About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
History of type 1 diabetes for at least one year
Age 18-45 years
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
CIR-0602K
Drugmitochondrial pyruvate carrier inhibitor
Placebo
DrugPlacebo tablet
Treatment groups
Trial outcomes
Primary outcomes
Glucose Time-in-Range
Glucose time 70-180 mg/dL
Secondary outcomes
Total Daily Insulin Dose
Units of insulin per day
Glucose Time-above-Range
Glucose time \>180 mg/dL
Glucose Time-Below-Range
Glucose time \<70 mg/dL
Hemoglobin A1c
measure of glycemic control
Other outcomes
Brachial Artery Flow-Mediated Dilation
Noninvasive measurement of blood vessel function
Carotid-Femoral Pulse Wave Velocity
Noninvasive measure of aortic stiffness
Radial Artery Augmentation Index
Noninvasive measure of radial artery stiffness
C-peptide
Blood test that measures endogenous insulin secretion
Sponsors and contacts
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