A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus
17 de octubre de 2013 actualizado por: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Randomized, Placebo- and Active Comparator-Controlled, 4-Week Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of JNJ-41443532 in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication) and pharmacodynamics (what the medication does to the body) of treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus participants.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized (the study medication is assigned by chance), double-blind (neither investigator nor participant knows the treatment that the participant receives), multicenter (study conducted at multiple sites), and placebo (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) and active comparator (an established effective treatment that is compared with a medication to test whether the medication has a real effect in a clinical study) controlled study (placebo or active comparator is compared with the study medication to test whether the study medication has a real effect in clinical study).
The study consists of 4 phases: screening phase (45 days before administration of study medication); pre-dosing run-in phase (a phase before a clinical study is commenced when no treatment is given.
In this study, participant's glucose level will be observed during run-in-phase: days 15 to 1 before administration of study medication); treatment phase, and follow-up phase (7 to 10 days after the last dose of the study medication).
Approximately 88 participants will be enrolled in this study.
All participants will be randomly assigned to 4 treatment arms: JNJ-41443532 250 mg; JNJ-41443532 1000 mg; pioglitazone arm; and placebo.
Safety evaluations will include assessment of adverse events including ocular assessments, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study.
The maximum study duration for each participant will be approximately 12 weeks.
Tipo de estudio
Intervencionista
Inscripción (Actual)
89
Fase
- Fase 2
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:
- Diagnosed Type 2 Diabetes Mellitus (T2DM) for at least 3 months prior screening
- On a stable treatment regimen for at least 2 months prior screening
- Medically stable on the basis of physical examination, medical history, and clinical laboratory tests performed at screening and 2 days before administration of the study medication
- Fasting plasma glucose (FPG) concentrations between 140 mg/dL and 270 mg/dL on 2 days before administration of the study medication
- Agrees to protocol-defined use of effective contraception
Exclusion Criteria:
- History of other types of diabetes and complications or secondary forms of diabetes
- History of eating disorder or recent significant changes in body weight (ie, more or equal to 5 percent over 3 months prior to screening) due to dieting or nutritional treatments
- Taking antihyperglycemic agents (insulin, exenatide, and liraglutide) within 6 months or thiazolidinedione within 3 months of 2 days before administration of the study medication
- Clinically significant abnormal electrocardiogram
- History of, or currently active, significant illness or medical disorders, retinal disease, tuberculosis
- Clinically important serious infection, positive for serology at screening (hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies)
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: JNJ-41443532 250 mg
Participants will receive JNJ-41443532 250 mg in morning and evening for 28 days.
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Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.
Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
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Experimental: JNJ-41443532 1000 mg
Participants will receive JNJ-41443532 1000 mg (4 X 250 mg) in morning and evening for 28 days.
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Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.
Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
|
|
Comparador activo: Pioglitazone
Participants will receive pioglitazone 30 mg in morning for 28 days.
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Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days.
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Comparador de placebos: Placebo
Participants will receive matching placebo for JNJ-41443532 and pioglitazone for 28 days.
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Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)
Periodo de tiempo: From baseline (Day -1) to Day 28
|
Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.
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From baseline (Day -1) to Day 28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)
Periodo de tiempo: From baseline to Day 28
|
Difference is calculated as the change in FPG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
|
From baseline to Day 28
|
|
Change From Baseline to Day 28 in Insulin Secretion
Periodo de tiempo: From baseline to Day 28
|
Difference is calculated as the change in insulin secretion in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
Insulin secretion is measured by the absolute change in Homeostasis Model Assessment of steady state islet beta cell (HOMA-%B).
HOMA-%B calculated as: (360 multiplied by Insulin [pmol/L]) divided by ([Glucose {mg/dL} minus 63] multiplied by 6.945).
Higher value is better (signifies improvement relative to baseline).
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From baseline to Day 28
|
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Change From Baseline to Day 28 in Insulin Resistance
Periodo de tiempo: From baseline to Day 28
|
Difference is calculated as the change in insulin resistance in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
Insuline sensitivity is measured by absolute change in Homeostasis Model Assessment of insulin resistance (HOMA-IR).
Insulin sensitivity is HOMA-%S and HOMA-IR is the reciprocal of HOMA-%S.
HOMA-IR calculated as: (Glucose [mg/dL]) multiplied by Insulin [pmol/L]) divided by (405 multiplied by 6.945).
Lower value is better (signifies improvement relative to baseline).
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From baseline to Day 28
|
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Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6)
Periodo de tiempo: From baseline to Day 28
|
Difference is calculated as the geometric mean change in IL-6 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change.
IL-6 is a systemic inflammatory markers and is an independent predictors of insulin resistance and progression to type 2 diabetes mellitus.
IL-6 was not measured for pioglitazone guoup.
The unit of IL-6 is picograms per milliliter (pg/mL).
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From baseline to Day 28
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Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18)
Periodo de tiempo: From baseline to Day 28
|
Difference is calculated as the geometric mean change in IL-18 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change.
IL-18 was not measured for pioglitazone group.
The unit of IL-18 is picograms per milliliter (pg/mL)
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From baseline to Day 28
|
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Change From Baseline to Day 28 in Systemic Levels of C-Reactive Protein (CRP)
Periodo de tiempo: From baseline to Day 28
|
Difference is calculated as the geometric mean change in CRP from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change.
CRP was not measured for pioglitazone group.
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From baseline to Day 28
|
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Change From Baseline to Day 29 in Body Weight
Periodo de tiempo: From baseline to Day 29
|
Difference is calculated as the change in body weight in Least Square Mean (LSM) from baseline to Day 29 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
|
From baseline to Day 29
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este 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 2010
Finalización primaria (Actual)
1 de junio de 2011
Finalización del estudio (Actual)
1 de junio de 2011
Fechas de registro del estudio
Enviado por primera vez
22 de octubre de 2010
Primero enviado que cumplió con los criterios de control de calidad
28 de octubre de 2010
Publicado por primera vez (Estimar)
29 de octubre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de diciembre de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
17 de octubre de 2013
Última verificación
1 de octubre de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR017401
- 41443532EDI2001 (Otro identificador: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
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