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COMPLETEDPHASE2

Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderate to Severe Diabetic Neuropathy and Unmeasurable Nerve Conduction Velocity

NCT00476931•Sangamo Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

•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).

Locations (20)

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

Key Dates

Start Date

May 1, 2007

Primary Completion Date

July 1, 2010

Completion Date

December 1, 2010

Last Updated

November 1, 2012

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic Polyneuropathy

Interventions

SB-509

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

Inclusion Criteria

Exclusion Criteria

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

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Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes