Clinical trial NCT00406458: Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Official title: A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With 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 I or II
Mild to moderate sensorimotor diabetic polyneuropathy
Lead sponsor: Sangamo Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2006-12-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 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.

The study doctor will test SB-509 (60 mg) and placebo. Everyone in this study will receive intramuscular (IM-directly into the muscle) injections into both legs. This will happen 3 times over about 4 months. Two out of every 3 participants will receive SB-509 and 1 out of every 3 will receive placebo. You will not know, and the study doctor will not know, whether you will receive SB-509 or whether you will receive placebo.

Eligibility 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 mild to moderate 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.
* 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 symptoms of intermittent claudication (or leg pain during exercise associated with peripheral artery disease) and/or an ankle brachial index (or a calculation of the difference between arm and leg blood pressures) of less than (\<) 0.75.
* 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).

Primary outcomes:
measure: Visual analog scale for pain intensity (VASPI), Nerve Conduction Velocity (NCV), Total Neuropathy Score (TNS), Epidermal Nerve Fiber Density (ENFD) & Epidermal Nerve Fiber Density Regeneration (ENFDR)
timeFrame: One year
Secondary outcomes:
measure: Safety
timeFrame: One year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Coordinated Clinical Research
state: California
city: Lakewood
country: United States
facility: Advanced Medical Research, LLC
state: California
city: San Francisco
country: United States
facility: SF Clinical Research Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Miami
country: United States
facility: University of Miami, Diabetes Research Institute
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Albany
country: United States
facility: Upstate Clinical Research
state: New York
city: New York
country: United States
facility: Peripheral Neuropathy Center, Weill Medical College of Cornell University
state: New York
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Houston
country: United States
facility: Nerve and Muscle Center of Texas
state: Texas
city: San Antonio
country: United States
facility: DGD Research
state: Texas
city: Mexico City
country: Mexico
facility: Instituto Mexicano de Investigación Clinica
state: Col. Roma
Study officials:
References: