[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607292":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":85,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CIR-0602K","ACTIVE_COMPARATOR","CIR-0602K 250 mg daily",[13],"Drug: CIR-0602K",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Matching Placebo Tablet",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","mitochondrial pyruvate carrier inhibitor",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo tablet",[15],[30],{"name":31,"affiliation":5,"role":32},"William B. Horton, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Lee Hartline, MEd","CONTACT","14349245247","LMH9D@VIRGINIA.EDU",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Charlottesville","Virginia","22908","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-78.47668,38.02931,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":25,"email":57},"Horton B Horton, MD","(434) 924-1828","WBH2N@VIRGINIA.EDU",{"type":32,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"William Horton, MD","Associate Professor","100607292","phase-2-evaluation-of-a-novel-insulin-sensitizer-in-people-with-type-1-diabetes-100607292",false,"NCT07186660","Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes","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","WBH003","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 \\\u003C10%\n\n   * BMI 18-35 kg\u002Fm2. Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units\u002Fkg\u002Fday.\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\u002Fplacebo 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 \\\u003C90%\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.","ALL","18 Years","45 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","The purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and\u002For 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.",[80,81,82,83,84],"Type 1 Diabetes (T1D)","Glycemic Control for Diabetes Mellitus","Insulin","Ketones","Cardiovascular Health",[86,87,88,89,90],"Type 1 Diabetes","closed loop technology","time-in-range","adjunct therapy","cardiovascular health","2026-02-23",{"date":93,"type":94},"2026-02-25","ACTUAL",{"date":96,"type":94},"2026-02-22",{"date":98,"type":74},"2028-09",{"name":5,"class":6},1]