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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 maio de 2014 atualizado 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

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

133

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Austrália
      • Adelaide, SA, Austrália
        • 1218.43.61005 Boehringer Ingelheim Investigational Site
      • Herston, QLD, Austrália
        • 1218.43.61002 Boehringer Ingelheim Investigational Site
    • New South Wales
      • Gosford, New South Wales, Austrália
        • 1218.43.61009 Boehringer Ingelheim Investigational Site
    • Queensland
      • Auchenflower, Queensland, Austrália
        • 1218.43.61010 Boehringer Ingelheim Investigational Site
      • Kippa Ring, Queensland, Austrália
        • 1218.43.61006 Boehringer Ingelheim Investigational Site
    • Victoria
      • Reservoir, Victoria, Austrália
        • 1218.43.61007 Boehringer Ingelheim Investigational Site
      • Richmond, Victoria, Austrália
        • 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
  • Nova Zelândia
      • Auckland, Nova Zelândia
        • 1218.43.64001 Boehringer Ingelheim Investigational Site
      • Christchurch, Nova Zelândia
        • 1218.43.64003 Boehringer Ingelheim Investigational Site
      • Takpuna, Nova Zelândia
        • 1218.43.64004 Boehringer Ingelheim Investigational Site
      • Tauranga, Nova Zelândia
        • 1218.43.64002 Boehringer Ingelheim Investigational Site
  • Ucrânia
      • Kharkiv, Ucrânia
        • 1218.43.38004 Boehringer Ingelheim Investigational Site
      • Kharkov, Ucrânia
        • 1218.43.38003 Boehringer Ingelheim Investigational Site
      • Kharkov, Ucrânia
        • 1218.43.38006 Boehringer Ingelheim Investigational Site
      • Kiev, Ucrânia
        • 1218.43.38005 Boehringer Ingelheim Investigational Site
      • Lugansk, Ucrânia
        • 1218.43.38007 Boehringer Ingelheim Investigational Site
      • Ternopil, Ucrânia
        • 1218.43.38008 Boehringer Ingelheim Investigational Site
      • Zaporizhzhya, Ucrânia
        • 1218.43.38002 Boehringer Ingelheim Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: BI 1356
patient to receive a tablet containing BI 1356 once daily
Medicamento: BI 1356
BI 1356 dosed once daily
Comparador de Placebo: placebo
patient to receive a tablet identical to BI 1356 once daily
Medicamento: placebo
placebo matching BI 1356 taken once daily

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
HbA1c Change From Baseline at Week 12
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
HbA1c Change From Baseline at Week 52
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de dezembro de 2008

Conclusão Primária (Real)

1 de janeiro de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

1 de dezembro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de dezembro de 2008

Primeira postagem (Estimativa)

2 de dezembro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

20 de maio de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de maio de 2014

Última verificação

1 de maio de 2014

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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