Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes
7 de março de 2018 atualizado por: Eli Lilly and Company
A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus.
This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes.
The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
494
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
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Aschaffenburg, Alemanha, 63739
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Münster, Alemanha, 48145
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Buenos Aires, Argentina, C1213AAH
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Aalst, Bélgica, 9300
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Brussels, Bélgica, 1070
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Edegem, Bélgica, 2650
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Gent, Bélgica, 9000
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Leuven, Bélgica, 3000
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
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Florida
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Miami, Florida, Estados Unidos, 33136
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Georgia
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Atlanta, Georgia, Estados Unidos, 30309
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83404
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Illinois
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Springfield, Illinois, Estados Unidos, 62704
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46250
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Maryland
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Baltimore, Maryland, Estados Unidos, 21204
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503
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New York
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New York, New York, Estados Unidos, 10025
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
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Texas
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Dallas, Texas, Estados Unidos, 75246
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El Paso, Texas, Estados Unidos, 79935
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San Antonio, Texas, Estados Unidos, 78229
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Utah
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Ogden, Utah, Estados Unidos, 84403
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Angers, França, 49033
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Paris, França, 75475
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Poitiers, França, 86000
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Toulouse, França, 31054
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Tours, França, 37044
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Milano, Itália, 20142
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Perugia, Itália, 06100
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Guadalajara, México, 44340
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Mexico City, México, 06726
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Toa Baja, Porto Rico, 00950
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Bangalore, Índia, 560 054
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Chennai, Índia, 600 013
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Cochin, Índia, 682026
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Mumbai, Índia, 400 007
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New Delhi, Índia, 110 029
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Type 1 diabetes for at least 24 months
- Have an HbA1c less than or equal to 11%
- Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
- Non-smoker
Exclusion Criteria:
- Require a daily total insulin dosage greater than 150 U at screening
- Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
- Systemic glucocorticoid therapy
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis
- History of lung transplantation and/or lung cancer
- Diagnosed with pneumonia in the 3 months prior to screening
- History of renal transplantation
- Active or untreated malignancy
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 1
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patient specific dose, inhaled, before meals, 6 months
Outros nomes:
patient specific dose, injectable, before meals, 6 months
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Comparador Ativo: 2
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patient specific dose, injectable, before meals, 6 months
patient specific dose, injected, before meals, 6 months
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.
Prazo: 6 months
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6 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Insulin dose requirements
Prazo: throughout the study
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throughout the study
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Insulin antibody binding levels
Prazo: baseline, 1 month, 6 months, follow-up
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baseline, 1 month, 6 months, follow-up
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To compare HbAlc change
Prazo: 6 months
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6 months
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To assess rate and incidence of hypoglycemia
Prazo: 6 months
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6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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.
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 agosto de 2006
Conclusão Primária (Real)
1 de maio de 2008
Conclusão do estudo (Real)
1 de maio de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de julho de 2006
Primeira postagem (Estimativa)
25 de julho de 2006
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de março de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de março de 2018
Última verificação
1 de março de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 9627
- H7U-MC-IDAV
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 .