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

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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
5
sites
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-688-6885
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-614-0905
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-626-4993
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Edmonton, Alberta T6G 2J2
Phone: 780-407-1501
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Edmonton,
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San Diego, California 92093
Phone: 844-317-7836
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San Diego, CA
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