A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Phase 1
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Combination Product: VC-02 Combination Product (aka PEC-Direct)
- Registration Number
- NCT03162926
- Lead Sponsor
- ViaCyte
- Brief Summary
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4) months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
- Men and non-pregnant women of non-childbearing potential
- Diagnosis of T1DM for a minimum of five (5) years
- 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.
- Two (2) 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-group VC-02 Combination Product (aka PEC-Direct) Up to six (6) VC-02-20 implants
- Primary Outcome Measures
Name Time Method Incidence of all adverse events reported for subjects Thru the Month 4 Visit]
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada