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Technosphere Insulin

A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes

Ensayo de MANNKIND CORP en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 2

Estado

Completado

Participantes

30

previstos

Centros

1

Fin del objetivo primario

ene 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2007.

Qué mide

Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge (0-480 minutes) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit. Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit. For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.

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Todos los de MNKD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00570687), actualizada en oct 2014.