A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma

CompletadoFase 3ClinicalTrials.gov

ID: NCT00157339Tipo: INTERVENTIONALInicio: 1 de ago de 2005Fin estimado: 1 de may de 2008

Traducción no disponible, mostrando original

Resumen

Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Type 1 or type 2 diabetes
asthma or COPD

Criterios de exclusión

Current smoking habit

Intervenciones

drug

Human Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 12 months

drug

injected insulin

patient specific dose, injected, before meals, 12 months.

Ubicaciones

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.

Buenos Aires, Argentina

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.

Córdoba, Argentina

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.

Mendoza, Argentina

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.

Ramos Mejía, Argentina

Patrocinadores

PrincipalEli Lilly and Company

ColaboradorAlkermes, Inc.

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Pivotal, Open-Label, Parallel Study to Evaluate the Saf... | EligiMed