Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
6 de septiembre de 2019 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
415
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 10115
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Dresden, Alemania, 01307
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Erlangen, Alemania, 91054
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Frankfurt, Alemania, 60596
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Leipzig, Alemania, D-04103
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Mainz, Alemania, 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, Hungría, H-1139
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Mako, Hungría, 6900
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Veszprem, Hungría, 8200
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Zalaegerszeg, Hungría, 8900
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Bangalore, India, 560010
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Mumbai, India, 400 007
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Pune, India, 411005
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Catania, Italia, 95100
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Genova, Italia, 16132
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Milano, Italia, 20132
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Pisa, Italia, 56100
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Rome, Italia, 00168
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Mexico City, México, 06700
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Monterrey, México, 64410
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Katowice, Polonia, 40-044
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Lublin, Polonia, 20-954
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Olesnica, Polonia
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Coimbra, Portugal, 3000-076
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Lisbon, Portugal, 1250-203
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Manatí, Puerto Rico, 00674
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San Juan, Puerto Rico, 00907
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Yabucoa, Puerto Rico, 00767
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Changhua, Taiwán, 500
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Neihu Taipei, Taiwán, 114
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Yungkang City, Taiwán, 710
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 1
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patient specific dose, inhaled, before meals, 24 months
Otros nombres:
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Comparador activo: 2
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patient specific dose, injectable, before meals, 24 months
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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
Periodo de tiempo: 6 months
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 24 months
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24 months
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To test dose titration methods
Periodo de tiempo: 6 months
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6 months
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To assess inhaler reliability
Periodo de tiempo: 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
Periodo de tiempo: 3 months, 6 months
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3 months, 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2006
Finalización primaria (Actual)
1 de mayo de 2008
Finalización del estudio (Actual)
1 de mayo de 2008
Fechas de registro del estudio
Enviado por primera vez
10 de mayo de 2006
Primero enviado que cumplió con los criterios de control de calidad
10 de mayo de 2006
Publicado por primera vez (Estimar)
12 de mayo de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
6 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 9626
- H7U-MC-IDAU (Otro identificador: Eli Lilly and Company)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .