- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01469065
A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes
26 de septiembre de 2013 actualizado por: Pfizer
A 2-week, Phase 1, Placebo-Controlled, Parallel Group Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Oral Doses Of PF-04991532 Given As Monotherapy To Adult Patients With Type 2 Diabetes Mellitus
This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2 diabetes.
Safety, pharmacokinetics (how the drug is distributed in the body), and pharmacodynamics (how the drug works in the body) will be studied.
Patients may be asked to wash off their diabetes medication for 4-6 prior to study drug administration, and they will remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of dosing, and some follow up tests.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
82
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
-
-
California
-
Chula Vista, California, Estados Unidos, 91911
- Pfizer Investigational Site
-
-
Florida
-
Miami, Florida, Estados Unidos, 33169
- Pfizer Investigational Site
-
-
-
-
Tokyo
-
Hachioji-shi, Tokyo, Japón
- Pfizer Investigational Site
-
-
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:
- Patients with type 2 diabetes mellitus who are taking either no medication for the treatment of diabetes (diet/exercise therapy only), or who are taking only a single oral anti-diabetic drug (OAD) that can be temporarily discontinued for approximately 8-10 weeks. For those taking a single OAD, treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 3 months prior to Screening. OAD medications that are acceptable to be discontinued include: a sulfonylurea (SU), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase 4 inhibitor (DPP-4i), or an alpha glucosidase inhibitor.
- Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).
- HbA1c >/=7% and </=10% if the patient is on diet/exercise therapy only and does not require any OAD discontinuation. HbA1c >/=6.5% and </=9% if the patient requires to be washed off an OAD.
Exclusion Criteria:
- Evidence or history of diabetic complications with significant end organ damage.
- History of stroke or transient ischemic attack.
- History of myocardial infarction.
- History of coronary artery bypass graft or stent implantation.
- Clinically significant peripheral vascular disease.
- Any history or clinical evidence of congestive heart failure, NYHA Classes II IV.
- Current history of angina/unstable angina.
- One or more episodes of hypoglycemia within the last 3 months, or two or more episodes of hypoglycemia within the last 6 months.
- A positive urine drug screen.
- Use of tobacco or nicotine-containing products in excess of the equivalent of 10 cigarettes per day.
- Blood pressure >/=160 mm Hg (systolic) or >/=100 mm Hg (diastolic), following at least 5 minutes of rest.
- Pregnant or nursing females; females of childbearing potential.
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: PF-04991532
PF-04991532 experimental study medication
|
Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days
Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days
Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days
Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days
|
Comparador de placebos: Placebo
PF-04991532 Matching Placebo
|
Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline (Day -1) in Mean Daily Glucose at Day 14
Periodo de tiempo: Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dose
|
Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.
|
Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dose
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of PF-04991532
Periodo de tiempo: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14
|
Area under the plasma concentration versus time curve (AUC) from time zero to 24 hours post morning dose
|
0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14
|
Area Under the Curve From Time Zero to 10 Hours Postdose (AUC10) of PF-04991532
Periodo de tiempo: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
Area under the plasma concentration versus time curve (AUC) from time zero to 10 hours post morning dose.
|
0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Cmax(AM))
Periodo de tiempo: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning
|
0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning
|
|
Maximum Observed Plasma Concentration of PF-04991532 After Evening Dose Administration (Cmax(PM))
Periodo de tiempo: 10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14
|
10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14
|
|
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04991532
Periodo de tiempo: Day 14
|
Day 14
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Morning Dose Administration (Tmax(AM))
Periodo de tiempo: 0 (predose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
0 (predose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Evening Dose Administration (Tmax(PM))
Periodo de tiempo: 10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14
|
Time was computed as post morning dose.
|
10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14
|
Apparent Oral Clearance (CL/F) of PF-04991532
Periodo de tiempo: Day 1 and Day 14: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10 (before evening dose), 10.5, 11, 12, 13, 15, 18 and 24 hours after morning dose
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
|
Day 1 and Day 14: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10 (before evening dose), 10.5, 11, 12, 13, 15, 18 and 24 hours after morning dose
|
Observed Accumulation Ratio of Area Under the Curve From Time Zero to 10 Hours Postdose of PF-04991532 (Rac)
Periodo de tiempo: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
Area under the curve from time zero to 10 hours postdose of PF-04991532 (AUC10) of Day 14 divided by AUC10 of Day 1
|
0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
Observed Accumulation Ratio of Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Rac, Cmax(AM))
Periodo de tiempo: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
Maximum observed plasma concentration of PF-04991532 after morning dose administration (Cmax(AM)) of Day 14 divided by Cmax(AM) of Day 1
|
0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
Dose Normalized Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24(dn)) of PF-04991532
Periodo de tiempo: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14
|
Area under the curve from time zero to 24 Hours Postdose (AUC24) divided by total daily dose
|
0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14
|
Dose Normalized Maximum Plasma Concentration After Morning Dose Administration (Cmax(AM)(dn)) of PF-04991532
Periodo de tiempo: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
Maximum Observed Plasma Concentration of PF-04991532 after Morning Dose Administration (Cmax(AM)) divided by dose
|
0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14
|
Change From Baseline (Day -2) in Mean Daily Glucose at Day 13
Periodo de tiempo: Baseline: hours -72, -70, -68, -66, -62, -60, -57, and -54 on Day -2 (Day 1 morning dose was hour 0); Day 13: 0 (before morning dose), 2, 4, 6, 10, 12, 15 and 18 hours after Day 13 morning dose
|
Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day.
|
Baseline: hours -72, -70, -68, -66, -62, -60, -57, and -54 on Day -2 (Day 1 morning dose was hour 0); Day 13: 0 (before morning dose), 2, 4, 6, 10, 12, 15 and 18 hours after Day 13 morning dose
|
Change From Baseline in Area Under the Curve of Glucose From Time 2 to 6 Hours Post Morning Dose (Glucose AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14
Periodo de tiempo: Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose
|
Area under the curve of glucose from time 2 to 6 hours post morning dose (Glucose AUC(2-6)) was calculated based on 8 glucose measurements at prespecified time points using the linear trapezoidal method.
