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

Status:	Recruiting
Conditions:	Endocrine, Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 65
Updated:	1/10/2019
Start Date:	July 6, 2017
End Date:	December 2020

An Open-Label, First-In-Human Study Evaluating the Safety, Tolerability, and Efficacy of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

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.

Inclusion Criteria:

- Men and non-pregnant women of non-childbearing potential

- Diagnosis of T1DM for a minimum of five (5) years

- At least one (1) severe hypoglycemic event in previous 12 months

- 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

We found this trial at

sites

Ohio State University

281 W. Lane Ave
Columbus, Ohio 43210

(614) 292-6446