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
de 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.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Marqueurs biologiques
/
Diabète de type 1
/
Hypoglycémiants
/
Insuline
/
Anticorps anti-insuline
Type d'étude:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limites:
Child
/
Female
/
Humans
/
Male
Langue:
En
Journal:
J Pediatr Endocrinol Metab
Sujet du journal:
ENDOCRINOLOGIA
/
PEDIATRIA
Année:
2020
Type de document:
Article
Pays d'affiliation:
États-Unis d'Amérique