Clinical trial NCT01079325: Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Official title: A Phase 2b Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderately Severe Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Polyneuropathy
Keywords: Diabetic neuropathy
Diabetes Type 1 or 2
Moderately severe sensorimotor diabetic polyneuropathy
Lead sponsor: Sangamo Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2010-03-03
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
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
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD
timeFrame: 12 months
measure: To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Chino
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: National City
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: DeLand
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Idaho Falls
country: United States
state: Idaho
city: Meridian
country: United States
state: Idaho
city: Lexington
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Winston-Salem
country: United States
state: North Carolina
city: Tulsa
country: United States
state: Oklahoma
city: Greer
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Sangamo BioSciences, Inc
name: Winson Tang, MD
role: STUDY_DIRECTOR
References: