Efficacy and Safety of Inhaled Human Insulin (Exu hera®) Compared to Subcutaneous Insulin in Children Ages 6 to 11 Years with Type 1 Diabetes Mellitus: Results of a 3-Month, Randomized, Parallel Trial.
J Pediatr Endocrinol Metab
; 21(6): 555-568, 2020 Oct 22.
Article
em En
| MEDLINE
| ID: mdl-33600687
ABSTRACT
AIM:
To compare the efficacy and safety of Exubera® (EXU) with subcutaneous (SC) insulin in children, ages 6-11 years, with type 1 diabetes mellitus. DESIGN ANDMETHODS:
121 children were randomized to receive EXU or SC insulin, plus intermediate/ long-acting insulin for 12 weeks. Change in HbA1c was the primary efficacy endpoint.RESULTS:
Decreases from baseline HbA1c were comparable between treatment groups ( difference between adjusted mean decrease from baseline [EXU - SC insulin], -0.23 [95% CI, -0.49, 0.03]). Differences between groups on pulmonary function tests were small and not significant. Mild to moderate cough occurred in 24.6% of EXU versus 6.8% of SC insulin patients. The risk for hypoglycemia was comparable between EXU and SC insulin (relative risk 0.88 [95% CI, 0.71, 1.11]). Increased insulin antibodies with EXU were not associated with clinical findings.CONCLUSION:
The efficacy and safety profiles shown in this study are the foundation for further investigation of EXU in this population.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Biomarcadores
/
Diabetes Mellitus Tipo 1
/
Hipoglicemiantes
/
Insulina
/
Anticorpos Anti-Insulina
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Child
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
J Pediatr Endocrinol Metab
Ano de publicação:
2020
Tipo de documento:
Article