Partial Islet FunctionPhase 4NCT07228195
SGLT2i Therapy in Islet Transplantation (SIT)
A Phase 4 study testing Empagliflozin 25 MG Oral Tablet and Empagliflozin 10 MG Oral Tablet [Jardiance] in people with Partial Islet Function and TPIAT, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Partial Islet Function, TPIAT, Diabetes
- What is being tested?
- Empagliflozin 25 MG Oral Tablet and Empagliflozin 10 MG Oral Tablet [Jardiance]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2026to 1 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Peggy Ptacek, vorwa001@umn.edu
About this study
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
- Being tested
- Empagliflozin 25 MG Oral Tablet, Empagliflozin 10 MG Oral Tablet [Jardiance]
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MG Oral TabletDrug
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 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.
| Study group | Role | What they receive |
|---|---|---|
| No Medication x 3 months, then 25 mg Empagliflozin x 3 months | No intervention | Not described |
| Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months | Active comparator | Not described Receives: Drug: Empagliflozin 10 MG Oral Tablet [Jardiance] |
| Empagliflozin 25 mg x 6 months | Active comparator | Not described Receives: Drug: Empagliflozin 25 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 3
Secondary outcomes (24)
Time in Tight Range (TITR) 70-140 mg/dL
from 14 days of home monitoring
Measured: Month 3
Time in Tight Range (TITR) 70-140 mg/dL
from 14 days of home monitoring
Measured: Month 6
Time in hypoglycemia <70 mg/dL
from 14 days of home monitoring
Measured: Month 3
Time in hypoglycemia <70 mg/dL
from 14 days of home monitoring
Measured: Month 6
Time in hypoglycemia <54 mg/dL
from 14 days of home monitoring
Measured: Month 3
Time in hypoglycemia <54 mg/dL
from 14 days of home monitoring
Measured: Month 6
Time in hyperglycemia >180 mg/dL
from 14 days of home monitoring
Measured: Month 3
Time in hyperglycemia >180 mg/dL
from 14 days of home monitoring
Measured: Month 6
Area under the curve 2 hour glucose from MMTT
Measured: Month 3
Area under the curve 2 hour glucose from MMTT
Measured: Month 6
Hemoglobin A1c level
Measured: Month 3
Hemoglobin A1c level
Measured: Month 6
Proinsulin
C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker)
Measured: Month 3
Proinsulin
C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker)
Measured: Month 6
Proportion of patients with ketones >=1.5
Routine home serum ketone testing
Measured: Month 3
Proportion of patients with ketones >=1.5
Routine home serum ketone testing
Measured: Month 6
ED/ hospital visits for diabetic ketoacidosis (DKA)
number of visits
Measured: Month 3
ED/ hospital visits for diabetic ketoacidosis (DKA)
number of visits
Measured: Month 6
Occurrence of urinary or genital tract infection
Measured: Month 3
Occurrence of urinary or genital tract infection
Measured: Month 6
Weight change
% weight loss or weight gain
Measured: Month 3
Weight change
% weight loss or weight gain
Measured: Month 6
Diabetes distress
Diabetes Distress Score; Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem."
Measured: Month 3
Diabetes distress
Diabetes Distress Score; Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem."
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start21 Jul 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Islet FunctionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, open label
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melena Bellin, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228195
- Sponsor's protocol ID
- PEDS-2025-34226
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2i Therapy in Islet Transplantation (SIT)
- ClinicalTrials.gov ID
- NCT07228195
- Acronym / sponsor ID
- PEDS-2025-34226
- Conditions
- Partial Islet Function, TPIAT, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized, open label
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 25 MG Oral TabletEmpagliflozin, 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 25 mg x 6 months |
| 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. | Drug | Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months |
Primary outcome
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
24 secondary outcomes
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
Proinsulin
Time frame: Month 3
Proinsulin
Time frame: Month 6
Proportion of patients with ketones >=1.5
Time frame: Month 3
Proportion of patients with ketones >=1.5
Time frame: Month 6
ED/ hospital visits for diabetic ketoacidosis (DKA)
Time frame: Month 3
ED/ hospital visits for diabetic ketoacidosis (DKA)
Time frame: Month 6
Occurrence of urinary or genital tract infection
Time frame: Month 3
Occurrence of urinary or genital tract infection
Time frame: Month 6
Weight change
Time frame: Month 3
Weight change
Time frame: Month 6
Diabetes distress
Time frame: Month 3
Diabetes distress
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melena Bellin, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin 25 MG Oral Tablet and Empagliflozin 10 MG Oral Tablet [Jardiance] in people with Partial Islet Function and TPIAT, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peggy Ptacek (612-626-5905, vorwa001@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time In Range (TIR) 70- 180 mg/dL (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.