharmaceuticals
Conditions:
Platelet Function and Reactivity Tests
Eligibility:
All Genders
18-79 years
Phase:
EARLY_PHASE1
Brief Summary
This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.
Eligibility Criteria
Inclusion
- \-
Exclusion
- Students under the direct supervision of Dr. Michael Holinstat
- Subjects diagnosed with Type I diabetes or those with ketoacidosis
- Subjects with a history of alcohol abuse, pancreatitis or pancreatic surgery, or subjects taking a ketogenic diet
- Women who self-identify as being pregnant or who are planning to become pregnant during the 14 week study will be excluded from the study, as are those who are breastfeeding (women enrolled in the study will be given a urine pregnancy test at the start of each drug administration period to confirm pregnancy status)
- Subjects with hypersensitivity to aspirin, clopidogrel, apixaban, or sotagliflozin are excluded
- have active bleeding, or who have who have a history of balanitis or balanoposthitis, genital mycotic infections, or a planned elective surgical/dental procedure 1 month prior to or following completion of study
- Subjects who have taken Non-Steroidal Anti-Inflammatory Drugs (NSAIDS; examples of NSAIDS are Ibuprofen (Advil, Motrin) and Naproxen (Aleve)) or aspirin within 7 days prior to the study or anticoagulants within 10 days prior to the study
- individuals currently taking SSRI's (for example, Fluoxetine (Prozac), Sertraline (Zoloft), Paroxetine (Paxil), Citalopram (Celexa), and Escitalopram (Lexapro).), SNRI's (Duloxetine (Cymbalta), Venlafaxine (Effexor XR), Desvenlafaxine (Pristiq), and Levomilnacipran (Fetzima)), lithium, or omeprazole/esomeprazole
- Subjects less than or equal to 60 kg will be excluded
- Subjects with a creatinine greater than or equal to 1.5 mg/dl will be excluded
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06933056
Start Date
September 2 2025
End Date
September 1 2026
Last Update
September 15 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109