Lower risk of severe hypoglycaemia with insulin glargine 300 U/mL versus glargine 100 U/mL in participants with type 1 diabetes: A meta-analysis of 6-month phase 3 clinical trials.
basal insulin
glycaemic control
hypoglycaemia
insulin analogues
meta-analysis
type 1 diabetes
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
received:
20
03
2020
revised:
20
05
2020
accepted:
04
06
2020
pubmed:
10
6
2020
medline:
25
6
2021
entrez:
10
6
2020
Statut:
ppublish
Résumé
Severe hypoglycaemia (SH) remains a challenge to people with type 1 diabetes (T1DM), and new-generation basal insulins may improve patient outcomes. This post hoc meta-analysis explored the risk of SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in a pooled population with T1DM from three randomized, multicentre, 6-month similarly designed phase 3 trials: EDITION 4, EDITION JP 1 and EDITION JUNIOR. Endpoints included incidence and time to first occurrence of SH. Among 629 and 626 participants randomized to Gla-300 and Gla-100, respectively, glycated haemoglobin reductions were similar. Fewer participants experienced ≥1 SH event with Gla-300 (6.2%) than with Gla-100 (9.3%). From baseline to month 6, the risk of a first SH event was lower with Gla-300: hazard ratio 0.65 [95% confidence interval (CI) 0.44-0.98; stratified log-rank test P = 0.038]. SH event rates were numerically lower with Gla-300 versus Gla-100 from baseline to month 6 [relative risk (RR) 0.80 (95% CI 0.49-1.29); P = 0.356] and baseline to week 8 [RR 0.73 (95% CI 0.37-1.44); P = 0.369]. Thus, Gla-300 demonstrated similar glycaemic control with lower risk of SH versus Gla-100, particularly during the titration period.
Identifiants
pubmed: 32515543
doi: 10.1111/dom.14109
pmc: PMC7540568
doi:
Substances chimiques
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin Glargine
2ZM8CX04RZ
Types de publication
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1880-1885Subventions
Organisme : The meta-analysis and clinical trials considered in the analysis were sponsored by Sanofi, Paris, France. Editorial and writing assistance was provided by Jennina Taylor-Wells, PhD, of Fishawack Communications Ltd., UK, and was funded by Sanofi.
Pays : International
Informations de copyright
© 2020 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
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