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 19, 2016
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Sangamo Therapeutics

March 2, 2010
March 3, 2010
April 19, 2016
November 2009
May 2015   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01079325 on Archive Site
  • 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 ]
Same as current
Not Provided
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Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderately Severe Diabetic Neuropathy
The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Diabetic Polyneuropathy
  • Drug: SB-509
    SB-509 60 mg, 3 treatments, and 5 months treatment period
  • Other: Saline
    Other Name: 30 ml saline, 3 treatments
  • Experimental: SB-509
    Intervention: Drug: SB-509
  • Placebo Comparator: Placebo
    Intervention: Other: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2016
May 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Sangamo Therapeutics
Sangamo Therapeutics
Juvenile Diabetes Research Foundation
Study Director: Winson Tang, MD Sangamo BioSciences, Inc
Sangamo Therapeutics
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP