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
1 other identifier
interventional
170
1 country
31
Brief Summary
The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2009
Longer than P75 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 2, 2010
CompletedFirst Posted
Study publicly available on registry
March 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 23, 2022
May 1, 2022
5.5 years
March 2, 2010
May 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
6 months
Secondary Outcomes (3)
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
To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD
12 months
To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy
12 months
Study Arms (2)
SB-509
EXPERIMENTALPlacebo
PLACEBO COMPARATORSaline
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sangamo Therapeuticslead
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (31)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Chino, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
National City, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Boulder, Colorado, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Meridian, Idaho, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Dallas, Texas, United States
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Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Winson Tang, MD
Sangamo BioSciences, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2010
First Posted
March 3, 2010
Study Start
November 1, 2009
Primary Completion
May 1, 2015
Study Completion
April 1, 2016
Last Updated
May 23, 2022
Record last verified: 2022-05