A new insulin-sensitizing pill for adults with type 1 diabetes using closed‑loop insulin delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled Phase 2 trial enrolling adults with type 1 diabetes who use closed-loop automated insulin delivery compatible with the Dexcom G7. Participants will take either CIR-0602K or a matched placebo for 12 weeks while wearing a continuous glucose monitor and using their personal insulin pump. The study includes three in-person visits (screening, baseline admission, and end-of-study admission), regular remote contacts, daily ketone monitoring, and cardiovascular testing at visits. Primary outcomes focus on time-in-range and total daily insulin dose with safety and tolerability monitored throughout.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: William B. Horton, MD — University of Virginia
• Study coordinator: Lee Hartline, MEd
• Email: LMH9D@VIRGINIA.EDU
• Phone: 14349245247

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.