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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Virginia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • CIR-0602K

    Drug

    mitochondrial pyruvate carrier inhibitor

  • Placebo

    Drug

    Placebo tablet

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CIR-0602KActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glucose Time-in-Range

Glucose time 70-180 mg/dL

Time frame
12 weeks

Secondary outcomes

1

Total Daily Insulin Dose

Units of insulin per day

Time frame
12 weeks
2

Glucose Time-above-Range

Glucose time \>180 mg/dL

Time frame
12 weeks
3

Glucose Time-Below-Range

Glucose time \<70 mg/dL

Time frame
12 weeks
4

Hemoglobin A1c

measure of glycemic control

Time frame
12 weeks

Other outcomes

1

Brachial Artery Flow-Mediated Dilation

Noninvasive measurement of blood vessel function

Time frame
12 weeks
2

Carotid-Femoral Pulse Wave Velocity

Noninvasive measure of aortic stiffness

Time frame
12 weeks
3

Radial Artery Augmentation Index

Noninvasive measure of radial artery stiffness

Time frame
12 weeks
4

C-peptide

Blood test that measures endogenous insulin secretion

Time frame
12 weeks

Sponsors and contacts

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