SGLT2i Therapy in Islet Transplantation (SIT)

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07228195
Phase
PHASE4
Status
Recruiting
Apply to this trial

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 — DRUG
    Empagliflozin, 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] — DRUG
    Empagliflozin, 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

First listed
Nov 14, 2025
Start date
Jul 21, 2026
Status verified
Jul 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Peggy Ptacek
[email protected]

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By research site
University of Minnesota· Minneapolis, MN

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