An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
18 de julio de 2006 actualizado por: Eli Lilly and Company
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos
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Huntsville, Alabama, Estados Unidos
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Arizona
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Peoria, Arizona, Estados Unidos
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Tucson, Arizona, Estados Unidos
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Arkansas
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Little Rock, Arkansas, Estados Unidos
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California
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Bakersfield, California, Estados Unidos
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Pico Rivera, California, Estados Unidos
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San Diego, California, Estados Unidos
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Santa Ana, California, Estados Unidos
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Colorado
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Denver, Colorado, Estados Unidos
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Connecticut
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Waterbury, Connecticut, Estados Unidos
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West Hartford, Connecticut, Estados Unidos
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Florida
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Clearwater, Florida, Estados Unidos
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Kissimmee, Florida, Estados Unidos
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Ocala, Florida, Estados Unidos
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St Petersburg, Florida, Estados Unidos
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Georgia
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Decatur, Georgia, Estados Unidos
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Hawaii
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Honolulu, Hawaii, Estados Unidos
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Illinois
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Orland Park, Illinois, Estados Unidos
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Peoria, Illinois, Estados Unidos
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Indiana
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Evansville, Indiana, Estados Unidos
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Kansas
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Wichita, Kansas, Estados Unidos
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Kentucky
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Louisville, Kentucky, Estados Unidos
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Maryland
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Baltimore, Maryland, Estados Unidos
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Minnesota
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Edina, Minnesota, Estados Unidos
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Minneapolis, Minnesota, Estados Unidos
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New York
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Endwell, New York, Estados Unidos
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Great Neck, New York, Estados Unidos
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North Carolina
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Charlotte, North Carolina, Estados Unidos
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Fayetteville, North Carolina, Estados Unidos
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos
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Oregon
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Eugene, Oregon, Estados Unidos
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos
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Fleetwood, Pennsylvania, Estados Unidos
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Lansdale, Pennsylvania, Estados Unidos
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Philadelphia, Pennsylvania, Estados Unidos
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South Carolina
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MT Pleasant, South Carolina, Estados Unidos
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Texas
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San Antonio, Texas, Estados Unidos
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Utah
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Salt Lake City, Utah, Estados Unidos
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Virginia
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Lebanon, Virginia, Estados Unidos
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Washington
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Renton, Washington, Estados Unidos
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Spokane, Washington, Estados Unidos
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of Type 2 Diabetes for at least 3 months.
- Diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise.
- Diabetes therapy must be unchanged for at least 3 months prior to screening.
- Females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). Female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by FSH greater that 30ng/mL at screening.
Exclusion Criteria:
- Current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin.
- Current use of metformin or a sulfonylurea agent in combination.
- History of liver disease.
- History of unstable angina (as defined by the Braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months.
- Currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2003
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2003
Publicado por primera vez (Estimar)
22 de julio de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de julio de 2006
Última actualización enviada que cumplió con los criterios de control de calidad
18 de julio de 2006
Última verificación
1 de julio de 2006
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 5837
- H7R-MC-GCBD
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .