Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sangamo Biosciences
ClinicalTrials.gov Identifier:
NCT00476931
First received: May 18, 2007
Last updated: October 30, 2012
Last verified: October 2012
  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
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderate to Severe Diabetic Neuropathy and Unmeasurable Nerve Conduction Velocity

Resource links provided by NLM:


Further study details as provided by Sangamo Biosciences:

Primary Outcome Measures:
  • Total Neuropathy Score (TNS),Evoked nerve conduction velocity (NCV), Quantitative Sensory Testing (QST), %of subjects with conversion of unmeasurable to measurable NCV and NIS-LL [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 91
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SB-509
Biological: SB-509
60 mg dose
Placebo Comparator: 2
None
Other: Placebo
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.

  Eligibility

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

Inclusion 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 moderate to severe 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.
  • Unmeasurable nerve conduction velocity in any lower extremity nerve: peroneal, tibial or sural due to diabetic polyneuropathy
  • 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476931

Locations
United States, California
Coordinated Clinical Research
La Jolla, California, United States, 92037
Advanced Medical Research, LLC
Lakewood, California, United States, 90712
Torrance Clinical Research
Lomita, California, United States, 90707
SF Clinical Research Center
San Francisco, California, United States, 94109
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Florida
Bradenton Research Center
Bradenton, Florida, United States, 34205
Neurology Clinical Research
Sunrise, Florida, United States, 33351
Laszlo J. Mate', M.D.
West Palm Beach, Florida, United States, 33407
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, Nevada
Advanced Biomedical Research of America
Las Vegas, Nevada, United States, 89123
United States, New York
Upstate Clinical Research
Albany, New York, United States, 12205
Neurological Institute Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
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
Diabetes Center of the Southwest
Midland, Texas, United States, 79705
DGD Research
San Antonio, Texas, United States, 78229
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Mexico
Instituto Mexicano de Investigación Clinica
Mexico City, Col. Roma, Mexico, 06700
Sponsors and Collaborators
Sangamo Biosciences
  More Information

Additional Information:
No publications provided

Responsible Party: Sangamo Biosciences
ClinicalTrials.gov Identifier: NCT00476931     History of Changes
Other Study ID Numbers: SB-509-0701
Study First Received: May 18, 2007
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sangamo Biosciences:
Diabetic neuropathy
Diabetes Type 1 or 2
Moderate to severe sensorimotor diabetic polyneuropathy
Unmeasurable nerve conduction velocity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Neuropathies
Polyneuropathies
Autoimmune Diseases
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on October 21, 2014