Consistent glycaemic efficacy and safety of concomitant use of iGlarLixi and sodium-glucose co-transporter-2 inhibitor therapy for type 2 diabetes: A patient-level pooled analysis of three randomised clinical trials.

Autor: Giorgino F; Department of Precision and Regenerative Medicine and Ionian Area, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro, Bari 70124, Italy. Electronic address: francesco.giorgino@uniba.it., Guja C; Department of Diabetes, Nutrition and Metabolic Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest 030167, Romania. Electronic address: cristian.guja@hotmail.com., Aydın H; Department of Endocrinology, Yeditepe University School of Medicine, Istanbul 34724, Turkey. Electronic address: hsnydn@yahoo.com., Lauand F; Sanofi, Paris 75017, France. Electronic address: felipe.lauand@sanofi.com., Melas-Melt L; Ividata Life Sciences, Levallois-Perret 92300, France. Electronic address: lydie.melas-melt-ext@sanofi.com., Rosenstock J; Velocity Clinical Research at Medical City, 75230 Dallas, TX, USA. Electronic address: jrosenstock@velocityclinical.com.
Jazyk: angličtina
Zdroj: Diabetes research and clinical practice [Diabetes Res Clin Pract] 2024 Mar; Vol. 209, pp. 111604. Date of Electronic Publication: 2024 Mar 05.
DOI: 10.1016/j.diabres.2024.111604
Abstrakt: Aims: Sodium glucose co-transporter 2 inhibitors (SGLT2is) and/or glucagon-like peptide-1 receptor agonists (GLP-1 RAs) with proven cardio- and reno-protective benefits are recommended in people with type 2 diabetes (T2D) at high risk of cardiovascular disease, chronic kidney disease, and/or heart failure. This pooled analysis compared efficacy and safety outcomes of iGlarLixi with or without SGLT2is in people with T2D.
Methods: This post hoc analysis evaluated outcomes in participants who were receiving an SGLT2i when initiating iGlarLixi (SGLT2i users) and those who were not (SGLT2i non-users) in a pooled dataset from three trials: LixiLan-G (advancing from a GLP-1 RA), SoliMix and LixiLan ONE CAN (advancing from basal insulin).
Results: Baseline characteristics were generally similar between 219 users and 746 non-users. Least squares mean changes in HbA 1c from baseline to Week 26 were similar for users (-1.2 % [95 % confidence intervals: -1.4 %, -1.1 %]) and non-users (-1.2 % [-1.2 %, -1.1 %]). Changes in body weight, fasting glucose and post-prandial glucose were similar between groups, as were hypoglycaemic events.
Conclusions: Pooled results from three studies of adults with T2D demonstrated that iGlarLixi provided similar clinically meaningful improvements in glycaemic control without increased hypoglycaemia risk, regardless of concomitant use of SGLT2is.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: FG: has served as an advisor for Eli Lilly, Medtronic, Novo Nordisk, Roche Diabetes Care and Sanofi; has received payment of honoraria for lectures, presentations, manuscript writing or education events from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medtronic, Novo Nordisk, Roche Diabetes Care and Sanofi; has patents planned, issued or pending for Roche Diabetes Care; has served as a research investigator for Eli Lilly, Novo Nordisk and Roche Diabetes Care, and has received grants from Eli Lilly and Roche Diabetes Care. CG: has participated in scientific advisory boards for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk and Sanofi and has received consulting fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Krka, Merck KGaA, MSD, Novo Nordisk, Sanofi and Servier. HA: Nothing to disclose. FL is an employee of Sanofi; may hold shares and/or stock options. LMM: Employee of Ividata Life Sciences, Levallois-Perret, France, contracted by Sanofi. JR has served on advisory panels for Applied Therapeutics, Boehringer Ingelheim, Eli Lilly, Hanmi, Intarcia, Novo Nordisk, Oramed, Sanofi, Structure Therapeutics, Terns Pharma and Zealand, and has received research support from Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Intarcia, Merck, Novo Nordisk, Oramed, Pfizer and Sanofi.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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