Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT07186660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Insulin Sensitizer in People With Type 1 Diabetes
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WBH003
Brief Summary:
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.
Detailed Description:
Participants in the study will:
* Come to the Clinical Research Unit (CRU) at UVA Medical Center for 3 visits: Screening, Baseline (Admission 1) and End-of-Study (Admission 2).
* Complete various tests of cardiovascular health at each visit.
* Take either an experimental drug (CIR-0602K) or placebo for 12 weeks.
* Wear a study CGM with their personal insulin pump for 12 weeks.
* Be given a ketone meter and strips and be asked to take a fingerstick ketone reading every morning for 12 weeks.
* The study team will contact the participants regularly during the study to check their health and how they are tolerating the study drug/placebo.
* Return the study CGM, ketone meter, and remaining supplies, etc. at the end of the study.
* Notify the study team of any illness, injury, hypoglycemic or hyperglycemic events during the study
* Come to the Clinical Research Unit (CRU) at UVA Medical Center for 3 visits: Screening, Baseline (Admission 1) and End-of-Study (Admission 2).
* Complete various tests of cardiovascular health at each visit.
* Take either an experimental drug (CIR-0602K) or placebo for 12 weeks.
* Wear a study CGM with their personal insulin pump for 12 weeks.
* Be given a ketone meter and strips and be asked to take a fingerstick ketone reading every morning for 12 weeks.
* The study team will contact the participants regularly during the study to check their health and how they are tolerating the study drug/placebo.
* Return the study CGM, ketone meter, and remaining supplies, etc. at the end of the study.
* Notify the study team of any illness, injury, hypoglycemic or hyperglycemic events during the study
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 3-SRA-2025-1773-M-B | OTHER_GRANT | Breakthrough T1D | View |