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

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

This 12-week test will see if the oral drug CIR-0602K helps adults with type 1 diabetes who use closed-loop insulin systems spend more time in their target glucose range and use less insulin.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: University of Virginia (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT07186660 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–45 with at least one year of type 1 diabetes, HbA1c under 10%, BMI 18–35 with either BMI ≥25 or total daily insulin ≥0.5 units/kg, and who currently use a closed-loop AID system compatible with Dexcom G7 are the intended participants.

Not a fit: People outside the 18–45 age range, those with HbA1c ≥10%, not using compatible closed-loop systems, or with medical contraindications are unlikely to be eligible or benefit from this trial.

Why it matters

Potential benefit: If successful, the drug could increase time-in-range and lower daily insulin needs, potentially improving daily glucose control and reducing insulin burden for people with type 1 diabetes.

How similar studies have performed: Adjunct therapies to improve insulin sensitivity or time-in-range in type 1 diabetes have shown mixed results historically, and this specific insulin-sensitizing agent is relatively novel and unproven in this population.

Eligibility criteria

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 this trial is running

Charlottesville, Virginia

• University of Virginia — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: William B. Horton, MD — University of Virginia
• Study coordinator: Lee Hartline, MEd

Conditions Type 1 Diabetes; Glycemic Control for Diabetes Mellitus; Insulin; Ketones; Cardiovascular Health; closed loop technology; time-in-range; adjunct therapy