A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/10/2019 |
| Start Date: | September 2014 |
| End Date: | January 2021 |
A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus
The purpose of this trial is to test if VC-01™ combination product can be implanted
subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will
also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.
subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will
also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.
Inclusion Criteria:
- Men and women (non-pregnant and non-childbearing potential)
- Diagnosis of type 1 diabetes mellitus for at least 3 years
- Stable diabetic treatment
- Willingness to use a continuous glucose meter
- Acceptable candidate for implantation
Exclusion Criteria:
- Advanced complications associated with diabetes
- Immunosuppressive therapy
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