Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes
WBH003
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedStudy Start
First participant enrolled
February 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
February 25, 2026
February 1, 2026
2.5 years
September 12, 2025
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose Time-in-Range
Glucose time 70-180 mg/dL
12 weeks
Secondary Outcomes (5)
Total Daily Insulin Dose
12 weeks
Glucose Time-above-Range
12 weeks
Glucose Time-Below-Range
12 weeks
Hemoglobin A1c
12 weeks
Insulin Sensitivity
12 weeks
Other Outcomes (7)
Brachial Artery Flow-Mediated Dilation
12 weeks
Carotid-Femoral Pulse Wave Velocity
12 weeks
Radial Artery Augmentation Index
12 weeks
- +4 more other outcomes
Study Arms (2)
CIR-0602K
ACTIVE COMPARATORCIR-0602K 250 mg daily
Placebo
PLACEBO COMPARATORMatching Placebo Tablet
Interventions
Eligibility Criteria
You may qualify if:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- History of type 1 diabetes for at least one year
- Age 18-45 years
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William B. Horton, MD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Clinical research team
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 12, 2025
First Posted
September 22, 2025
Study Start
February 22, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02