Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
The purpose of the study is to study the clinical effects of the investigational drug, SB-509 versus placebo in patients with diabetic neuropathy.
SB-509 contains the gene (DNA—a kind of biological "blueprint") for a protein. When a
researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around
the injection site and causes these cells to make a protein. This protein causes your cells
to increase production of another protein called vascular endothelial growth factor (VEGF),
which may improve the structure and function of nerves. In addition, there are changes in
the levels of 28 additional proteins in your cells. These proteins function to promote the
growth of cells, are structures in cells, help synthesize products, and affect immune cells,
and some have unknown functions. This increase in your own VEGF proteins may protect and
repair the damaged nerves caused by diabetic neuropathy.
The study doctor will test SB-509 (60 mg) and placebo. Everyone in this study will receive
intramuscular (IM—directly into the muscle) injections into both legs. This will happen 3
times over about 4 months. Two out of every 3 participants will receive SB-509 and 1 out of
every 3 will receive placebo. You will not know, and the study doctor will not know, whether
you will receive SB-509 or whether you will receive placebo.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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