A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

ViaCyte

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 1 Diabetes Mellitus With Hypoglycemia

Treatments: Combination Product: VC-02 Combination Product

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03163511

VC02-101

Details and patient eligibility

About

VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.

Full description

The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Cohort 1

Experimental group

Description:

VC-02 Combination Product: Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants

Treatment:

Combination Product: VC-02 Combination Product

Cohort 2

Experimental group

Description:

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.

Treatment:

Combination Product: VC-02 Combination Product