Real-world effectiveness and safety of insulin glargine 100 U/mL plus lixisenatide in adults with type 2 diabetes: An international, multicentre, 12-month, prospective observational study.

Autor: Malik RA; Research Division, Weill Cornell Medicine-Qatar, Qatar Foundation, Education City, Qatar., Hwu CM; Section of Endocrinology and Metabolism, Taipei Veterans General Hospital, Taipei, Taiwan., Jammah AA; Endocrinology and DM Division, Department of Medicine, King Saud University, King Saud University Medical City, Riyadh, Saudi Arabia., Arteaga-Díaz JM; Division of Endocrinology, Department of Internal Medicine, School of Medicine, Universidad Nacional de Colombia, Bogotá, Colombia., Djaballah K; Sanofi, Paris, France., Pilorget V; Sanofi, Paris, France., Alvarez A; Sanofi, Madrid, Spain., Vera C; Ividata Life Sciences, Levallois-Perret, France., Vikulova O; Endocrinology Research Centre, Moscow, Russian Federation.
Jazyk: angličtina
Zdroj: Diabetes, obesity & metabolism [Diabetes Obes Metab] 2024 Jul; Vol. 26 (7), pp. 2811-2819. Date of Electronic Publication: 2024 Apr 18.
DOI: 10.1111/dom.15599
Abstrakt: Aim: To assess the impact of insulin glargine (100 U/mL) and lixisenatide (iGlarLixi) fixed-ratio combination therapy on the overall management of glycaemia in patients with type 2 diabetes (T2D), previously inadequately controlled with oral antidiabetic drugs ± basal insulin or glucagon-like peptide-1 receptor agonists (GLP-1 RAs).
Materials and Methods: This 12-month, international, multicentre, prospective, observational study included patients (age ≥ 18 years) with T2D who had initiated iGlarLixi within 1 month prior to study inclusion. Data were collected at study inclusion, month 3, month 6 and month 12 from patient diaries, self-measured plasma glucose, and questionnaires. The primary endpoint was change in HbA1c from baseline to month 6.
Results: Of the 737 eligible participants (mean age: 57.8 [standard deviation: 11.2] years; male: 49%), 685 had baseline and post-baseline HbA1c data available. The least squares mean change in HbA1c from baseline to month 6 was -1.4% (standard error [95% confidence interval (CI)]: 0.05 [-1.5, -1.3]). The absolute change from baseline at month 12 was -1.7% ± 1.9% (95% CI: -1.9, -1.5). There were 72 hypoglycaemia events reported during the study period, with a very low incidence of severe hypoglycaemia (two participants [rate: 0.003 events per patient-year]).
Conclusions: This real-world observational study shows that initiation of iGlarLixi in people with T2D inadequately controlled on oral antidiabetic drugs ± basal insulin or GLP-1 RAs improves glycaemic control with a low incidence of hypoglycaemia.
(© 2024 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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