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Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

15 de mayo de 2014 actualizado por: Boehringer Ingelheim

Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive

to determine safety, efficacy and tolerability of BI 1356 versus placebo

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

133

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

  • Australia
      • Adelaide, SA, Australia
        • 1218.43.61005 Boehringer Ingelheim Investigational Site
      • Herston, QLD, Australia
        • 1218.43.61002 Boehringer Ingelheim Investigational Site
    • New South Wales
      • Gosford, New South Wales, Australia
        • 1218.43.61009 Boehringer Ingelheim Investigational Site
    • Queensland
      • Auchenflower, Queensland, Australia
        • 1218.43.61010 Boehringer Ingelheim Investigational Site
      • Kippa Ring, Queensland, Australia
        • 1218.43.61006 Boehringer Ingelheim Investigational Site
    • Victoria
      • Reservoir, Victoria, Australia
        • 1218.43.61007 Boehringer Ingelheim Investigational Site
      • Richmond, Victoria, Australia
        • 1218.43.61011 Boehringer Ingelheim Investigational Site
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos
        • 1218.43.10027 Boehringer Ingelheim Investigational Site
    • California
      • Chula Vista, California, Estados Unidos
        • 1218.43.10011 Boehringer Ingelheim Investigational Site
      • Riverside, California, Estados Unidos
        • 1218.43.10006 Boehringer Ingelheim Investigational Site
      • Whittier, California, Estados Unidos
        • 1218.43.10021 Boehringer Ingelheim Investigational Site
    • Florida
      • Pembroke Pines, Florida, Estados Unidos
        • 1218.43.10013 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, Estados Unidos
        • 1218.43.10009 Boehringer Ingelheim Investigational Site
    • Georgia
      • Decatur, Georgia, Estados Unidos
        • 1218.43.10018 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, Estados Unidos
        • 1218.43.10022 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, Estados Unidos
        • 1218.43.10015 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City, Missouri, Estados Unidos
        • 1218.43.10016 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, Estados Unidos
        • 1218.43.10004 Boehringer Ingelheim Investigational Site
      • Great Neck, New York, Estados Unidos
        • 1218.43.10003 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos
        • 1218.43.10020 Boehringer Ingelheim Investigational Site
    • Ohio
      • Delaware, Ohio, Estados Unidos
        • 1218.43.10019 Boehringer Ingelheim Investigational Site
      • Mentor, Ohio, Estados Unidos
        • 1218.43.10008 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, Estados Unidos
        • 1218.43.10005 Boehringer Ingelheim Investigational Site
      • Carlisle, Pennsylvania, Estados Unidos
        • 1218.43.10007 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos
        • 1218.43.10001 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Aiken, South Carolina, Estados Unidos
        • 1218.43.10025 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, Estados Unidos
        • 1218.43.10023 Boehringer Ingelheim Investigational Site
      • Austin, Texas, Estados Unidos
        • 1218.43.10024 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Estados Unidos
        • 1218.43.10014 Boehringer Ingelheim Investigational Site
      • Lufkin, Texas, Estados Unidos
        • 1218.43.10017 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, Estados Unidos
        • 1218.43.10010 Boehringer Ingelheim Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • 1218.43.85201 Boehringer Ingelheim Investigational Site
      • New Territories, Hong Kong
        • 1218.43.85203 Boehringer Ingelheim Investigational Site
  • Israel
      • Afula, Israel
        • 1218.43.97008 Boehringer Ingelheim Investigational Site
      • Ashkelon, Israel
        • 1218.43.97005 Boehringer Ingelheim Investigational Site
      • Haifa, Israel
        • 1218.43.97003 Boehringer Ingelheim Investigational Site
      • Jerusalem, Israel
        • 1218.43.97004 Boehringer Ingelheim Investigational Site
      • Jerusalem, Israel
        • 1218.43.97009 Boehringer Ingelheim Investigational Site
      • Kfar Saba, Israel
        • 1218.43.97002 Boehringer Ingelheim Investigational Site
      • Nahariya, Israel
        • 1218.43.97007 Boehringer Ingelheim Investigational Site
      • Safed, Israel
        • 1218.43.97001 Boehringer Ingelheim Investigational Site
      • Tel Aviv, Israel
        • 1218.43.97006 Boehringer Ingelheim Investigational Site
  • Nueva Zelanda
      • Auckland, Nueva Zelanda
        • 1218.43.64001 Boehringer Ingelheim Investigational Site
      • Christchurch, Nueva Zelanda
        • 1218.43.64003 Boehringer Ingelheim Investigational Site
      • Takpuna, Nueva Zelanda
        • 1218.43.64004 Boehringer Ingelheim Investigational Site
      • Tauranga, Nueva Zelanda
        • 1218.43.64002 Boehringer Ingelheim Investigational Site
  • Ucrania
      • Kharkiv, Ucrania
        • 1218.43.38004 Boehringer Ingelheim Investigational Site
      • Kharkov, Ucrania
        • 1218.43.38003 Boehringer Ingelheim Investigational Site
      • Kharkov, Ucrania
        • 1218.43.38006 Boehringer Ingelheim Investigational Site
      • Kiev, Ucrania
        • 1218.43.38005 Boehringer Ingelheim Investigational Site
      • Lugansk, Ucrania
        • 1218.43.38007 Boehringer Ingelheim Investigational Site
      • Ternopil, Ucrania
        • 1218.43.38008 Boehringer Ingelheim Investigational Site
      • Zaporizhzhya, Ucrania
        • 1218.43.38002 Boehringer Ingelheim 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 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

  • Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
  • Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
  • Age 18 or over and not older than 80 years

Exclusion criteria:

  • Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
  • Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  • Unstable or acute congestive heart failure

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
Experimental: BI 1356
patient to receive a tablet containing BI 1356 once daily
Droga: BI 1356
BI 1356 dosed once daily
Comparador de placebos: placebo
patient to receive a tablet identical to BI 1356 once daily
Droga: placebo
placebo matching BI 1356 taken once daily

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HbA1c Change From Baseline at Week 12
Periodo de tiempo: Baseline and Week 12
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HbA1c Change From Baseline at Week 52
Periodo de tiempo: Baseline and Week 52
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 52
HbA1c Change From Baseline at Week 18
Periodo de tiempo: Baseline and Week 18
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 18
HbA1c Change From Baseline at Week 24
Periodo de tiempo: Baseline and Week 24
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 24
HbA1c Change From Baseline at Week 30
Periodo de tiempo: Baseline and Week 30
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 30
HbA1c Change From Baseline at Week 36
Periodo de tiempo: Baseline and Week 36
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 36
HbA1c Change From Baseline at Week 42
Periodo de tiempo: Baseline and Week 42
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 42
HbA1c Change From Baseline at Week 48
Periodo de tiempo: Baseline and Week 48
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 48
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
Periodo de tiempo: Baseline and Week 52
The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
Baseline and Week 52
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
Periodo de tiempo: Baseline and Week 52
The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.
Baseline and Week 52
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
Periodo de tiempo: Baseline and Week 52
The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
Baseline and Week 52
FPG Change From Baseline at Week 12
Periodo de tiempo: Baseline and Week 12
This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Baseline and Week 12
FPG Change From Baseline at Week 18
Periodo de tiempo: Baseline and Week 18
Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Baseline and Week 18
FPG Change From Baseline at Week 24
Periodo de tiempo: Baseline and Week 24
This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 24
FPG Change From Baseline at Week 30
Periodo de tiempo: Baseline and Week 30
This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 30
FPG Change From Baseline at Week 36
Periodo de tiempo: Baseline and Week 36
This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 36
FPG Change From Baseline at Week 42
Periodo de tiempo: Baseline and Week 42
This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 42
FPG Change From Baseline at Week 48
Periodo de tiempo: Baseline and Week 48
This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 48
FPG Change From Baseline at week52
Periodo de tiempo: Baseline and Week 52
This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 52
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Periodo de tiempo: Baseline and Week 52
Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Baseline and Week 52
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Periodo de tiempo: first administration of randomised treatment to ....
Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
first administration of randomised treatment to ....

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

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

Enlaces Útiles

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 2008

Finalización primaria (Actual)

1 de enero de 2011

Fechas de registro del estudio

Enviado por primera vez

1 de diciembre de 2008

Primero enviado que cumplió con los criterios de control de calidad

1 de diciembre de 2008

Publicado por primera vez (Estimar)

2 de diciembre de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

20 de mayo de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

15 de mayo de 2014

Última verificación

1 de mayo de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1218.43
  • 2008-001569-27 (Número EudraCT: EudraCT)

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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