Actively Recruiting
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
Led by University of Virginia · Updated on 2026-02-25
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a novel insulin sensitizer, CIR-0602K, in adults with type 1 diabetes who use closed-loop automated insulin delivery systems. The study aims to see if CIR-0602K can improve glucose time-in-range and reduce total daily insulin doses compared to a placebo. This phase 2 trial is sponsored by the University of Virginia and focuses on glycemic control and cardiovascular health outcomes. Participants will be randomly assigned to receive either CIR-0602K 250 mg daily or a matching placebo tablet for 12 weeks. They will continue using their personal insulin pump alongside a continuous glucose monitor (CGM) to track glucose levels. The study includes three visits to the Clinical Research Unit: screening, baseline, and end-of-study. During the study, participants will measure ketones daily using a provided meter and strips. Throughout the trial, participants will undergo cardiovascular health tests and report any health changes or events such as hypoglycemia or hyperglycemia. The study team will regularly check on participants to monitor their health and adherence to the study medication. Researchers will measure glucose time-in-range as the primary outcome at 12 weeks, along with insulin dose, glucose variability, hemoglobin A1c, and insulin sensitivity. The total participation lasts about 12 weeks of treatment plus study visits.
CONDITIONS
Brief Title
Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and be available for the study duration
- Diagnosis of type 1 diabetes for at least one year
- Age between 18 and 45 years
- Hemoglobin A1c less than 10%
- Body mass index between 18 and 35 kg/m2, with BMI ≥25 or total daily insulin dose ≥0.5 units/kg/day
- Currently using a closed-loop automated insulin delivery system compatible with Dexcom G7 CGM
- Stable regimen of non-diabetic medications for at least 6 months
- Normal or non-significant screening lab results
- Ability and willingness to take oral medication for 12 weeks
- Agreement to use adequate contraception during and for 2 weeks after the study for females and males of reproductive potential
- Males must use condoms or other effective contraception methods with partners during the study
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- Current pregnancy or breastfeeding
- Smoking history within the last 2 years
- Alcohol or illicit drug abuse within 6 months
- Known HIV infection
- Significant other diseases that could affect study outcomes
- Conditions affecting drug absorption, including major gastrointestinal surgeries or active inflammatory bowel syndrome
- Use of antihyperglycemic medications other than insulin
- Unstable doses of vasoactive medications in the last 4 months
- Daily use of anti-inflammatory medications
- Diagnosis of peripheral neuropathy
- Macroalbuminuria (urine albumin:creatinine >300 mg/g)
- Retinopathy more severe than mild nonproliferative
- History of severe hypoglycemia or diabetic ketoacidosis in the last 12 months
- Abnormal screening ECG indicating arrhythmia or heart disease
- Oxygen saturation below 90%
- Hypersensitivity to the study drug or related compounds
- Use of medications metabolized significantly by CYP2C8 or CYP2C during the study
- Participation in another investigational drug study within 30 days or 5 half-lives before randomization
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take either the experimental drug CIR-0602K or a placebo daily, wear a study continuous glucose monitor (CGM) with their personal insulin pump, and monitor ketone levels each morning.
2 visits (Baseline and End-of-Study, in-person) with regular health check contacts during treatment
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
L
Lee Hartline, MEd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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