SGLT2i Therapy in Islet Transplantation (SIT)

NCT07228195 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: PEDS-2025-34226
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

TPIAT; Partial Islet Function; Diabetes

Outcome Measures

Primary Outcomes (1)

• Time In Range (TIR) 70- 180 mg/dL

  the primary comparison is between three treatment arms (control, empagliflozin 10 mg, and empagliflozin 25 mg) at 3 months on treatment

  Month 3

Secondary Outcomes (24)

• Time in Tight Range (TITR) 70-140 mg/dL

  Month 3

• Time in Tight Range (TITR) 70-140 mg/dL

  Month 6

• Time in hypoglycemia <70 mg/dL

  Month 3

• Time in hypoglycemia <70 mg/dL

  Month 6

• Time in hypoglycemia <54 mg/dL

  Month 3

Study Arms (3)

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

NO INTERVENTION

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

ACTIVE COMPARATOR

Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]

Empagliflozin 25 mg x 6 months

ACTIVE COMPARATOR

Drug: Empagliflozin 25 MG Oral Tablet

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 25 mg x 6 months

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

empagliflozin; Tablets

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Melena Bellin, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peggy Ptacek

CONTACT

612-626-5905; vorwa001@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, open label

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: November 14, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)