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Recruiting NCT07228195

SGLT2i Therapy in Islet Transplantation (SIT)

Phase IV Interventional Partial Islet Function TPIAT Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin 25 MG Oral Tablet, Empagliflozin 10 MG Oral Tablet [Jardiance].
Who it may be relevant to
Registry conditions: Partial Islet Function, TPIAT, Diabetes. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug 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.
  • 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.

Primary outcome measures

  • Time In Range (TIR) 70- 180 mg/dL [Time frame: Month 3]
Secondary outcome measures (12)
  • Time in Tight Range (TITR) 70-140 mg/dL [Time frame: Month 3]
  • Time in Tight Range (TITR) 70-140 mg/dL [Time frame: Month 6]
  • Time in hypoglycemia <70 mg/dL [Time frame: Month 3]
  • Time in hypoglycemia <70 mg/dL [Time frame: Month 6]
  • Time in hypoglycemia <54 mg/dL [Time frame: Month 3]
  • Time in hypoglycemia <54 mg/dL [Time frame: Month 6]
  • Time in hyperglycemia >180 mg/dL [Time frame: Month 3]
  • Time in hyperglycemia >180 mg/dL [Time frame: Month 6]
  • Area under the curve 2 hour glucose from MMTT [Time frame: Month 3]
  • Area under the curve 2 hour glucose from MMTT [Time frame: Month 6]
  • Hemoglobin A1c level [Time frame: Month 3]
  • Hemoglobin A1c level [Time frame: Month 6]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07228195 · PEDS-2025-34226

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