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- Ensayo clínico NCT00963768
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus
22 de abril de 2014 actualizado por: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of JNJ-28431754 in Type 2 Diabetes Mellitus Patients
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie, blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of JNJ-28431754 compared to placebo in patients with Type 2 diabetes mellitus.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized (study drug assigned by chance), double-blind (neither physician, patient nor the sponsor knows the assigned treatment), placebo-controlled, single and multiple (14 days) ascending dose, parallel group study in 3 study centers (United States, Germany and South Korea).
Five cohorts (groups) of patients with Type 2 diabetes mellitus (T2DM) will be studied.
One dose level will be evaluated in each cohort.
Sixteen (16) patients will be randomly assigned to receive JNJ-28431754 and four (4) patients to receive matching placebo within each cohort.
The planned doses are 30, 100, 300 and 600 mg per day.
Twice-daily dosing may also be evaluated in one or more of the cohorts.
An additional cohort of Asian patients will also be evaluated at a dose level, which was previously tested in a prior cohort and considered to be well tolerated.
Blood and urine samples will be collected from patients during the study for pharmacokinetic and pharmacodynamic assessments.
The safety and tolerability of JNJ-28431754 will be monitored throughout the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
116
Fase
- Fase 1
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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Neuss, Alemania
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Seoul, Corea, república de
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California
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Chula Vista, California, 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
25 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients must have been diagnosed with Type 2 Diabetes for at least one year before screening
- Patients must be taking a stable dose of oral (by mouth) anti-diabetic monotherapy or a combination of two anti-diabetic medications
- Males or postmenopausal or surgically sterile women (post-menopausal is defined as no menses for at least 18 months prior to study start or no menses for 6 to 18 months)
- Body mass index (weight in kg/height in m2) should be between 20 to 39.9 kg/m2
Exclusion Criteria:
- History of Type 1, brittle diabetes or secondary forms of diabetes
- History of repeated severe hypoglycemic episodes
- History of diabetic complications including retinopathy, nephropathy, neuropathy, gastroparesis, or ketoacidosis
- History of, or currently active illness including but not limited to cardiovascular disease, hematological disease, respiratory disease, hepatic or gastrointestinal disease, endocrine/metabolic disorders, neurologic or psychiatric disease, or malignant neoplasms considered by the Investigator to be clinically significant
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cohort 1
JNJ-28431754 30 mg/day or placebo.
The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
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A liquid suspension of 30 mg, 100 mg, 300 mg of JNJ-28431754 taken once (or twice) daily or 600 mg taken once daily will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser for 14 days (Day 1 and Days 3 through 16).
Otros nombres:
A liquid suspension of placebo will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser once or twice daily for 14 days (Day 1 and Days 3 through 16).
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Experimental: Cohort 2
JNJ-28431754 100 mg/day or placebo.
The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
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A liquid suspension of 30 mg, 100 mg, 300 mg of JNJ-28431754 taken once (or twice) daily or 600 mg taken once daily will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser for 14 days (Day 1 and Days 3 through 16).
Otros nombres:
A liquid suspension of placebo will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser once or twice daily for 14 days (Day 1 and Days 3 through 16).
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Experimental: Cohort 3
JNJ-28431754 300 mg/day or placebo.
The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
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A liquid suspension of 30 mg, 100 mg, 300 mg of JNJ-28431754 taken once (or twice) daily or 600 mg taken once daily will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser for 14 days (Day 1 and Days 3 through 16).
Otros nombres:
A liquid suspension of placebo will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser once or twice daily for 14 days (Day 1 and Days 3 through 16).
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Experimental: Cohort 4
JNJ-28431754 600 mg/day or placebo.
The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.
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A liquid suspension of 30 mg, 100 mg, 300 mg of JNJ-28431754 taken once (or twice) daily or 600 mg taken once daily will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser for 14 days (Day 1 and Days 3 through 16).
Otros nombres:
A liquid suspension of placebo will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser once or twice daily for 14 days (Day 1 and Days 3 through 16).
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Experimental: Cohort 5
JNJ-28431754 at 30 mg/day, 100 mg/day, or 300 mg/day or placebo (the dose level to be determined from the prior cohort of patients tested and considered to be well tolerated).
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A liquid suspension of 30 mg, 100 mg, 300 mg of JNJ-28431754 taken once (or twice) daily or 600 mg taken once daily will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser for 14 days (Day 1 and Days 3 through 16).
