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Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079325
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : April 22, 2020
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Sangamo Therapeutics

Brief Summary:
The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderately Severe Diabetic Neuropathy
Study Start Date : November 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD [ Time Frame: 12 months ]
  3. To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01079325

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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 Myers, 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
Meridian, 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
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Study Director: Winson Tang, MD Sangamo BioSciences, Inc
Additional Information:
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Responsible Party: Sangamo Therapeutics Identifier: NCT01079325    
Other Study ID Numbers: SB-509-0901
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2016
Keywords provided by Sangamo Therapeutics:
Diabetic neuropathy
Diabetes Type 1 or 2
Moderately severe sensorimotor diabetic polyneuropathy
Additional relevant MeSH terms:
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Diabetic Neuropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications