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Afrezza · INHALE-1

Afrezza® INHALE-1 Study in Pediatrics

Ensayo de MANNKIND CORP en Diabetes Mellitus tipo 1 · Diabetes Mellitus tipo 2.

Más ensayos de: Diabetes tipo 1 · Diabetes tipo 2.

Fase

Fase 3

Estado

Completado

Participantes

319

previstos

Centros

39

Fin del objetivo primario

oct 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2021.

Qué mide

Cambio en HbA1c (26 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroINHALE-1 is a Phase 3, open-label, randomized clinical study evaluating the efficacy and safety of Afrezza in combination with a basal insulin (i.e., the Afrezza group) versus insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin (i.e., the Rapid-acting Insulin Analog \[RAA\] injection group) in pediatric subjects with type 1 or type 2 diabetes mellitus. Following 26 weeks of randomized treatment (i.e., Afrezza or RAA injection combined with a basal insulin), all subjects will enter a treatment extension where subjects will receive Afrezza until Week 52. The purpose of the treatment extension is to assess safety and efficacy with continued use of Afrezza. Pediatric subjects ≥4 and \<18 years of age will be enrolled in this study. Subjects will be randomly assigned in a 1:1 ratio to either the Afrezza group or the RAA injection group. The study is composed of: * Up to 5-week screening/run-in period * 26 week randomized treatment period * 26-week treatment extension * 4-week follow-up period

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Todos los de MNKD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04974528), actualizada en may 2025.