Otros nombres:
A liquid suspension of placebo will be administered by study personnel directly into the patient's mouth using an oral liquid dispenser once or twice daily for 14 days (Day 1 and Days 3 through 16).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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The number of patients with adverse events as a measure of safety and tolerability
Periodo de tiempo: Up to 34 days (baseline [Day -1] through follow up [10 days following Day 22 visit])
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Up to 34 days (baseline [Day -1] through follow up [10 days following Day 22 visit])
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Change from baseline (Day -1) for mean 24-hour plasma glucose concentration
Periodo de tiempo: Day -1 through Day 16
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Day -1 through Day 16
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Change from baseline 24-hour urinary glucose excretion (UGE)
Periodo de tiempo: Day -1 through 16
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Day -1 through 16
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Change from baseline mean fasting plasma glucose
Periodo de tiempo: Day -1 through Day 16
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Day -1 through Day 16
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Change from baseline mean morning fasting body weight
Periodo de tiempo: Day -1 through 20
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Day -1 through 20
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Renal glucose threshold
Periodo de tiempo: Day -1 through Day 16
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Day -1 through Day 16
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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.
Publicaciones Generales
- Sha S, Devineni D, Ghosh A, Polidori D, Hompesch M, Arnolds S, Morrow L, Spitzer H, Demarest K, Rothenberg P. Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes. PLoS One. 2014 Sep 30;9(9):e110069. doi: 10.1371/journal.pone.0110069. eCollection 2014.
- Sha S, Devineni D, Ghosh A, Polidori D, Hompesch M, Arnolds S, Morrow L, Spitzer H, Demarest K, Rothenberg P. Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes. PLoS One. 2014 Aug 28;9(8):e105638. doi: 10.1371/journal.pone.0105638. eCollection 2014. Erratum In: PLoS One. 2014 Sep 30;9(9):e110069.
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 junio de 2007
Finalización primaria (Actual)
1 de diciembre de 2007
Finalización del estudio (Actual)
1 de diciembre de 2007
Fechas de registro del estudio
Enviado por primera vez
20 de agosto de 2009
Primero enviado que cumplió con los criterios de control de calidad
21 de agosto de 2009
Publicado por primera vez (Estimar)
24 de agosto de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
23 de abril de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2014
Última verificación
1 de abril de 2014
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
- Diabetes Mellitus, Tipo 2
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores del transportador de sodio-glucosa 2
- Canagliflozina
Otros números de identificación del estudio
- CR012451
- 28431754NAP1002 (Otro identificador: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
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. .
Ensayos clínicos sobre Diabetes Mellitus, Tipo 2
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Diabetes Foundation, IndiaIndian Council of Medical ResearchTerminadoDM2 (Diabetes Mellitus Tipo 2) | NormoglucemiaIndia
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Daewoong Pharmaceutical Co. LTD.TerminadoDM2 (Diabetes Mellitus Tipo 2)Corea, república de
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Daewoong Pharmaceutical Co. LTD.TerminadoDM2 (Diabetes Mellitus Tipo 2)Corea, república de
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Scripps Whittier Diabetes InstituteSan Diego State UniversityTerminadoDiabetes mellitus tipo 2 (DM2)Estados Unidos
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Novartis PharmaceuticalsTerminadoDiabetes mellitus tipo 2 (DM2)Estados Unidos
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Merck Sharp & Dohme LLCTerminadoDiabetes mellitus tipo 2 (DM2)
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AstraZenecaBristol-Myers SquibbTerminadoDiabetes mellitus tipo 2 (DM2)Estados Unidos
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Novartis PharmaceuticalsTerminadoDiabetes mellitus tipo 2 (DM2)Japón
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PegBio Co., Ltd.ReclutamientoDiabetes mellitus tipo 2 (DM2)Porcelana, Taiwán, Hong Kong
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Daewoong Pharmaceutical Co. LTD.TerminadoDM2 (Diabetes Mellitus Tipo 2)Corea, república de
Ensayos clínicos sobre JNJ 28431754
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Janssen Research & Development, LLCThe George Institute for Global Health, AustraliaTerminadoEnfermedades cardiovasculares | Diabetes Mellitus, Tipo 2 | Factores de riesgoEstados Unidos, Australia, Polonia, Ucrania, Reino Unido, Bélgica, Alemania, Francia, España, Argentina, Colombia, Israel, México, India, Canadá, Países Bajos, Suecia, Malasia, Nueva Zelanda, Estonia, Federación Rusa, Hungría, Noruega, L... y más
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