Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Polyneuropathy

In brief

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

Key facts

Study ID

NCT00476931

Run by

Sangamo Therapeutics

People needed

91

Starts

2007-05-01

Expected to finish

2010-12-01

Last updated by the study team

2012-11-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

Where it is running

• Coordinated Clinical Research — La Jolla, California, United States
• Advanced Medical Research, LLC — Lakewood, California, United States
• Torrance Clinical Research — Lomita, California, United States
• SF Clinical Research Center — San Francisco, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Bradenton Research Center — Bradenton, Florida, United States
• Neurology Clinical Research — Sunrise, Florida, United States
• Laszlo J. Mate', M.D. — West Palm Beach, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Creighton Diabetes Center — Omaha, Nebraska, United States
• Advanced Biomedical Research of America — Las Vegas, Nevada, United States
• Upstate Clinical Research — Albany, New York, United States
• Peripheral Neuropathy Center, Weill Medical College of Cornell University — New York, New York, United States
• Neurological Institute Columbia University College of Physicians and Surgeons — New York, New York, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Nerve and Muscle Center of Texas — Houston, Texas, United States
• Diabetes Center of the Southwest — Midland, Texas, United States
• DGD Research — San Antonio, Texas, United States
• Rainier Clinical Research Center — Renton, Washington, United States
• Instituto Mexicano de Investigación Clinica — Mexico City, Col. Roma, Mexico

Full record on ClinicalTrials.gov

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