Glycaemic Control with Insulin Glargine 300 U/mL in Individuals with Type 2 Diabetes and Chronic Kidney Disease : A REALI European Pooled Data Analysis
Mauricio Puente, Dídac (Institut d'Investigació Biomèdica Sant Pau)
Gourdy, P. (Institute of Metabolic and Cardiovascular Diseases. UMR1048 INSERM/UPS. Toulouse University)
Bonadonna, Riccardo C (Department of Medicine and Surgery. University of Parma)
Freemantle, N. (Institute of Clinical Trials and Methodology. University College London)
Bigot, Gregory (IVIDATA)
Mauquoi, C. (IDDI)
Ciocca, A. (General Medicines. Sanofi)
Bonnemaire, Mireille (General Medicines. Sanofi)
Müller-Wieland, D. (Department of Medicine I. University Hospital Aachen)

Fecha:	2021
Resumen:	Introduction: Management of type 2 diabetes mellitus (T2DM) in patients with chronic kidney disease is complex. Using the REALI European pooled database, we determined the impact of baseline renal function on the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) initiated in adults with inadequately controlled T2DM. Methods: Data from 1712 patients with available estimated glomerular filtration rate (eGFR) at baseline were pooled from six 24-week prospective studies. Patients who received once-daily subcutaneous injections of Gla-300 were classified into four renal function subgroups, according to baseline eGFR: ≥ 90 (N = 599), 60-89 (N = 786), 45-59 (N = 219), and 15-44 mL/min/1. 73 m (N = 108). Results: Compared to those with baseline eGFR ≥ 60 mL/min/1. 73 m, patients with lower eGFR values tended to be older, had a longer T2DM duration, and were more likely to present diabetic complications. After 24 weeks of Gla-300 therapy, the least-squares mean (95% confidence interval) decrease in haemoglobin A1c (HbA1c) from baseline (− 1. 14% [− 1. 28 to − 1. 00], − 1. 21% [− 1. 34 to − 1. 08], − 1. 19% [− 1. 36 to − 1. 01], and − 0. 99% [− 1. 22 to − 0. 76]) and the proportion of patients achieving HbA1c < 7. 5% (53. 3%, 51. 3%, 49. 5%, and 51. 5%) were comparable in the ≥ 90, 60-89, 45-59, and 15-44 mL/min/1. 73 m subgroups, respectively. Although the incidence of hypoglycaemia was overall low, more patients in the eGFR 15-44 mL/min/1. 73 m subgroup experienced hypoglycaemia at night or at any time of the day compared with higher eGFR subgroups. There were no notable differences between the renal function subgroups in the changes in Gla-300 daily dose and body weight from baseline to week 24. Conclusion: Although an eGFR of 15-44 mL/min/1. 73 m was associated with a slightly increased risk of hypoglycaemia among patients with inadequately controlled T2DM, Gla-300 provided glycaemic improvement with an overall favourable safety profile regardless of baseline eGFR.
Nota:	Altres ajuts: Sanofi (Paris, France)
Derechos:	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.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Chronic kidney disease ; Estimated glomerular filtration rate ; Europe ; Insulin glargine 300 U/mL ; Pooled analysis ; Type 2 diabetes
Publicado en:	Diabetes Therapy, Vol. 12 Núm. 4 (april 2021) , p. 1159-1174, ISSN 1869-6961

DOI: 10.1007/s13300-021-01031-z
PMID: 33751403

16 p, 628.4 KB

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