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Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

This study has been completed.
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Sangamo Therapeutics Identifier:
First received: March 2, 2010
Last updated: April 18, 2016
Last verified: April 2016
The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Polyneuropathy
Drug: SB-509
Other: Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderately Severe Diabetic Neuropathy

Resource links provided by NLM:

Further study details as provided by Sangamo Therapeutics:

Primary Outcome Measures:
  • To compare the effect of SB-509 versus placebo in subjects with moderately severe diabetic neuropathy (DN) on sural Nerve Conduction Velocity (NCV) at six-months [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • To evaluate the effect of SB-509 on Neuropathy Impairment Score - Lower Limb (NIS-LL), motor Nerve Conduction Velocity (NCV), Quantitative Sensory Testing (QST), Intraepidermal Nerve Fiber Density (IENFD), and Lower Extremity Neurological Sensory Exam [ Time Frame: 12 months ]
  • To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD [ Time Frame: 12 months ]
  • To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy [ Time Frame: 12 months ]

Enrollment: 170
Study Start Date: November 2009
Study Completion Date: April 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB-509 Drug: SB-509
SB-509 60 mg, 3 treatments, and 5 months treatment period
Placebo Comparator: Placebo
Other: Saline
Other Name: 30 ml saline, 3 treatments

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 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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months
  • Clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than diabetes
  • Measurable sural and peroneal response bilaterally
  • HgbA1C level ≤ 10%
  • LDL cholesterol ≤ 160 mg/dL
  • Blood pressure ≤ 140/90 mm Hg
  • Body mass index (BMI) ≤ 38

Key Exclusion Criteria:

  • Moderate to severe ischemic heart disease or any history of congestive heart failure, or have had a myocardial infarction within the previous 6 months
  • Evidence of cardiac enlargement and/or congestive heart failure
  • Current diabetic foot or leg ulcer, gangrene in the lower extremity, or any amputation of the lower extremity
  • History of malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
  • Immune or immunodeficiency disorders or expected to require immunosuppressants for 30 days prior to, during, and for 30 days following administration of the investigational drug product
  • History of or current proliferative retinopathy, macular edema or retinal neovascularization
  • Pre-cancerous conditions or benign tumors which have the potential for clinically significant growth due to VEGF stimulation
  • Family history of inherited neuropathy (e.g. Charcot Marie Tooth, Hereditary Predisposition to Pressure Palsy)
  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 identifier: NCT01079325

  Hide Study Locations
United States, Arizona
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
United States, California
Chino, California, United States
Fresno, California, United States
La Jolla, California, United States
Los Angeles, California, United States
National City, California, United States
San Francisco, California, United States
Walnut Creek, California, United States
United States, Colorado
Boulder, Colorado, United States
United States, Florida
DeLand, Florida, United States
Fort Meyers, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
United States, Idaho
Idaho Falls, Idaho, United States
Meridan, Idaho, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, South Carolina
Greer, South Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Sangamo Therapeutics
Juvenile Diabetes Research Foundation
Study Director: Winson Tang, MD Sangamo BioSciences, Inc
  More Information

Additional Information:
Responsible Party: Sangamo Therapeutics Identifier: NCT01079325     History of Changes
Other Study ID Numbers: SB-509-0901
Study First Received: March 2, 2010
Last Updated: April 18, 2016

Keywords provided by Sangamo Therapeutics:
Diabetic neuropathy
Diabetes Type 1 or 2
Moderately severe sensorimotor diabetic polyneuropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetic Neuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Diabetes Complications processed this record on March 28, 2017