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Sponsors and Collaborators: |
Sangamo Biosciences Juvenile Diabetes Research Foundation |
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Information provided by: | Sangamo Biosciences |
ClinicalTrials.gov Identifier: | NCT00406458 |
The purpose of the study is to study the clinical effects of the investigational drug, SB-509 versus placebo in patients with diabetic neuropathy.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetic Polyneuropathy |
Biological: SB-509 Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy |
Estimated Enrollment: | 102 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
SB-509
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Biological: SB-509
60 mg dose
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2: Placebo Comparator |
Biological: Placebo
Normal saline
|
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects with the following are NOT eligible to participate in this study:
United States, California | |
Diablo Clinical Research | |
Walnut Creek, California, United States, 94598 | |
Coordinated Clinical Research | |
La Jolla, California, United States, 92037 | |
SF Clinical Research Center | |
San Francisco, California, United States, 94109 | |
Advanced Medical Research, LLC | |
Lakewood, California, United States, 90712 | |
United States, Florida | |
Bradenton Research Center | |
Bradenton, Florida, United States, 34205 | |
Neurology Clinical Research | |
Sunrise, Florida, United States, 33351 | |
University of Miami, Diabetes Research Institute | |
Miami, Florida, United States, 33136 | |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Nebraska | |
Creighton Diabetes Center | |
Omaha, Nebraska, United States, 68131 | |
United States, New York | |
Upstate Clinical Research | |
Albany, New York, United States, 12205 | |
Peripheral Neuropathy Center, Weill Medical College of Cornell University | |
New York, New York, United States, 10022 | |
United States, Pennsylvania | |
Altoona Center for Clinical Research | |
Duncansville, Pennsylvania, United States, 16635 | |
United States, Texas | |
Nerve and Muscle Center of Texas | |
Houston, Texas, United States, 77030 | |
DGD Research | |
San Antonio, Texas, United States, 78229 | |
Mexico, Col. Roma | |
Instituto Mexicano de Investigación Clinica | |
Mexico City, Col. Roma, Mexico, 06700 |
Responsible Party: | Sangamo BioSciences, Inc. ( Ely Benaim, M.D., Vice President, Clinical Affairs ) |
Study ID Numbers: | SB-509-0601 |
Study First Received: | November 30, 2006 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00406458 |
Health Authority: | United States: Food and Drug Administration |
Diabetic neuropathy Diabetes Type I or II Mild to moderate sensorimotor diabetic polyneuropathy |
Metabolic Diseases Autoimmune Diseases Diabetic Neuropathies Polyneuropathies Diabetes Mellitus Endocrine System Diseases Diabetes Mellitus, Type 1 |
Neuromuscular Diseases Peripheral Nervous System Diseases Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Diabetes Complications |
Immune System Diseases Nervous System Diseases |