SGLT2i Therapy in Islet Transplantation (SIT)

NCT ID: NCT07228195

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2028-12-01

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.

Conditions

Partial Islet Function; TPIAT; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Medication x 3 months, then 25 mg Empagliflozin x 3 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months

Group Type: ACTIVE_COMPARATOR

Empagliflozin 10 MG Oral Tablet [Jardiance]

Intervention Type: 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 25 mg x 6 months

Group Type: ACTIVE_COMPARATOR

Empagliflozin 25 MG Oral Tablet

Intervention Type: 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.

Interventions

Empagliflozin 25 MG Oral Tablet

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.

Intervention Type: DRUG

Empagliflozin 10 MG Oral Tablet [Jardiance]

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melena Bellin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Central Contacts

Peggy Ptacek

Role: CONTACT

vorwa001@umn.edu

612-626-5905

Facility Contacts

Peggy Ptacek

Role: primary

vorwa001@umn.edu

Other Identifiers

PEDS-2025-34226

Identifier Type: -

Identifier Source: org_study_id