Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
6 de setembro de 2019 atualizado por: Eli Lilly and Company
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes.
Patients will be treated for 24 months with a 2-month follow-up period.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
415
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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Berlin, Alemanha, 10115
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Dresden, Alemanha, 01307
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Erlangen, Alemanha, 91054
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Frankfurt, Alemanha, 60596
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Leipzig, Alemanha, D-04103
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Mainz, Alemanha, D-55116
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Fortaleza, Brasil, 60120-020
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Porto Alegre, Brasil, 90035-003
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São Paulo, Brasil, 04020041
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California
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Sacramento, California, Estados Unidos, 95825
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Santa Ana, California, Estados Unidos, 92705
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Florida
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Jacksonville, Florida, Estados Unidos, 32204
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Miami, Florida, Estados Unidos, 33156
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
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New Jersey
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Hamilton, New Jersey, Estados Unidos, 08610
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29605
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Utah
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Ogden, Utah, Estados Unidos, 84403
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25304
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Budapest, Hungria, H-1139
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Mako, Hungria, 6900
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Veszprem, Hungria, 8200
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Zalaegerszeg, Hungria, 8900
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Catania, Itália, 95100
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Genova, Itália, 16132
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Milano, Itália, 20132
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Pisa, Itália, 56100
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Rome, Itália, 00168
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Mexico City, México, 06700
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Monterrey, México, 64410
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Katowice, Polônia, 40-044
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Lublin, Polônia, 20-954
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Olesnica, Polônia
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Manatí, Porto Rico, 00674
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San Juan, Porto Rico, 00907
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Yabucoa, Porto Rico, 00767
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Coimbra, Portugal, 3000-076
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Lisbon, Portugal, 1250-203
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Changhua, Taiwan, 500
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Neihu Taipei, Taiwan, 114
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Yungkang City, Taiwan, 710
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Bangalore, Índia, 560010
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Mumbai, Índia, 400 007
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Pune, Índia, 411005
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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 2 diabetes
- Non smoker
- Normal lung function
Exclusion Criteria:
- Pulmonary, hepatic, or renal disease
- Congestive heart failure
- Active malignancy
- Systemic glucocorticoid therapy
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, 24 months
Outros nomes:
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Comparador Ativo: 2
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patient specific dose, injectable, before meals, 24 months
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin
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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To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Prazo: 24 months
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24 months
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To compare inhaled human insulin to injectable insulin over time with respect to change on body weight
Prazo: baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction
Prazo: baseline, 6 months, 12 months, 18 months, 24 months
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baseline, 6 months, 12 months, 18 months, 24 months
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To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c
Prazo: baseline and every visit
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baseline and every visit
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To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia
Prazo: throughout the study
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throughout the study
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To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements
Prazo: 24 months
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24 months
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To test dose titration methods
Prazo: 6 months
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6 months
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To assess inhaler reliability
Prazo: throughout the study
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throughout the study
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To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients
Prazo: 3 months, 6 months
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3 months, 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 abril 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
10 de maio de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de maio de 2006
Primeira postagem (Estimativa)
12 de maio de 2006
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de setembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de setembro de 2019
Última verificação
1 de setembro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 9626
- H7U-MC-IDAU (Outro identificador: Eli Lilly and Company)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Prazo de Compartilhamento de IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
Critérios de acesso de compartilhamento IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
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 .