Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes
7 de março de 2018 atualizado por: Eli Lilly and Company
A Pivotal Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder in Patients With Type 1 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 1 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)
385
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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Aalst, Bélgica
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Arlon, Bélgica
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Brussels, Bélgica
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Edegem, Bélgica
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Leuven, Bélgica
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Liege, Bélgica
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Manitoba
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Winnipeg, Manitoba, Canadá
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Ontario
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Corunna, Ontario, Canadá
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Niagara Falls, Ontario, Canadá
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Peterborough, Ontario, Canadá
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Sarnia, Ontario, Canadá
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Quebec
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Montreal, Quebec, Canadá
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Zagreb, Croácia
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California
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Sacramento, California, Estados Unidos
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Walnut Creek, California, Estados Unidos
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Colorado
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Aurora, Colorado, Estados Unidos
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Denver, Colorado, Estados Unidos
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Delaware
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Newark, Delaware, Estados Unidos
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Florida
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Hollywood, Florida, Estados Unidos
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Jacksonville, Florida, Estados Unidos, 32204
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Largo, Florida, Estados Unidos
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New Port Richey, Florida, Estados Unidos
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West Palm Beach, Florida, Estados Unidos
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Georgia
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Atlanta, Georgia, Estados Unidos
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Idaho
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Idaho Falls, Idaho, Estados Unidos
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Illinois
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Chicago, Illinois, Estados Unidos
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Springfield, Illinois, Estados Unidos
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Indiana
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Indianapolis, Indiana, Estados Unidos
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Kentucky
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Louisville, Kentucky, Estados Unidos
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Maryland
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Baltimore, Maryland, Estados Unidos
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Missouri
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Saint Louis, Missouri, Estados Unidos
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Nebraska
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Omaha, Nebraska, Estados Unidos
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New Jersey
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North Plainfield, New Jersey, Estados Unidos, 07060
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New York
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Flushing, New York, Estados Unidos, 11365
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Lake Success, New York, Estados Unidos
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New Hyde Park, New York, Estados Unidos
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Staten Island, New York, Estados Unidos
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North Carolina
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Morehead City, North Carolina, Estados Unidos, 28557
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Raleigh, North Carolina, Estados Unidos
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Oregon
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Medford, Oregon, Estados Unidos
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Pennsylvania
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Downingtown, Pennsylvania, Estados Unidos
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Sellersville, Pennsylvania, Estados Unidos, 34652
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos
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Texas
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Dallas, Texas, Estados Unidos
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Houston, Texas, Estados Unidos
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San Antonio, Texas, Estados Unidos
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Washington
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Renton, Washington, Estados Unidos, 98055
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53209
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Budapest, Hungria
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Debrecen, Hungria
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Eger, Hungria
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Gyula, Hungria
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Kecskemet, Hungria
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Nyiregyhaza, Hungria
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Szeged, Hungria
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Szolnok, Hungria
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Bangalore, Índia
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Kochin, Índia
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Mumbai, Índia
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New Dehli, Índia
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Noida, Índia
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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
- Non smoker
- Normal lung function
Exclusion Criteria:
- Significant pulmonary, hepatic, or renal disease
- Severe 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, up to 36 months
Outros nomes:
patient specific dose, injectable, as needed, 24 months up to 36 months
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Comparador Ativo: 2
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patient specific dose, injectable, as needed, 24 months up to 36 months
patient specific dose, injectable, before meals, 24 months, up to 36 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 change in baseline to endpoint in HbA1c in type 1 diabetic patients.
Prazo: 24 months
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24 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to FEV1, FVC, and total lung capacity (TLC), and diffusing capacity of the lung for carbon monoxide (DLCO).
Prazo: 24 months
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24 months
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To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by insulin antibody binding levels, adverse events, and episodes of hypoglycemia
Prazo: 24 months
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24 months
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To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety using serial HRCT scans of the chest
Prazo: 24 months
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24 months
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To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by Six-Minute Walk Test with the Borg CR10 scale to access perceived exertion.
Prazo: 24 months
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24 months
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To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to proportion of patients who achieve or maintain an HbA1c < 7.0 %.
Prazo: 24 months
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24 months
|
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To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to insulin dose requirements ( total, preprandial, and basal insulin)
Prazo: 24 months
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24 months
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To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to Patient reported questionnaires.
Prazo: 24 months
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24 months
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To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to resource utilization
Prazo: 24 months
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24 months
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To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.
Prazo: throughout the study
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throughout the study
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To explore differences in cough and other pulmonary symptoms in patients treated with Human Insulin Inhalation Powder or preprandial injectable insulin using the Pulmonary Symptom Questionnaire.
Prazo: months 32, 38, 40 and ED visits
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months 32, 38, 40 and ED visits
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To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to glycemic control as assessed by the 8-point self-monitored blood glucose profiles
Prazo: 24 months
|
24 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 julho de 2005
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
4 de agosto de 2005
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de agosto de 2005
Primeira postagem (Estimativa)
8 de agosto de 2005
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
- 6120
- H7U-MC-IDAH
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 .