Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Polyneuropathy
• Interventions: Biological: SB-509; Other: Placebo

• Registration Number: NCT00476931
• Lead Sponsor: Sangamo Therapeutics

Brief Summary

The purpose of the study is to study the clinical effects of the investigational drug, SB-509 versus placebo in patients 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 28 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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-18
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-22
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Status Verified: 2012-10
• Disposition First Submitted: 2012-10-30
• Disposition First Submitted QC: 2012-10-30
• Last Update Submitted: 2012-10-30
• Disposition First Posted: 2012-11-01
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Key Inclusion Criteria:

• Have a clinical diagnosis of diabetes mellitus type I or II for at least 12 months prior to the study.
• Have received a diagnosis of moderate to severe sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). This type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. Subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.
• Unmeasurable nerve conduction velocity in any lower extremity nerve: peroneal, tibial or sural due to diabetic polyneuropathy
• If female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.
• Have blood pressure < 140/90 mm Hg
• Body mass index (BMI) < 38 kg/m2

Key

Exclusion Criteria

Subjects with the following are NOT eligible to participate in this study:

• Have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) within the previous 6 months.
• Have chronic foot or leg ulcers for >1 month, gangrene in the legs, or any previous amputation of the lower extremity.
• Have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
• Have colon polyps. If patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months.
• Require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards.
• Have a known disorder that affects patients' immune systems (such as HIV/AIDS, hepatitis B virus [HBV], hepatitis C virus [HCV], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SB-509	SB-509
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Total Neuropathy Score (TNS),Evoked nerve conduction velocity (NCV), Quantitative Sensory Testing (QST), %of subjects with conversion of unmeasurable to measurable NCV and NIS-LL	One year

Secondary Outcome Measures

Name	Time	Method
Safety	One year

Trial Locations

Locations (20)

Laszlo J. Mate', M.D.; 🇺🇸 West Palm Beach, Florida, United States

Upstate Clinical Research; 🇺🇸 Albany, New York, United States

Nerve and Muscle Center of Texas; 🇺🇸 Houston, Texas, United States

Advanced Biomedical Research of America; 🇺🇸 Las Vegas, Nevada, United States

Torrance Clinical Research; 🇺🇸 Lomita, California, United States

Coordinated Clinical Research; 🇺🇸 La Jolla, California, United States

SF Clinical Research Center; 🇺🇸 San Francisco, California, United States

Advanced Medical Research, LLC; 🇺🇸 Lakewood, California, United States

Bradenton Research Center; 🇺🇸 Bradenton, Florida, United States

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

Neurology Clinical Research; 🇺🇸 Sunrise, Florida, United States

Creighton Diabetes Center; 🇺🇸 Omaha, Nebraska, United States

Peripheral Neuropathy Center, Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Neurological Institute Columbia University College of Physicians and Surgeons; 🇺🇸 New York, New York, United States

Instituto Mexicano de Investigación Clinica; 🇲🇽 Mexico City, Col. Roma, Mexico

Diabetes Center of the Southwest; 🇺🇸 Midland, Texas, United States

DGD Research; 🇺🇸 San Antonio, Texas, United States

Rainier Clinical Research Center; 🇺🇸 Renton, Washington, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States