NCT07228195 SGLT2i Therapy in Islet Transplantation (SIT)
| NCT ID | NCT07228195 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Minnesota |
| Condition | Partial Islet Function |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-07-21 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2026-07-21 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 18-70 years old; * \>1 year after TPIAT date at enrollment; * Partial islet function defined as stimulated C-peptide ≥0.6 ng/mL at screening/baseline visit, AND either (1) on insulin at ≤0.25 unit/kg/day OR (2) not on insulin but HbA1c \>6.5%; * Stable diabetes management defined by stable on pump or multiple daily injections (MDI) for at least 8 weeks and \<25% change in insulin dosing over prior 8 weeks. * Willing to manage diabetes medication management/dose adjustments for the duration of the study with study team MD * Willing to wear continuous glucose monitor for diabetes management (currently standard of care for TPIAT diabetes) * Willing to record insulin doses for 14 day intervals x 3 study visits. * Willing and able to come to the UMN Clinical Research Unit for 3 study visits, approximately 3 months apart * No prescribed medications other than insulin to treat diabetes in the past 4 weeks. Exclusion Criteria: * HbA1c \>9%; on any non-insulin antihyperglycemic medication; * History of diabetic ketoacidosis (DKA) in the past 1 year; * Unable to drink Boost HP due to true milk protein allergy; * Underweight (BMI \<18.5 kg/m2) \[contraindicated by possible weight loss with SGLT2 inhibitors\]; * Renal failure defined by glomerular filtration rate \<30 mL/min/m2; * Recurrent dehydration necessitating ED/hospital visits; one time/ rare hospital visits due to intercurrent illness are not exclusionary but repeated dehydration from a chronic condition will be exclusionary. * Expected to need systemic corticosteroids at \>25 mg/day hydrocortisone equivalent over the 6-month study interval; * Known allergy to empagliflozin; * Currently pregnant or plan to become pregnant in the next 6 months (for females), or currently breastfeeding; * Unwillingness to consent or return for study visits; * Non-English speaking. * Any other medical contraindication to treatment or study participation in the opinion of the investigator that would impact either patient's safety or their ability to complete the study.
Contact & Investigator
Melena Bellin, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT07228195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Partial Islet Function. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07228195 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07228195 currently recruiting?
Yes, NCT07228195 is actively recruiting participants. Contact the research team at vorwa001@umn.edu for enrollment information.
Where is the NCT07228195 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07228195 clinical trial?
NCT07228195 is sponsored by University of Minnesota. The principal investigator is Melena Bellin, MD at University of Minnesota. The trial plans to enroll 40 participants.