Study of CIR-0602K, a New Insulin Sensitizer, for Improving Blood Sugar Control and Insulin Use in Adults with Type 1 Diabetes Using Automated Insulin Delivery

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.

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