Empagliflozin for Partial Islet Function Post-Transplant
SGLT2i Therapy in Islet Transplantation (SIT)
Recruiting
Phase 4Interventional Study
Partial Islet FunctionTPIATDiabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 70 who have had islet transplants over a year ago and have partial islet function. Participants will take a diabetes medication and help manage their insulin and glucose levels with support from the study team.
Are You a Good Fit for This Trial?
Must be takingInsulin
You may be able to join if
I am between 18 and 70 years old.
I had a partial islet transplant more than 1 year ago.
I have partial islet function defined as a C-peptide level of at least 0.6 ng/mL.
I manage my diabetes with a stable insulin pump or injections for the last 8 weeks.
I can wear a continuous glucose monitor.
I can record my insulin doses for 14 days for three study visits.
I can attend three study visits at the UMN Clinical Research Unit.
You may not be able to join if
My HbA1c level is over 9%.
I have had diabetic ketoacidosis in the last year.
I am currently pregnant or plan to become pregnant in the next 6 months.
I have a true milk protein allergy.
I weigh less than 18.5 BMI.
I have kidney failure.
I frequently need hospital visits for dehydration.
I am allergic to empagliflozin.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 …
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.
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