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Evaluating CIR-0602K for Type 1 Diabetes

This study is looking into whether a drug called CIR-0602K can help people with Type 1 Diabetes (T1D) better manage their blood sugar. Specifically, researchers want to see if CIR-0602K can increase the "time-in-range" (the amount of time your blood sugar stays within a healthy target) and/or lower the daily amount of insulin you need. You might be able to join if you are 18-45 years old, have had T1D for at least a year, and meet certain health criteria like an HbA1c (a measure of average blood sugar) below 10%. The study will compare CIR-0602K to a placebo (an inactive pill) over 12 weeks. The goal is to see if CIR-0602K is effective enough to move forward to larger studies, potentially making it available to the public.

Study design
This is an interventional study comparing CIR-0602K to a placebo. It plans to enroll 40 participants.
What's involved
You would visit the study center three times and take either CIR-0602K or a placebo for 12 weeks. You would also wear a continuous glucose monitor (CGM) and take daily ketone readings.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 weeks, which is the duration of the intervention.

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NCT07186660

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

Recruiting
PHASE2Ages 18–45InterventionalTreatment
University of Virginia
~40 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:CIR-0602KPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glucose Time-in-Range
Measured over 12 weeks

Conditions

Type 1 Diabetes (T1D)
Glycemic Control for Diabetes Mellitus
Insulin
Ketones
Cardiovascular Health

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • William B. Horton, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Lee Hartline, MEd
[email protected]
14349245247
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Glucose Time-in-Range12 weeks

    Glucose time 70-180 mg/dL