Segurança e eficácia da insulina inalada em pacientes com diabetes e asma ou DPOC
9 de setembro de 2019 atualizado por: Eli Lilly and Company
Um estudo paralelo, aberto e fundamental para avaliar a segurança e a eficácia do pó para inalação de insulina humana (HIIP) em comparação com a insulina injetável em pacientes com diabetes e DPOC ou asma
Fase 3, estudo aberto, randomizado para avaliar a segurança e a eficácia do sistema de insulina inalatória Lilly/Alkermes em comparação com a insulina injetada em pacientes com diabetes tipo 1 e tipo 2 com asma ou DPOC.
Os pacientes serão tratados por 12 meses com um período de acompanhamento de 2 meses.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
299
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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Buenos Aires, Argentina, C1181ACH
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Cordoba, Argentina, 5000
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Mendoza, Argentina, 5500
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Ramos Mejia, Argentina, B1704ETD
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Haskovo, Bulgária, 6300
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Pazardzhik, Bulgária, 4400
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Pleven, Bulgária, 5800
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Plovdiv, Bulgária, 4003
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Sofia, Bulgária, 1606
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Stara Zagora, Bulgária, 6003
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 3P4
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Newfoundland and Labrador
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St Johns, Newfoundland and Labrador, Canadá, A1B 3V6
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Ontario
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Corunna, Ontario, Canadá, N0N 1G0
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Niagara Falls, Ontario, Canadá, L2G1J4
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Sarnia, Ontario, Canadá, N7T 4X3
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Quebec
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Longueuil, Quebec, Canadá, J4N 1E1
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Sainte-Foy, Quebec, Canadá, G1V 4G2
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San Miguel, Chile, S/N
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Vina Del Mar, Chile, 2570017
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Singapore, Cingapura, 159964
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Bogota, Colômbia
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Zagreb, Croácia, HR-10000
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Alabama
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Montgomery, Alabama, Estados Unidos, 36106
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California
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Burbank, California, Estados Unidos, 91505
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Greenbrae, California, Estados Unidos, 94904
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Connecticut
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Norwich, Connecticut, Estados Unidos, 06360
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Florida
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Clearwater, Florida, Estados Unidos, 33756
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Hollywood, Florida, Estados Unidos, 33021
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Jacksonville, Florida, Estados Unidos, 32204
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New Port Richey, Florida, Estados Unidos, 34652
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Ocala, Florida, Estados Unidos, 34471
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West Palm Beach, Florida, Estados Unidos, 33401
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Illinois
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Belvidere, Illinois, Estados Unidos, 61008
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Chicago, Illinois, Estados Unidos, 60631
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Springfield, Illinois, Estados Unidos, 62704
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Kansas
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Topeka, Kansas, Estados Unidos, 66606
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40213
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Maryland
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Baltimore, Maryland, Estados Unidos, 21204
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Massachusetts
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Brockton, Massachusetts, Estados Unidos, 02301
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89146
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
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Morehead City, North Carolina, Estados Unidos, 28557
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Ohio
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Kettering, Ohio, Estados Unidos, 45429
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Oregon
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Medford, Oregon, Estados Unidos, 97504
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Pennsylvania
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Downingtown, Pennsylvania, Estados Unidos, 19335
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Levittown, Pennsylvania, Estados Unidos, 19056
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Sellersville, Pennsylvania, Estados Unidos, 18960
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South Carolina
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Simpsonville, South Carolina, Estados Unidos, 29681
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Spartanburg, South Carolina, Estados Unidos, 29303
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57105
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Texas
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El Paso, Texas, Estados Unidos, 79902
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Houston, Texas, Estados Unidos, 77090
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Humble, Texas, Estados Unidos, 77338
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Midland, Texas, Estados Unidos, 79705
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San Antonio, Texas, Estados Unidos, 78229
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Virginia
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Norfolk, Virginia, Estados Unidos, 23502
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Washington
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Tacoma, Washington, Estados Unidos, 98405
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Barangay Pembo, Filipinas, 1218
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Dillman, Filipinas
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Ermita, Filipinas
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Espana, Filipinas
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Manila, Filipinas, 1007
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Pasig City, Filipinas
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Quezon City, Filipinas, 1102
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San Juan, Filipinas
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Kwun Tong, Hong Kong
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Budapest, Hungria, 1076
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Eger, Hungria, 3300
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Gyula, Hungria, 5701
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Kalocsa, Hungria, 6300
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Kecskemet, Hungria, 6000
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Nyiregyhaza, Hungria, H-4400
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Szekesfehervar, Hungria, 8000
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Szolnok, Hungria, 5000
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Mexico City, México, 11650
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Monterrey, México, 64460
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Ponce, Porto Rico, 00732
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Bangkok, Tailândia, 10330
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Bangkoknoi, Tailândia, 10700
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Taichung, Taiwan, 407
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Ahmedabad, Índia, 38009
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Bangalore, Índia, 560017
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Chennai, Índia, 600010
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Cochin, Índia, 682026
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Coimbatore, Índia, 643209
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Gandhinagar, Índia, 382428
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Hyderabaad, Índia, 500033
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kolkatta, Índia, 700054
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kormangala, Índia, 560034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Mangalore, Índia, 575001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Mumbai, Índia, 400016
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Nagpur, Índia, 440012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
New Delhi, Índia, 110057
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Noida, Índia, 201301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
P.O Ernakulam, Índia, 682304
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Porur, Índia, 600116
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Pune, Índia, 411011
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Secunderabad, Índia, 800003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Tamil Nadu, Índia, 600 006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Vellore, Índia, 632 004
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
Critério de inclusão:
- Diabetes tipo 1 ou tipo 2
- asma ou DPOC
Critério de exclusão:
- Hábito atual de fumar
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 |
|---|---|
|
Experimental: 1
|
dose específica do paciente, inalação, antes das refeições, 12 meses
Outros nomes:
|
|
Comparador Ativo: 2
|
dose específica do paciente, injetada, antes das refeições, 12 meses.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Testar a hipótese de que o controle glicêmico alcançado com Pó para Inalação de Insulina Humana pré-prandial não é inferior ao obtido com insulina injetável, conforme medido pela alteração média desde a linha de base até o ponto final em HbA1c.
