Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy - Full Text View

Sponsors and Collaborators:	Sangamo Biosciences Juvenile Diabetes Research Foundation
Information provided by:	Sangamo Biosciences
ClinicalTrials.gov Identifier:	NCT00406458

Purpose

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

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetic Nerve Problems

U.S. FDA Resources

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

Further study details as provided by Sangamo Biosciences:

Primary Outcome Measures:

Visual analog scale for pain intensity (VASPI), Nerve Conduction Velocity (NCV), Total Neuropathy Score (TNS), Epidermal Nerve Fiber Density (ENFD) & Epidermal Nerve Fiber Density Regeneration (ENFDR) [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]

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	Biological: SB-509 60 mg dose
2: Placebo Comparator	Biological: Placebo Normal saline

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Have a clinical diagnosis of diabetes mellitus type I or II for at least 12 months prior to the study.
Have received a diagnosis of mild to moderate sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). This type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. Subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.
If female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.
Have blood pressure < 140/90 mm Hg
Body mass index (BMI) < 38 kg/m2

Key Exclusion Criteria:

Subjects with the following are NOT eligible to participate in this study:

Have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) within the previous 6 months.
Have chronic foot or leg ulcers for >1 month, gangrene in the legs, or any previous amputation of the lower extremity.
Have symptoms of intermittent claudication (or leg pain during exercise associated with peripheral artery disease) and/or an ankle brachial index (or a calculation of the difference between arm and leg blood pressures) of less than (<) 0.75.
Have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
Have colon polyps. If patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months.
Require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards.
Have a known disorder that affects patients' immune systems (such as HIV/AIDS, hepatitis B virus [HBV], hepatitis C virus [HCV], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406458

Locations

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

Sponsors and Collaborators

Sangamo Biosciences

Juvenile Diabetes Research Foundation

More Information

Sponsor website This link exits the ClinicalTrials.gov site

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

Keywords provided by Sangamo Biosciences:

Diabetic neuropathy
Diabetes Type I or II
Mild to moderate sensorimotor diabetic polyneuropathy

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009