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Technosphere Insulin SAR439065…

PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)

Ensayo de MANNKIND CORP en Diabetes tipo 1.

Más ensayos de: Diabetes tipo 1.

Fase

Fase 1

Estado

Completado

Participantes

22

previstos

Centros

1

Fin del objetivo primario

nov 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jul 2015.

Qué mide

Assessment of PK parameter: area under the serum insulin concentration time curve from time 0 to 8H (INS-AUC0-8H) (del registro, en inglés) (8 horas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp setting. To characterize the within-subject variability in the metabolic activity (pharmacodynamic \[PD\]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp setting. Secondary Objectives: To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting. To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting. To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting.

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Todos los de MNKD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02485327), actualizada en mar 2017.