Prazo: 12 meses
|
12 meses
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Comparar os efeitos da Insulina Humana Pó para Inalação pré-prandial e da insulina injetável sobre o VEF1 e a CVF antes e após a inalação do broncodilatador.
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos pré-prandial de Insulina Humana em Pó para Inalação e insulina injetável na resposta ao broncodilatador conforme medido pela variação entre VEF1 e CVF pré e pós-broncodilatador
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos da Insulina Humana Pó para Inalação pré-prandial e da insulina injetável na DLco.
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos do Pó para Inalação de Insulina Humana pré-prandial e da insulina injetável na capacidade pulmonar total
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos pré-prandiais de Insulina Humana em Pó para Inalação e insulina injetável na segurança, conforme avaliado pelos níveis de anticorpos à insulina, eventos adversos e episódios de hipoglicemia
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos do Pó para Inalação de Insulina Humana pré-prandial e da insulina injetável na segurança avaliada por radiografia de tórax.
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos pré-prandiais de Insulina Humana em Pó para Inalação e insulina injetável na segurança avaliada pelo Questionário Respiratório de St. George.
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos pré-prandiais de Insulina Humana em Pó para Inalação e insulina injetável na segurança avaliada pelo Teste de Caminhada de Seis Minutos com a Escala Borg CR10.
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos da insulina humana em pó para inalação pré-prandial e da insulina injetável na proporção de pacientes que atingem ou mantêm HbA1c menor ou igual a 6,5% e que atingem ou mantêm HbA1c < 7%.
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos da Insulina Humana Pré-prandial para Inalação em Pó e injetável. insulina na proporção de pts com tipo 2 em agente(s) oral(is) rand. apenas para Insulina Humana em Pó para Inalação ou apenas glargina que não atingirem HbA1c <7,5% após seis meses.
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos da Insulina Humana em Pó pré-prandial e da insulina injetável no controle glicêmico, conforme avaliado pelos perfis de glicemia de 8 pontos automonitorados
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos do Pó para Inalação de Insulina Humana pré-prandial e da insulina injetável nas necessidades de dose de insulina (incluindo insulina total, basal e/ou em bolus)
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos da insulina humana em pó para inalação pré-prandial e da insulina injetável em questionários de resultados relatados pelo paciente para avaliar o estado geral de saúde.
Prazo: 12 meses
|
12 meses
|
|
Comparar os efeitos do Pó para Inalação de Insulina Humana pré-prandial e da insulina injetável na utilização de recursos.
Prazo: 12 meses
|
12 meses
|
|
Avaliar a confiabilidade do inalador de insulina em pacientes randomizados para tratamento com Insulina Humana em Pó para Inalação.
Prazo: ao longo do estudo
|
ao longo do estudo
|
|
Explorar o impacto da Insulina Humana em Pó para Inalação no pico de fluxo e na variabilidade do pico de fluxo no estudo com pacientes com asma.
Prazo: 12 meses
|
12 meses
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hour, EST), Eli Lilly and Company
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 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
7 de setembro de 2005
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de setembro de 2005
Primeira postagem (Estimativa)
12 de setembro de 2005
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de setembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2019
Última verificação
1 de setembro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doenças Respiratórias
- Doenças do sistema imunológico
- Doenças pulmonares
- Hipersensibilidade, Imediata
- Doenças do Sistema Endócrino
- Doenças brônquicas
- Doenças Pulmonares Obstrutivas
- Hipersensibilidade Respiratória
- Hipersensibilidade
- Diabetes Mellitus
- Doença Pulmonar Obstrutiva Crônica
- Asma
- Hipoglicemiantes
- Efeitos Fisiológicos das Drogas
- Insulina
- Insulina, Globina Zinco
Outros números de identificação do estudo
- 7091
- H7U-MC-IDAS (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
Os dados anônimos individuais do nível do paciente serão fornecidos em um ambiente de acesso seguro após a aprovação de uma proposta de pesquisa e um acordo de compartilhamento de dados assinado.
Prazo de Compartilhamento de IPD
Os dados estão disponíveis 6 meses após a publicação primária e aprovação da indicação estudada nos EUA e na UE, o que ocorrer mais tarde.
Os dados ficarão indefinidamente disponíveis para solicitação.
Critérios de acesso de compartilhamento IPD
Uma proposta de pesquisa deve ser aprovada por um painel de revisão independente e os pesquisadores devem assinar um acordo de compartilhamento de dados.
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Plano de Análise Estatística (SAP)
- Relatório de Estudo Clínico (CSR)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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 .