- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00375492
Effect on Weight Loss of Exenatide Versus Placebo
19 de marzo de 2015 actualizado por: AstraZeneca
Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program
This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss.
This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea.
Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
196
Fase
- Fase 3
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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Arizona
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Peoria, Arizona, Estados Unidos
- Research Site
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Florida
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Jacksonville, Florida, Estados Unidos
- Research Site
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Orlando, Florida, Estados Unidos
- Research Site
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Indiana
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Indianapolis, Indiana, Estados Unidos
- Research Site
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Massachusetts
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Boston, Massachusetts, Estados Unidos
- Research Site
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Minnesota
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Minneapolis, Minnesota, Estados Unidos
- Research Site
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Missouri
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St. Louis, Missouri, Estados Unidos
- Research Site
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South Carolina
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Spartanburg, South Carolina, Estados Unidos
- Research Site
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Texas
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San Antonio, Texas, Estados Unidos
- Research Site
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Washington
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Renton, Washington, Estados Unidos
- Research Site
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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 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosed with type 2 diabetes for at least 6 months
- Have been treated with a stable dose of the following for at least 6 weeks prior to screening: *immediate or extended release metformin, or *a sulfonylurea, or *a fixed-dose sulfonylurea/metformin combination therapy
- Have an HbA1c of 6.6% to 10.0%, inclusive
- Have a Body Mass Index (BMI) of 25 kg/m^2 to 39.9 kg/m^2, inclusive
Exclusion Criteria:
- Are treated with any of the following excluded medications: *exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; *Symlin injection at any time; * Byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; *drugs that directly affect gastrointestinal motility; *use of a weight loss drug (including those available over the counter) within 3 months of screening; *chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening
- Have conditions contraindicating metformin and/or sulfonylurea use
- Have had a change in lipid-lowering agents within 6 weeks of screening
- Have received glucagon-like peptide-1 (GLP-1) analogs, or dipeptidyl peptidase-IV inhibitors (DPP-IV inhibitors) or have previously participated in this study
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
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
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Grupo A
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inyección subcutánea, 5 mcg o 10 mcg, dos veces al día
Otros nombres:
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Comparador de placebos: Grupo B
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subcutaneous injection, volume equivalent to exenatide dose, twice a day
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Body Weight
Periodo de tiempo: Baseline, Week 24
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Change in body weight from baseline (Week 0) after 24 weeks of treatment (i.e., weight at week 24 minus weight at week 0).
Body weight measured in kilograms (k).
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Baseline, Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Periodo de tiempo: baseline, Week 24
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Change in HbA1c from baseline (Week 0) after 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0).
HbA1c is measured as percent (%) of hemoglobin.
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baseline, Week 24
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Change From Baseline in 6-point Self Monitored Blood Glucose (SMBG) Profile at Week 24
Periodo de tiempo: baseline, Week 24
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Change in SMBG at each of 6 time points throughout a day (blood glucose measurements before and 2 hours after the start of the morning, mid-day, and evening meals); week 24 compared to week 0 (i.e., SMBG at week 24 minus SMBG at week 0).
Fasting Glucose measured in millimoles per liter (mmol/L).
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baseline, Week 24
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Change From Baseline in Waist Circumference at Week 24
Periodo de tiempo: baseline, Week 24
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Change in waist circumference from baseline after 24 weeks of treatment (i.e., waist circumference at week 24 minus waist circumference at week 0).
Waist measured in centimeters (cm).
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baseline, Week 24
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Ratio of Homeostatic Model Assessment-Beta Cell (HOMA-B) at Week 24 to HOMA-B at Baseline
Periodo de tiempo: baseline, Week 24
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Ratio of HOMA-B at Week 24 to HOMA-B at baseline (Week 0).
HOMA-B is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees beta-cell deficiency.
HOMA-B allows a quantitative assessment of the contributions of deficient beta cell function to the fasting hyperglycemia.
HOMA-B is measured as a percent of the normal population (normal beta cell function = 100%, which is used as a reference in the calculation).
The higher the percent the better for the participant.
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baseline, Week 24
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Ratio of Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) at Week 24 to HOMA-S at Baseline
Periodo de tiempo: baseline, Week 24
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Ratio of HOMA-S at Week 24 to HOMA-S at baseline, week 0. HOMA-S is a computer solved model used to predict the homeostatic concentrations which arise from varying degrees of insulin sensitivity.
HOMA-S allows a quantitative assessment of the contributions of insulin sensitivity to the fasting hyperglycemia.
HOMA-S is measured as a percent of the normal population (normal insulin sensitivity = 100%, which is used as a reference in the calculation).
The higher the percent the better for the participant.
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baseline, Week 24
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Change From Baseline in High Density Lipoprotein (HDL) Cholesterol at Week 24
Periodo de tiempo: baseline, Week 24
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Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0).
HDL measured as mmol/L.
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baseline, Week 24
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Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Week 24
Periodo de tiempo: baseline, Week 24
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Change in LDL cholesterol from baseline (Week 0) after 24 weeks of treatment (ie., LDL cholesterol at week 24 minus LDL cholesterol at week 0).
LDL cholesterol measured in mmol/L
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baseline, Week 24
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Change From Baseline in Total Cholesterol at Week 24
Periodo de tiempo: baseline, week 24
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Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0).
Total cholesterol measured in mmol/L.
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baseline, week 24
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Ratio of Triglycerides at Week 24 to Triglycerides at Baseline
Periodo de tiempo: baseline, Week 24
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Ratio of triglyceride levels at Week 24 to triglyceride levels at baseline, Week 0 (ie., triglycerides at Week 24 divided by triglycerides at baseline, Week 0).
Triglycerides measured in mmol/L.
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baseline, Week 24
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Number of Participants With Hypoglycemic Events During the Study
Periodo de tiempo: Baseline to 24 weeks
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Number of participants experiencing one or more events of hypoglycemia at any point in the study
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Baseline to 24 weeks
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Rate of Hypoglycemic Events
Periodo de tiempo: 24 weeks
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Overall rate of hypoglycemia, adjusted for 1 year (ie., events of hypoglycemia per participant per year).
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24 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: James Malone, MD, Eli Lilly and Company
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 importantes del estudio
Inicio del estudio
1 de septiembre de 2006
Finalización primaria (Actual)
1 de febrero de 2008
Finalización del estudio (Actual)
1 de febrero de 2008
Fechas de registro del estudio
Enviado por primera vez
11 de septiembre de 2006
Primero enviado que cumplió con los criterios de control de calidad
11 de septiembre de 2006
Publicado por primera vez (Estimar)
13 de septiembre de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de abril de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
19 de marzo de 2015
Última verificación
1 de marzo de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Peso corporal
- Cambios en el peso corporal
- Diabetes Mellitus, Tipo 2
- Pérdida de peso
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes contra la obesidad
- Incretinas
- Exenatida
Otros números de identificación del estudio
- H8O-US-GWBM
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. .
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