Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03163511 | A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness | PHASE1 | COMPLETED | 49 | — | — | Jul 6, 2017 | Oct 19, 2023 | Dec 3, 2024 | 10 | United States, Belgium +1 |
Incidence of all AEs and evaluation of causality related to VC-02 combination product, the surgical procedures, and the immunosuppressive drug regimen.
Change from baseline to Week 26 in C-peptide area under the curve from 0 to 4 hours following a mixed meal tolerance test.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | VC-02 Combination Product: Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants |
| Cohort 2 | EXPERIMENTAL | VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants. |
| Name | Type | Description |
|---|---|---|
| VC-02 Combination Product | COMBINATION_PRODUCT | PEC-01 cells loaded into a Delivery Device |
Inclusion Criteria: * Men and non-pregnant women * Diagnosis of T1DM for a minimum of five (5) years * Hypoglycemia unawareness or significant glycemic lability * Stable diabetic treatment * Willingness to use a continuous glucose meter * Acceptable candidate for implantation Exclusion Criteria: ...