Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderately Severe Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079325
• Other study ID #: SB-509-0901
• Status: Completed
• Phase: Phase 2
• Start date: November 2009
• Est. completion date: April 2016

Study information

• Verified date: May 2022
• Source: Sangamo Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: April 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies

Intervention

Drug:
• SB-509
SB-509 60 mg, 3 treatments, and 5 months treatment period

Other:
• Saline

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sangamo Therapeutics	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months
Secondary	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		12 months
Secondary	To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD		12 months
Secondary	To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy		12 months

External Links

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