An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
| Registry | NCT03162926 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 3 (Actual) |
| Sponsor | ViaCyte (Industry) |
| Conditions | Type 1 Diabetes Mellitus |
| Interventions | VC-02 Combination Product (aka PEC-Direct) (Combination product) |
| Dates | start 2017-07-05, primary completion 2018-02-15, completion 2018-02-15, first posted 2017-05-22, last updated 2018-10-18 |
| Locations | 1 site in Canada |
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All trials for Type 1 Diabetes Mellitus All trials of VC-02 Combination Product (aka PEC-Direct)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Single-group | Experimental | Combination Product: VC-02 Combination Product (aka PEC-Direct) | Up to six (6) VC-02-20 implants |
Sex: All, ages: 18 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Alberta | Edmonton, Alberta | Canada |