Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
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 |
The purpose of the study is to study the clinical effects of the investigational drug, SB-509 versus placebo in patients with diabetic neuropathy.
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Sangamo Biosciences | Juvenile Diabetes Research Foundation |
United States, Mexico,
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 |
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