NCT07228195 · University of Minnesota
SGLT2i Therapy in Islet Transplantation (SIT)
What this study is about
This pilot clinical trial is designed to gather preliminary data on the effectiveness 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.
View original scientific description
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
the primary comparison is between three treatment arms (control, empagliflozin 10 mg, and empagliflozin 25 mg) at 3 months on treatment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Minneapolis, Minnesota
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 22, 2026 · Source of record for eligibility and locations