Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial.
Adolescent
Blood Glucose
/ drug effects
Child
Diabetes Mellitus, Type 1
/ blood
Dose-Response Relationship, Drug
Equivalence Trials as Topic
Fasting
/ blood
Female
Glycated Hemoglobin
/ drug effects
Humans
Hyperglycemia
/ blood
Hypoglycemia
/ blood
Hypoglycemic Agents
/ administration & dosage
Incidence
Insulin Glargine
/ administration & dosage
Male
Journal
Diabetes care
ISSN: 1935-5548
Titre abrégé: Diabetes Care
Pays: United States
ID NLM: 7805975
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
received:
27
09
2019
accepted:
20
04
2020
pubmed:
21
5
2020
medline:
16
3
2021
entrez:
21
5
2020
Statut:
ppublish
Résumé
To compare efficacy and safety of insulin glargine 300 units/mL (Gla-300) and 100 units/mL (Gla-100) in children and adolescents (6-17 years old) with type 1 diabetes. EDITION JUNIOR was a noninferiority, international, open-label, two-arm, parallel-group, phase 3b trial. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated to achieve fasting self-monitored plasma glucose levels of 90-130 mg/dL (5.0-7.2 mmol/L), with continuation of prior prandial insulin. The primary end point was change in HbA In 463 randomized participants (Gla-300, Gla-300 provided similar glycemic control and safety profiles to Gla-100 in children and adolescents with type 1 diabetes, indicating that Gla-300 is a suitable therapeutic option in this population.
Identifiants
pubmed: 32430458
pii: dc19-1926
doi: 10.2337/dc19-1926
pmc: PMC7305011
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin Glargine
2ZM8CX04RZ
Banques de données
figshare
['10.2337/figshare.12174711']
ClinicalTrials.gov
['NCT02735044']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1512-1519Subventions
Organisme : NIDDK NIH HHS
ID : P30 DK045735
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
Informations de copyright
© 2020 by the American Diabetes Association.