SGLT2i Therapy in Islet Transplantation (SIT)
Part of paid clinical trials in Minneapolis, Minnesota.
- Sponsor
- University of Minnesota
- Study ID
- NCT07228195
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Diabetes
- Partial Islet Function
- TPIAT
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empagliflozin 25 MG Oral Tablet — DRUGEmpagliflozin, which is sold under the name of Jardiance, is FDA approved for patients 10 years of age and older to improve glycemic control in type 2 diabetes.
- Empagliflozin 10 MG Oral Tablet [Jardiance] — DRUGEmpagliflozin, which is sold under the name of Jardiance, is FDA approved for patients 10 years of age and older to improve glycemic control in type 2 diabetes.
Study Details
This pilot clinical trial is designed to gather preliminary data on the efficacy and safety of empagliflozin, a diabetes drug in the sodium-glucose cotransporter 2 inhibitor (SGLT2i) class, in islet autotransplant recipients who have partial islet function.
Key Dates
- Start date
- Jul 15, 2026
- Status verified
- May 2026
- Primary completion
- Dec 1, 2028
- Completion
- Dec 1, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: No Medication x 3 months, then 25 mg Empagliflozin x 3 months
- Active Comparator: Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months
- Active Comparator: Empagliflozin 25 mg x 6 months
Primary Outcome Measure
Time In Range (TIR) 70- 180 mg/dL [ Time Frame: Month 3 ]
Central Contacts
- Peggy Ptacek612-626-5905
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | Peggy Ptacek |
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