Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial.
Adolescent
Blood Glucose
/ drug effects
Child
Child, Preschool
Diabetes Mellitus, Type 1
/ blood
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Drug Therapy, Combination
Female
Glycated Hemoglobin
/ drug effects
Humans
Hypoglycemia
/ chemically induced
Hypoglycemic Agents
/ administration & dosage
Infant
Insulin Aspart
/ administration & dosage
Insulin, Long-Acting
/ administration & dosage
Male
Meals
Postprandial Period
/ drug effects
Treatment Outcome
Journal
Diabetes care
ISSN: 1935-5548
Titre abrégé: Diabetes Care
Pays: United States
ID NLM: 7805975
Informations de publication
Date de publication:
07 2019
07 2019
Historique:
received:
02
01
2019
accepted:
09
04
2019
pubmed:
12
5
2019
medline:
21
3
2020
entrez:
12
5
2019
Statut:
ppublish
Résumé
To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes. After a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years) to double-blind mealtime faster aspart ( At week 26, mealtime and postmeal faster aspart were noninferior to IAsp regarding change from baseline in HbA In children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA
Identifiants
pubmed: 31076415
pii: dc19-0009
doi: 10.2337/dc19-0009
pmc: PMC6973646
doi:
Substances chimiques
Blood Glucose
0
Drug Combinations
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin, Long-Acting
0
insulin degludec, insulin aspart drug combination
0
insulin degludec
54Q18076QB
Insulin Aspart
D933668QVX
Banques de données
ClinicalTrials.gov
['NCT02670915']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1255-1262Subventions
Organisme : NIDDK NIH HHS
ID : P30 DK036836
Pays : United States
Informations de copyright
© 2019 by the American Diabetes Association.
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