Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-01 @ 4:15 PM
Study NCT ID:
NCT07228195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SGLT2i Therapy in Islet Transplantation (SIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, open label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-10-17', 'studyFirstSubmitQcDate': '2025-11-12', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time In Range (TIR) 70- 180 mg/dL', 'timeFrame': 'Month 3', 'description': 'the primary comparison is between three treatment arms (control, empagliflozin 10 mg, and empagliflozin 25 mg) at 3 months on treatment'}], 'secondaryOutcomes': [{'measure': 'Time in Tight Range (TITR) 70-140 mg/dL', 'timeFrame': 'Month 3', 'description': 'from 14 days of home monitoring'}, {'measure': 'Time in Tight Range (TITR) 70-140 mg/dL', 'timeFrame': 'Month 6', 'description': 'from 14 days of home monitoring'}, {'measure': 'Time in hypoglycemia <70 mg/dL', 'timeFrame': 'Month 3', 'description': 'from 14 days of home monitoring'}, {'measure': 'Time in hypoglycemia <70 mg/dL', 'timeFrame': 'Month 6', 'description': 'from 14 days of home monitoring'}, {'measure': 'Time in hypoglycemia <54 mg/dL', 'timeFrame': 'Month 3', 'description': 'from 14 days of home monitoring'}, {'measure': 'Time in hypoglycemia <54 mg/dL', 'timeFrame': 'Month 6', 'description': 'from 14 days of home monitoring'}, {'measure': 'Time in hyperglycemia >180 mg/dL', 'timeFrame': 'Month 3', 'description': 'from 14 days of home monitoring'}, {'measure': 'Time in hyperglycemia >180 mg/dL', 'timeFrame': 'Month 6', 'description': 'from 14 days of home monitoring'}, {'measure': 'Area under the curve 2 hour glucose from MMTT', 'timeFrame': 'Month 3'}, {'measure': 'Area under the curve 2 hour glucose from MMTT', 'timeFrame': 'Month 6'}, {'measure': 'Hemoglobin A1c level', 'timeFrame': 'Month 3'}, {'measure': 'Hemoglobin A1c level', 'timeFrame': 'Month 6'}, {'measure': 'Proinsulin', 'timeFrame': 'Month 3', 'description': 'C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker)'}, {'measure': 'Proinsulin', 'timeFrame': 'Month 6', 'description': 'C-peptide ratios during MMTT at fasting and +90 minutes (beta-cell ER stress marker)'}, {'measure': 'Proportion of patients with ketones >=1.5', 'timeFrame': 'Month 3', 'description': 'Routine home serum ketone testing'}, {'measure': 'Proportion of patients with ketones >=1.5', 'timeFrame': 'Month 6', 'description': 'Routine home serum ketone testing'}, {'measure': 'ED/ hospital visits for diabetic ketoacidosis (DKA)', 'timeFrame': 'Month 3', 'description': 'number of visits'}, {'measure': 'ED/ hospital visits for diabetic ketoacidosis (DKA)', 'timeFrame': 'Month 6', 'description': 'number of visits'}, {'measure': 'Occurrence of urinary or genital tract infection', 'timeFrame': 'Month 3'}, {'measure': 'Occurrence of urinary or genital tract infection', 'timeFrame': 'Month 6'}, {'measure': 'Weight change', 'timeFrame': 'Month 3', 'description': '% weight loss or weight gain'}, {'measure': 'Weight change', 'timeFrame': 'Month 6', 'description': '% weight loss or weight gain'}, {'measure': 'Diabetes distress', 'timeFrame': 'Month 3', 'description': 'Diabetes Distress Score; Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem."'}, {'measure': 'Diabetes distress', 'timeFrame': 'Month 6', 'description': 'Diabetes Distress Score; Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Partial Islet Function', 'TPIAT', 'Diabetes']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-70 years old;\n* \\>1 year after TPIAT date at enrollment;\n* 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%;\n* 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.\n* Willing to manage diabetes medication management/dose adjustments for the duration of the study with study team MD\n* Willing to wear continuous glucose monitor for diabetes management (currently standard of care for TPIAT diabetes)\n* Willing to record insulin doses for 14 day intervals x 3 study visits.\n* Willing and able to come to the UMN Clinical Research Unit for 3 study visits, approximately 3 months apart\n* No prescribed medications other than insulin to treat diabetes in the past 4 weeks.\n\nExclusion Criteria:\n\n* HbA1c \\>9%; on any non-insulin antihyperglycemic medication;\n* History of diabetic ketoacidosis (DKA) in the past 1 year;\n* Unable to drink Boost HP due to true milk protein allergy;\n* Underweight (BMI \\<18.5 kg/m2) \\[contraindicated by possible weight loss with SGLT2 inhibitors\\];\n* Renal failure defined by glomerular filtration rate \\<30 mL/min/m2;\n* 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.\n* Expected to need systemic corticosteroids at \\>25 mg/day hydrocortisone equivalent over the 6-month study interval;\n* Known allergy to empagliflozin;\n* Currently pregnant or plan to become pregnant in the next 6 months (for females), or currently breastfeeding;\n* Unwillingness to consent or return for study visits;\n* Non-English speaking.\n* 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."}, 'identificationModule': {'nctId': 'NCT07228195', 'briefTitle': 'SGLT2i Therapy in Islet Transplantation (SIT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'SGLT2i Therapy in Islet Transplantation (SIT)', 'orgStudyIdInfo': {'id': 'PEDS-2025-34226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Medication x 3 months, then 25 mg Empagliflozin x 3 months'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months', 'interventionNames': ['Drug: Empagliflozin 10 MG Oral Tablet [Jardiance]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Empagliflozin 25 mg x 6 months', 'interventionNames': ['Drug: Empagliflozin 25 MG Oral Tablet']}], 'interventions': [{'name': 'Empagliflozin 25 MG Oral Tablet', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Empagliflozin 25 mg x 6 months']}, {'name': 'Empagliflozin 10 MG Oral Tablet [Jardiance]', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Empagliflozin 10 mg x 3 months, then 25 mg Empagliflozin x 3 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Peggy Ptacek', 'role': 'CONTACT', 'email': 'vorwa001@umn.edu'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Peggy Ptacek', 'role': 'CONTACT', 'email': 'vorwa001@umn.edu', 'phone': '612-626-5905'}], 'overallOfficials': [{'name': 'Melena Bellin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}