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Effectiveness and safety of insulin glargine 300 U/mL in insulin-naïve individuals according to diabetes duration : Results from the REALI European pooled data analysis
Gourdy, P. (Toulouse University)
Bonadonna, R.C. (University of Parma)
Mauricio Puente, Dídac (Institut de Recerca Sant Pau)
Müller-Wieland, Dirk (University Hospital Aachen (Alemanya))
Mauquoi, Celine (IDDI)
Vera, C. (IVIDATA)
Bonnemaire, M. (Sanofi)
Freemantle, Nick (University College London)
Universitat Autònoma de Barcelona

Date: 2025
Abstract: To evaluate the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) initiation according to diabetes duration (DD). We analysed patient-level data from 2381 insulin-naïve individuals with type 2 diabetes (T2D), of whom 2349 (98. 7%) were treated with Gla-300 for 24 weeks. Of the 2381 participants, 1048 (44. 0%) had a DD of less than 8 years and 1333 (56. 0%) had a DD of 8 years or longer. We further analysed the subgroups of participants having a DD of less than 4 years (N = 450), 4-8 years (N = 598), 8-12 years (N = 627) and 12 years or longer (N = 706). Mean ± standard deviation age was 60. 2 ± 9. 0 years in participants with a DD less than 8 years and 64. 2 ± 8. 8 years in those with a DD of 8 years or longer. At 24 weeks of Gla-300 therapy, HbA1c improved with a least-squares (LS) mean change from baseline of -1. 88% (95% confidence interval [CI], -1. 95 to -1. 80) and -1. 71% (95% CI, -1. 77 to -1. 65), respectively, resulting in a LS mean difference between groups of 0. 17% (95% CI, 0. 07 to 0. 26; P =. 0005). In the subgroup analysis, LS mean HbA1c reduction from baseline to week 24 was highest in participants with a DD of less than 4 years and lowest in participants with a DD of 12 years or longer. Overall, incidences of symptomatic and severe hypoglycaemia were low, irrespective of DD, without body weight changes. Gla-300 was effective and safe in insulin-naïve individuals with T2D, regardless of DD. Improvement in HbA1c was greater when Gla-300 was initiated in participants with a DD of less than 4 years, although the difference between the groups was modest.
Rights: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. Creative Commons
Language: Anglès
Document: Article ; recerca ; Versió publicada
Subject: Gla-300 ; Diabetes duration ; Insulin glargine 300 U/mL ; Insuline-naïve ; Type 2 diabetes
Published in: Diabetes, Obesity and Metabolism, Vol. 27 Núm. 1 (january 2025) , p. 228-237, ISSN 1463-1326

DOI: 10.1111/dom.16008
PMID: 39420531


10 p, 1.4 MB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles

 Record created 2025-03-10, last modified 2025-10-12



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