Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT07186660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007662', 'term': 'Ketosis'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Clinical research team'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Brachial Artery Flow-Mediated Dilation', 'timeFrame': '12 weeks', 'description': 'Noninvasive measurement of blood vessel function'}, {'measure': 'Carotid-Femoral Pulse Wave Velocity', 'timeFrame': '12 weeks', 'description': 'Noninvasive measure of aortic stiffness'}, {'measure': 'Radial Artery Augmentation Index', 'timeFrame': '12 weeks', 'description': 'Noninvasive measure of radial artery stiffness'}, {'measure': 'C-peptide', 'timeFrame': '12 weeks', 'description': 'Blood test that measures endogenous insulin secretion'}, {'measure': 'Daily fasting ketone level', 'timeFrame': '12 weeks', 'description': 'Measure of blood ketone level collected by fingerstick meter conducted at home each morning'}, {'measure': 'Cardiovascular Biomarkers', 'timeFrame': '12 weeks', 'description': 'IL-6, TNF-alpha, hsCRP, E-selectin, ICAM-1, adiponectin'}, {'measure': 'Peripheral Blood Mononuclear Cells', 'timeFrame': '12 weeks', 'description': 'CD14++CD16-'}], 'primaryOutcomes': [{'measure': 'Glucose Time-in-Range', 'timeFrame': '12 weeks', 'description': 'Glucose time 70-180 mg/dL'}], 'secondaryOutcomes': [{'measure': 'Total Daily Insulin Dose', 'timeFrame': '12 weeks', 'description': 'Units of insulin per day'}, {'measure': 'Glucose Time-above-Range', 'timeFrame': '12 weeks', 'description': 'Glucose time \\>180 mg/dL'}, {'measure': 'Glucose Time-Below-Range', 'timeFrame': '12 weeks', 'description': 'Glucose time \\<70 mg/dL'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '12 weeks', 'description': 'measure of glycemic control'}, {'measure': 'Insulin Sensitivity', 'timeFrame': '12 weeks', 'description': 'M-value from euglycemic insulin clamp'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'closed loop technology', 'time-in-range', 'adjunct therapy', 'cardiovascular health'], 'conditions': ['Type 1 Diabetes (T1D)', 'Glycemic Control for Diabetes Mellitus', 'Insulin', 'Ketones', 'Cardiovascular Health']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and/or lower total daily insulin dose in people with type 1 diabetes who are using closed-loop automated insulin delivery. Researchers will compare CIR-0602K to a placebo (a look-alike substance that contains no drug) to see if it achieves the investigational endpoints. If the study results show that the drug works to increase time-in-range and lower insulin doses, this will lead to further studies which may then make the drug available to the public.', 'detailedDescription': 'Participants in the study will:\n\n* Come to the Clinical Research Unit (CRU) at UVA Medical Center for 3 visits: Screening, Baseline (Admission 1) and End-of-Study (Admission 2).\n* Complete various tests of cardiovascular health at each visit.\n* Take either an experimental drug (CIR-0602K) or placebo for 12 weeks.\n* Wear a study CGM with their personal insulin pump for 12 weeks.\n* Be given a ketone meter and strips and be asked to take a fingerstick ketone reading every morning for 12 weeks.\n* The study team will contact the participants regularly during the study to check their health and how they are tolerating the study drug/placebo.\n* Return the study CGM, ketone meter, and remaining supplies, etc. at the end of the study.\n* Notify the study team of any illness, injury, hypoglycemic or hyperglycemic events during the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. History of type 1 diabetes for at least one year\n4. Age 18-45 years\n5. HbA1c \\<10%\n\n * BMI 18-35 kg/m2. Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units/kg/day.\n * Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM.\n * On stable regimen of non-diabetic medications for the last 6 months.\n * All screening labs within normal limits or not clinically significant.\n * Ability to take oral medication and be willing to adhere to the study drug/placebo for 12 weeks.\n * For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 2 weeks after the end of CIR-0602K administration.\n * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study intervention.\n * Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n* Current Pregnancy or currently breastfeeding.\n* History of smoking tobacco products within the last two years.\n* History of alcohol abuse or illicit drug abuse within 6 months of screening.\n* Known history of human immunodeficiency virus (HIV).\n* History of other significant disease (e.g., cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine) that could, in the investigator's view, alter study outcomes\n* Any surgical or medical condition which may significantly alter the absorption of the study drug including but not limited to the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome.\n* Current use of any antihyperglycemic medication beyond insulin (i.e., GLP-1 receptor agonists, SGLT2 inhibitors, etc.).\n* Unstable doses (i.e., dose change within the last 4 months) of vasoactive medications (e.g., calcium-channel blockers, statins, angiotensin-converting enzyme inhibitors, diuretics, nitrates, alpha-blockers, beta-blockers, etc.).\n* Daily use of anti-inflammatory medications (e.g., ibuprofen, aspirin, prednisone, dexamethasone, etc.).\n* Diagnosis of peripheral neuropathy (assessed by screening monofilament exam).\n* Macroalbuminuria (i.e., urine albumin: creatinine \\>300 mg per g).\n* Retinopathy beyond mild, nonproliferative retinopathy.\n* History of Level 3 hypoglycemia within the last 12 months.\n* History of diabetic ketoacidosis (DKA) within the last 12 months.\n* Screening electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease.\n* Screening oxygen saturation \\<90%\n* History of hypersensitivity or prior adverse reaction to the study drug, closely-related compounds, or any of the stated ingredients.\n* Use of concomitant medications with a known significant metabolism by CYP2C8 or CYP2C (including paclitaxel, phenytoin, warfarin, celecoxib, tolbutamide, or repaglinide) for the duration of the study.\n* Participation in an investigational study (other than a non-treatment registry study) or received an investigational drug withing 30 days or 5 half-lives (whichever is longer) prior to randomization."}, 'identificationModule': {'nctId': 'NCT07186660', 'acronym': 'WBH003', 'briefTitle': 'Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Evaluation of a Novel Insulin Sensitizer on Glycemic Control, Insulin Usage, and Cardiovascular Biomarkers in People With Type 1 Diabetes Who Use Closed-loop Automated Insulin Delivery', 'orgStudyIdInfo': {'id': '302645'}, 'secondaryIdInfos': [{'id': '3-SRA-2025-1773-M-B', 'type': 'OTHER_GRANT', 'domain': 'Breakthrough T1D'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CIR-0602K', 'description': 'CIR-0602K 250 mg daily', 'interventionNames': ['Drug: CIR-0602K']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo Tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CIR-0602K', 'type': 'DRUG', 'description': 'mitochondrial pyruvate carrier inhibitor', 'armGroupLabels': ['CIR-0602K']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'contacts': [{'name': 'Horton B Horton, MD', 'role': 'CONTACT', 'email': 'WBH2N@VIRGINIA.EDU', 'phone': '(434) 924-1828'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Lee Hartline, MEd', 'role': 'CONTACT', 'email': 'LMH9D@VIRGINIA.EDU', 'phone': '14349245247'}], 'overallOfficials': [{'name': 'William B. Horton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigative team will finalize the decision (as to whether or not to share IPD) at a later date. Of note, IPD in this study qualifies as protected health information and would thus require safety considerations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'William Horton, MD', 'investigatorAffiliation': 'University of Virginia'}}}}