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

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.