Does Gender Influence the Effectiveness and Safety of Insulin Glargine 300 U/ml in Patients with Uncontrolled Type 2 Diabetes? Results from the REALI European Pooled Analysis
Gourdy, Pierre (Université de Toulouse)
Bonadonna, Riccardo C. (University of Parma)
Freemantle, Nick (University College London)
Mauricio Puente, Dídac (Institut d'Investigació Biomèdica Sant Pau)
Müller-Wieland, Dirk (University Hospital Aachen (Alemanya))
Bigot, Gregory (IVIDATA)
Mauquoi, Celine (IDDI)
Ciocca, Alice (General Medicines. Sanofi)
Bonnemaire, Mireille (General Medicines. Sanofi)

Date:	2022
Abstract:	Introduction: Gender differences in risk factors and treatment outcomes for type 2 diabetes mellitus (T2DM) may exist. We used the REALI European database to investigate whether there were gender-specific differences in baseline characteristics and clinical outcomes among patients with inadequately controlled T2DM initiated on insulin glargine 300 U/ml (Gla-300). Methods: Data were pooled from 14 multicentre, prospective, interventional and non-interventional studies. Impact of gender on glycaemic control, insulin dose, body weight and hypoglycaemia was evaluated after 12 and 24 weeks of Gla-300 treatment. Results: Women (N = 3857) were older than men (N = 4376) (median age, 65. 0 versus 63. 0 years), with greater mean body mass index (32. 5 versus 31. 6 kg/m) and lower median estimated glomerular filtration rate (77. 5 versus 84. 0 ml/min/1. 73 m). Peripheral arterial disease and a history of myocardial infarction were more frequent in men (20. 1% versus 11. 7% and 12. 0% versus 5. 8%, respectively). At baseline, mean haemoglobin A1c (HbA1c) was 8. 74% in men and 8. 79% in women. Least square (LS) mean (95% CI) reduction in HbA1c from baseline to week 24 was − 1. 17% (− 1. 21 to − 1. 13) in men and − 1. 07% (− 1. 11 to − 1. 02) in women, resulting in a LS mean difference of − 0. 10% (− 0. 15 to − 0. 05; p < 0. 0001). At 24 weeks, 21. 6% of women and 27. 2% of men achieved target HbA1c of < 7. 0% (p < 0. 001; chi-square). Reported incidence for symptomatic (8. 5% versus 8. 7%) and severe (0. 3% versus 0. 5%) any-time-of-the-day or symptomatic (2. 4% versus 1. 8%) and severe (0. 1% versus 0. 2%) nocturnal hypoglycaemia was overall low and comparable between men and women. Changes in daily Gla-300 dose and body weight were also similar. Conclusion: Despite some gender differences in baseline characteristics, Gla-300 treatment improved glycaemic control, with overall low hypoglycaemia incidences in both men and women. However, women had statistically significantly lower HbA1c reductions than men, although these differences were clinically modest.
Note:	Altres ajuts: Sanofi (Paris, France).
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Europe ; Gender differences ; Glycaemic control ; Insulin glargine 300 U/ml ; Pooled analysis ; Type 2 diabetes
Published in:	Diabetes Therapy, Vol. 13 Núm. 1 (january 2022) , p. 57-73, ISSN 1869-6961

DOI: 10.1007/s13300-021-01179-8
PMID: 34784005

17 p, 389.2 KB

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