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Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes

NCT07186660 · University of Virginia
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Official title
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
About this study
Participants in the study will: * Come to the Clinical Research Unit (CRU) at UVA Medical Center for 3 visits: Screening, Baseline (Admission 1) and End-of-Study (Admission 2). * Complete various tests of cardiovascular health at each visit. * Take either an experimental drug (CIR-0602K) or placebo for 12 weeks. * Wear a study CGM with their personal insulin pump for 12 weeks. * Be given a ketone meter and strips and be asked to take a fingerstick ketone reading every morning for 12 weeks. * The study team will contact the participants regularly during the study to check their health and how they are tolerating the study drug/placebo. * Return the study CGM, ketone meter, and remaining supplies, etc. at the end of the study. * Notify the study team of any illness, injury, hypoglycemic or hyperglycemic events during the study
Eligibility criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. History of type 1 diabetes for at least one year 4. Age 18-45 years 5. HbA1c \<10% * 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. * Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM. * On stable regimen of non-diabetic medications for the last 6 months. * All screening labs within normal limits or not clinically significant. * Ability to take oral medication and be willing to adhere to the study drug/placebo for 12 weeks. * 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. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study intervention. * Agreement to adhere to Lifestyle Considerations throughout study duration. Exclusion Criteria: * Current Pregnancy or currently breastfeeding. * History of smoking tobacco products within the last two years. * History of alcohol abuse or illicit drug abuse within 6 months of screening. * Known history of human immunodeficiency virus (HIV). * History of other significant disease (e.g., cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine) that could, in the investigator's view, alter study outcomes * 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. * Current use of any antihyperglycemic medication beyond insulin (i.e., GLP-1 receptor agonists, SGLT2 inhibitors, etc.). * 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.). * Daily use of anti-inflammatory medications (e.g., ibuprofen, aspirin, prednisone, dexamethasone, etc.). * Diagnosis of peripheral neuropathy (assessed by screening monofilament exam). * Macroalbuminuria (i.e., urine albumin: creatinine \>300 mg per g). * Retinopathy beyond mild, nonproliferative retinopathy. * History of Level 3 hypoglycemia within the last 12 months. * History of diabetic ketoacidosis (DKA) within the last 12 months. * Screening electrocardiogram (ECG) findings indicative of arrhythmia, sinus node disease, or ischemic heart disease. * Screening oxygen saturation \<90% * History of hypersensitivity or prior adverse reaction to the study drug, closely-related compounds, or any of the stated ingredients. * 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. * 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.
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: quadruple
Age groups: adult
Timeline
Starts: 2026-02-22
Estimated completion: 2028-09
Last updated: 2026-02-25
Interventions
Drug: CIR-0602KDrug: Placebo
Primary outcomes
  • Glucose Time-in-Range (12 weeks)
Sponsor
University of Virginia · other
Contacts & investigators
ContactLee Hartline, MEd · contact · LMH9D@VIRGINIA.EDU · 14349245247
InvestigatorWilliam B. Horton, MD · principal_investigator, University of Virginia
All locations (1)
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes · TrialPath