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- Klinische proef NCT00406458
Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Col. Roma
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Mexico City, Col. Roma, Mexico, 06700
- Instituto Mexicano de Investigación Clinica
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California
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La Jolla, California, Verenigde Staten, 92037
- Coordinated Clinical Research
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Lakewood, California, Verenigde Staten, 90712
- Advanced Medical Research, LLC
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San Francisco, California, Verenigde Staten, 94109
- SF Clinical Research Center
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Walnut Creek, California, Verenigde Staten, 94598
- Diablo Clinical Research
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Florida
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Bradenton, Florida, Verenigde Staten, 34205
- Bradenton Research Center
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Miami, Florida, Verenigde Staten, 33136
- University of Miami, Diabetes Research Institute
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Sunrise, Florida, Verenigde Staten, 33351
- Neurology Clinical Research
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- University of Kansas Medical Center
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68131
- Creighton Diabetes Center
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New York
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Albany, New York, Verenigde Staten, 12205
- Upstate Clinical Research
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New York, New York, Verenigde Staten, 10022
- Peripheral Neuropathy Center, Weill Medical College of Cornell University
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Pennsylvania
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Duncansville, Pennsylvania, Verenigde Staten, 16635
- Altoona Center for Clinical Research
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Texas
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Houston, Texas, Verenigde Staten, 77030
- Nerve and Muscle Center of Texas
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San Antonio, Texas, Verenigde Staten, 78229
- DGD Research
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: SB-509
60 mg SB-509 injected IM into lower limbs every 2 months
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60 mg dose
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Placebo-vergelijker: Normal Saline
Normal saline injected IM into lower limbs every 2 months
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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)
Tijdsspanne: One year
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One year
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Veiligheid
Tijdsspanne: Een jaar
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Een jaar
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Glucosemetabolismestoornissen
- Metabole ziekten
- Ziekten van het zenuwstelsel
- Ziekten van het immuunsysteem
- Auto-immuunziekten
- Endocriene systeemziekten
- Diabetes complicaties
- Neuromusculaire aandoeningen
- Ziekten van het perifere zenuwstelsel
- Suikerziekte
- Diabetes mellitus, type 2
- Diabetes mellitus, type 1
- Polyneuropathieën
- Diabetische neuropathieën
Andere studie-ID-nummers
- SB-509-0601
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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