Phase 2
Completed N=49
A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
Type 1 Diabetes Mellitus With Hypoglycemia
Source: ClinicalTrials.gov NCT03163511 ↗
Enrolled (actual)
49
Serious AEs
38.8%
Results posted
Dec 2024
Primary outcomePrimary: Incidence of All AEs in Cohort 1 Participants — 33; 2; 24; 8 Adverse Events
Summary
VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of All AEs in Cohort 1 Participants |
33; 2; 24; 8 | — |
| PRIMARY Change in C-peptide for Cohort 2 Subjects |
.1292 | — |
Eligibility Criteria
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
- History of islet cell, kidney, and/or pancreas transplant.
- Six (6) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
- Uncontrolled or untreated thyroid disease or adrenal insufficiency
- Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
- Non-compliance with current anti-diabetic regimen
- Detectable stimulated serum C-peptide during screening period assessment.
Data sourced from ClinicalTrials.gov (NCT03163511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.