Actively Recruiting
Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes
Led by University of Virginia · Updated on 2026-02-25
40
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 comply with all study procedures and be available for the entire study
- History of type 1 diabetes for at least one year
- Age between 18 and 45 years
- HbA1c less than 10%
- Body mass index (BMI) between 18 and 35 kg/m2, with either BMI at least 25 or total daily insulin dose of at least 0.5 units/kg/day
- Currently using closed-loop automated insulin delivery therapy compatible with Dexcom G7 CGM
- Stable regimen of non-diabetic medications for at least the last 6 months
- All screening laboratory tests within normal limits or not clinically significant
- Ability and willingness to take oral medication and adhere to study drug or placebo for 12 weeks
- For females and males of reproductive potential: agreement to use adequate contraception during the study and for 2 weeks after the study drug period
- For males of reproductive potential: use of condoms or other effective contraception methods during the study
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- Current pregnancy or breastfeeding
- Smoking tobacco products within the last two years
- History of alcohol or illicit drug abuse within 6 months before screening
- Known history of HIV infection
- Significant diseases such as cardiac, cerebrovascular, gastrointestinal, liver, renal, or endocrine conditions that could affect study outcomes
- Major gastrointestinal surgeries or active inflammatory bowel syndrome affecting drug absorption
- Use of antihyperglycemic medications other than insulin
- Unstable doses of vasoactive medications within the last 4 months
- Daily use of anti-inflammatory medications like ibuprofen, aspirin, prednisone, or dexamethasone
- Diagnosis of peripheral neuropathy
- Macroalbuminuria (urine albumin:creatinine ratio over 300 mg/g)
- Retinopathy more severe than mild nonproliferative
- History of severe hypoglycemia or diabetic ketoacidosis within the last 12 months
- ECG abnormalities indicating arrhythmia, sinus node disease, or ischemic heart disease
- Oxygen saturation below 90%
- Known hypersensitivity or adverse reaction 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 prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
L
Lee Hartline, MEd
CONTACT
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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