Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406458
• Other study ID #: SB-509-0601
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2006
• Last updated: October 30, 2012
• Start date: November 2006
• Est. completion date: May 2009

Study information

• Verified date: October 2012
• Source: Sangamo Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies

Intervention

Drug:
• SB-509
60 mg dose

Other:
• Normal Saline

Locations

Country	Name	City	State
Mexico	Instituto Mexicano de Investigación Clinica	Mexico City	Col. Roma
United States	Upstate Clinical Research	Albany	New York
United States	Bradenton Research Center	Bradenton	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Nerve and Muscle Center of Texas	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Coordinated Clinical Research	La Jolla	California
United States	Advanced Medical Research, LLC	Lakewood	California
United States	University of Miami, Diabetes Research Institute	Miami	Florida
United States	Peripheral Neuropathy Center, Weill Medical College of Cornell University	New York	New York
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	DGD Research	San Antonio	Texas
United States	SF Clinical Research Center	San Francisco	California
United States	Neurology Clinical Research	Sunrise	Florida
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Sangamo Biosciences	Juvenile Diabetes Research Foundation

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		One year	No
Secondary	Safety		One year	Yes

External Links

•   Sponsor website