Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT07211802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CKM For Safe Use of SGLT2i in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575681', 'term': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2025-06-16', 'studyFirstSubmitQcDate': '2025-10-07', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BHB Time Above 0.6mmol/L - 200mg', 'timeFrame': '6 weeks', 'description': 'Beta hydroxybutyrate (BHB) time \\> 0.6 millimole per liter (mmol/L) as measured by the DGK during the 200mg dosing period in the MDI vs. HCL groups.'}, {'measure': 'BHB Time Above 0.6mmol/L - 400mg', 'timeFrame': '6 weeks', 'description': 'Beta hydroxybutyrate (BHB) time \\> 0.6 mmol/L as measured by the DGK during the 400mg dosing period in the MDI vs. HCL groups.'}], 'secondaryOutcomes': [{'measure': 'BHB Time Above 0.6mmol/L - 200mg vs. 400mg', 'timeFrame': '6 weeks', 'description': 'Beta hydroxybutyrate (BHB) time \\> 0.6 mmol/L as measured by the DGK comparing the 200mg treatment period to the 400mg treatment period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Sotagliflozin', 'SGLT2', 'Continuous Ketone Monitor', 'DGK', 'CKM'], 'conditions': ['Type 1 Diabetes (T1D)']}, 'descriptionModule': {'briefSummary': 'This research study is being conducted to learn if wearing a combination continuous glucose monitor/continuous ketone monitor (CGM/CKM) can reduce the side effects of taking sotagliflozin (study drug) in people with type 1 diabetes.', 'detailedDescription': 'The study is a phase 3, single-site, double-blind, random-order, cross-over study to evaluate the use of continuous ketone monitoring (CKM) in participants with type 1 diabetes taking sotagliflozin.\n\nThere will be 2 main groups in the study, participants on Hybrid Closed Loop insulin pumps (HCL), n=26, and participants on Multiple Daily Injections (MDI), n=26. There will also be 2 doses of sotagliflozin examined in the study, 200 milligram (mg) once daily and 400mg once daily. Therefore, there will be 4 treatment groups in the study:\n\n* MDI participants who receive 200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks;\n* MDI participants who receive 400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks;\n* HCL participants who receive 200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks;\n* HCL participants who receive 400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks.\n\nIn addition, there will be an open-label extension study for the HCL group. In the extension study, the 26 participants in the HCL group will remain on their insulin pump, receive a low-dose, open-label, once daily injection of long-acting insulin and complete an additional 6 weeks of dosing with open-label 400 mg sotagliflozin.\n\nFor MDI participants there will be a total of 12 visits over approximately 22 weeks. For HCL participants there will be a total of 16 visits over approximately 28 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All individuals between the ages of \\>18 years old, inclusive, at the time of screening;\n2. Individuals able to become pregnant must:\n\n 1. be ≥1 year post-menopausal or documented as being surgically sterile, or\n 2. agree to use two methods of contraception during the entire study and for an additional 2 weeks after the end of dosing with the investigational product;\n3. Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study and for an additional 2 weeks after the end of the treatment period;\n4. Diagnosed with Type 1 diabetes ≥ 1 year prior to screening, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;\n5. Treatment with a stable insulin regimen for at least 8 weeks before screening with:\n\n 1. a continuous subcutaneous insulin infusion (CSII) via a hybrid closed loop system, or\n 2. multiple daily insulin injections;\n6. Currently using a Continuous Glucose Monitoring (CGM) system;\n7. Hemoglobin A1c ≤10% at the time of screening;\n8. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2;\n9. Agrees and is able to wear the investigational device;\n10. Able to provide written informed consent approved by an Institutional Review Board (IRB).\n\nExclusion Criteria:\n\n1. Individuals who are currently pregnant or lactating/breastfeeding, or planning to become pregnant within 10 months after screening;\n2. Any concurrent diagnosis of diabetes other than type 1 diabetes;\n3. History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;\n4. Hypotension at screening as defined as, systolic blood pressure \\< 90 and diastolic blood pressure \\< 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations);\n5. Current or recent (within 1 month prior to screening) use of diabetes medications other than insulin; (examples include, Sodium-Glucose Cotransporter 2 (SGLT-2i), Pramlintide, Metformin);\n6. Use of glucagon-like-peptide 1 (GLP-1) analogues if not on a stable dose for \\> 2 months at screening (participants can be rescreened after being on stable dose for \\> 2 months). Participants on a stable dose of GLP-1 receptor antagonist (RA) and not experiencing frequent vomiting may be included.\n7. Chronic systemic corticosteroids use ( \\> 4 consecutive weeks) within 6 months prior to screening;\n8. History of diabetic ketoacidosis within 3 months prior screening;\n9. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.\n\n * ADA Level 3 Definition - A severe hypoglycemic event characterized by altered mental or physical status requiring the assistance for treatment of hypoglycemia, irrespective of glucose level;\n10. History of multiple (≥3 infections) genital mycotic infections within 6 months of screening;\n11. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;\n12. Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.'}, 'identificationModule': {'nctId': 'NCT07211802', 'briefTitle': 'CKM For Safe Use of SGLT2i in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Utilizing Continuous Ketone Monitors to Enable Safe Use of SGLT Inhibitors in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '812125'}, 'secondaryIdInfos': [{'id': '1R01DK143381', 'type': 'OTHER_GRANT', 'domain': 'NIH'}, {'id': '1U01DK143381', 'link': 'https://reporter.nih.gov/quickSearch/1U01DK143381', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group A', 'description': '200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks', 'interventionNames': ['Drug: Sotagliflozin Low Dose', 'Drug: Sotagliflozin High Dose', 'Device: Dual Continuous Glucose and Ketone Monitor']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group B', 'description': '400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks', 'interventionNames': ['Drug: Sotagliflozin Low Dose', 'Drug: Sotagliflozin High Dose', 'Device: Dual Continuous Glucose and Ketone Monitor']}], 'interventions': [{'name': 'Sotagliflozin Low Dose', 'type': 'DRUG', 'description': '200 mg Sotagliflozin, once daily for 6 weeks', 'armGroupLabels': ['Treatment Group A', 'Treatment Group B']}, {'name': 'Sotagliflozin High Dose', 'type': 'DRUG', 'description': '400 mg Sotagliflozin, once daily for 6 weeks', 'armGroupLabels': ['Treatment Group A', 'Treatment Group B']}, {'name': 'Dual Continuous Glucose and Ketone Monitor', 'type': 'DEVICE', 'description': 'Abbott Libre X dual continuous glucose and ketone monitor (DGK) device.', 'armGroupLabels': ['Treatment Group A', 'Treatment Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Recruiter', 'role': 'CONTACT', 'email': 't1dresearch@health.ucsd.edu', 'phone': '858-246-2146'}, {'name': 'Jeremy Pettus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSD - Altman Clinical & Translational Research Institute', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Program Manager, MS', 'role': 'CONTACT', 'email': 't1dresearch@health.ucsd.edu', 'phone': '858-246-2169'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Abbott', 'class': 'INDUSTRY'}, {'name': 'Lexicon Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jeremy Pettus, MD', 'investigatorAffiliation': 'University of California, San Diego'}}}}