A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen.
Adult
Circadian Rhythm
/ drug effects
Clinical Trials, Phase III as Topic
/ statistics & numerical data
Diabetes Mellitus, Type 2
/ blood
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Therapy, Combination
Female
Humans
Hypoglycemia
/ chemically induced
Insulin
/ administration & dosage
Insulin Glargine
/ administration & dosage
Male
Multicenter Studies as Topic
/ statistics & numerical data
Randomized Controlled Trials as Topic
/ statistics & numerical data
Retrospective Studies
Risk Factors
Time Factors
basal insulin
hypoglycaemia
type 2 diabetes
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
02 2019
02 2019
Historique:
received:
06
06
2018
revised:
24
08
2018
accepted:
26
08
2018
pubmed:
31
8
2018
medline:
10
9
2019
entrez:
31
8
2018
Statut:
ppublish
Résumé
The EDITION trials in type 2 diabetes demonstrated comparable glycaemic control with less nocturnal and anytime (24-hour) hypoglycaemia for insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100). However, the predefined nocturnal window (0:00-5:59 AM) may not be the most relevant for clinical practice. This post-hoc analysis compared expansions of the predefined nocturnal interval during basal insulin treatment without prandial insulin. Patient-level, 6-month data, pooled from the EDITION 2 and 3 trials and the EDITION JP 2 trial (N = 1922, basal insulin only) were analysed. Accompanying hypoglycaemia during treatment with Gla-300 was compared to that during treatment with Gla-100, using predefined (0:00-5:59 AM) and expanded (10:00 PM-5:59 AM, 0:00-7:59 AM, 10:00 PM to pre-breakfast SMPG) windows. Confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemic events were reported most frequently between 6:00 AM and 8:00 AM. Windows expanded beyond 6:00 AM included more events than other windows. The percentage of participants with at least one event was lower with Gla-300 than Gla-100 in all windows examined. Expanding the nocturnal interval allows better assessment of the risk of hypoglycaemia associated with basal insulin. The risk of nocturnal hypoglycaemia was consistently lower with Gla-300 versus Gla-100 using all four windows.
Identifiants
pubmed: 30160030
doi: 10.1111/dom.13515
pmc: PMC6586031
doi:
Substances chimiques
Insulin
0
Insulin Glargine
2ZM8CX04RZ
Banques de données
ClinicalTrials.gov
['NCT01499095', 'NCT01676220', 'NCT01689142']
Types de publication
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
402-407Informations de copyright
© 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
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