Nominal times were used in the calculation.
Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).
|
Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Periodo de tiempo: Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 (before morning dose) on Day 1; hour 0 (before morning dose of each day) on Days 1, 2, 3, 6, and 10; and 24 hours after Day 14 morning dose on Day 15
|
The average of the Day -1 (hour -48), Day 0 (hour -24) and Day 1 pre-dose (hour 0) measurements was the baseline for fasting plasma glucose (FPG) analyses.
|
Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 (before morning dose) on Day 1; hour 0 (before morning dose of each day) on Days 1, 2, 3, 6, and 10; and 24 hours after Day 14 morning dose on Day 15
|
Change From Baseline in Area Under the Curve of Insulin From Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14
Periodo de tiempo: Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose
|
Area Under the Curve of Insulin from Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) was calculated based on 8 insulin measurements at prespecified time points using the linear trapezoidal method.
Nominal times were used in the calculation.
Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).
|
Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose
|
Change From Baseline in Area Under the Curve of C-peptide From Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14
Periodo de tiempo: Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose
|
Area Under the Curve of C-peptide from Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) was calculated based on 8 C-peptide measurements at prespecified timepoints using the linear trapezoidal method.
Nominal times were used in the calculation.
Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).
|
Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose
|
Change From Baseline in Fasting Lipid Parameters at Day 14 and 16
Periodo de tiempo: Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 on Day 1 for TG and Hour 0 (before morning dose) on Day 1 for TC, HDL, and LDL; 48 hours after morning dose on Day 16 for TG and Hour 0 (before morning dose) on Day14 for TC, HDL, and LDL
|
Baseline for fasting triglycerides (TG) was defined as the average of the Day -1 (hour -48), Day 0 (hour -24), and Day 1 pre-dose (hour 0) measurements.
Baseline for fasting total cholesterol (TC), cholesterol (high-density lipoprotein (HDL)), and cholesterol (low-density lipoprotein (LDL)) was defined as the Day 1 pre-dose (hour 0) measurement.
|
Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 on Day 1 for TG and Hour 0 (before morning dose) on Day 1 for TC, HDL, and LDL; 48 hours after morning dose on Day 16 for TG and Hour 0 (before morning dose) on Day14 for TC, HDL, and LDL
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 diciembre de 2011
Finalización primaria (Actual)
1 de mayo de 2012
Finalización del estudio (Actual)
1 de mayo de 2012
Fechas de registro del estudio
Enviado por primera vez
25 de octubre de 2011
Primero enviado que cumplió con los criterios de control de calidad
7 de noviembre de 2011
Publicado por primera vez (Estimar)
10 de noviembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de octubre de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
26 de septiembre de 2013
Última verificación
1 de septiembre de 2013
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
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Micronutrientes
- Vitaminas
- Complejo de vitamina B
- Ácidos nicotínicos
- Ácido 6-(3-ciclopentil-2-(4-(trifluorometil)-1H-imidazol-1-il)propanamido)nicotínico
Otros números de identificación del estudio
- B2611005
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
-
AstraZenecaReclutamiento
-
Daewoong Pharmaceutical Co. LTD.Aún no reclutandoDM2 (Diabetes Mellitus Tipo 2)
-
University of ZambiaUniversity Teaching Hospital, Lusaka, ZambiaAún no reclutandoDiabetes Mellitus Tipo 2 Sin Complicaciones
-
Zhongda HospitalReclutamientoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Newsoara Biopharma Co., Ltd.ReclutamientoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
Shanghai Golden Leaf MedTec Co. LtdActivo, no reclutandoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Haisco Pharmaceutical Group Co., Ltd.TerminadoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
PegBio Co., Ltd.TerminadoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Oramed, Ltd.IntegriumTerminadoDM2 (Diabetes Mellitus Tipo 2)Estados Unidos
Ensayos clínicos sobre PF-04991532
-
Danish Head and Neck Cancer GroupReclutamientoHipoxia | Carcinoma de células escamosas de cabeza y cuello | Radioterapia | Modificación hipóxica | Perfil genético, firma genéticaDinamarca
-
PfizerTerminadoDiabetes Mellitus, Tipo 2Estados Unidos, Taiwán, Eslovaquia, México, Canadá, Hungría
-
PfizerTerminadoSaludable | La interacción de drogasBélgica
-
PfizerTerminadoTrastornos del metabolismo de la glucosa | Diabetes Mellitus, Tipo 2 | Diabetes mellitusEstados Unidos
-
PfizerTerminadoTrastornos del metabolismo de la glucosa | Diabetes Mellitus, Tipo 2 | Diabetes mellitusEstados Unidos
-
PfizerTerminado
-
PfizerTerminado
-
University of FloridaTerminadoSíntomas gastrointestinales | Frecuencia de heces | Tiempo de tránsito gastrointestinalEstados Unidos
-
PfizerTerminado