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

Purpose

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 Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetes Type 2 Diabetic Nerve Problems

U.S. FDA Resources

Further study details as provided by Sangamo Biosciences:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	November 2009
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	September 2014 (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 Saline	Other: Saline NA 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079325

Show 31 Study Locations

Sponsors and Collaborators

Sangamo Biosciences

Juvenile Diabetes Research Foundation

Investigators

Study Director:

Winson Tang, MD

Sangamo BioSciences, Inc

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sangamo Biosciences
ClinicalTrials.gov Identifier:	NCT01079325 History of Changes
Other Study ID Numbers:	SB-509-0901
Study First Received:	March 2, 2010
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sangamo Biosciences:

Diabetic neuropathy
Diabetes Type 1 or 2
Moderately severe sensorimotor diabetic polyneuropathy

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Neuropathies
Polyneuropathies
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on May 19, 2013