NCT00476931

Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderate to Severe Diabetic Neuropathy and Unmeasurable Nerve Conduction Velocity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Sangamo Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to study the clinical effects of the investigational drug, SB-509 versus placebo in patients with diabetic neuropathy.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetic Polyneuropathy

Interventions

Type	Name	Description
BIOLOGICAL	SB-509	60 mg dose
OTHER	Placebo	Saline

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2007-05-22
• Last updated: 2012-11-01

Locations

20 sites across 2 countries: United States, Mexico