Efficacy and safety of insulin glargine/lixisenatide (iGlarLixi) fixed-ratio combination in older adults with type 2 diabetes.


Journal

Journal of diabetes and its complications
ISSN: 1873-460X
Titre abrégé: J Diabetes Complications
Pays: United States
ID NLM: 9204583

Informations de publication

Date de publication:
03 2019
Historique:
received: 22 06 2018
revised: 02 11 2018
accepted: 23 11 2018
pubmed: 3 1 2019
medline: 3 7 2020
entrez: 3 1 2019
Statut: ppublish

Résumé

This study assessed the efficacy and safety of iGlarLixi (a titratable, fixed-ratio combination of insulin glargine [iGlar] plus lixisenatide) in older patients with type 2 diabetes. This post hoc analysis used patient-level data from patients aged ≥65 years from the phase III LixiLan-O and LixiLan-L studies, which compared iGlarLixi with iGlar and lixisenatide (LixiLan-O only). Efficacy endpoints were changes in glycated hemoglobin A1C, fasting plasma glucose, postprandial glucose, weight, and achievement of A1C <7.0% (53 mmol/mol). Safety measures included incidence of documented symptomatic hypoglycemia (defined as typical symptoms of hypoglycemia plus self-measured plasma glucose ≤70 mg/dL [3.9 mmol/L]), severe hypoglycemia (requiring assistance of another person), and incidence of gastrointestinal adverse events. Results were compared with those from patients aged <65 years. In both trials, older patients treated with iGlarLixi achieved significantly greater reductions in A1C at Week 30 than comparators. Treatment with iGlarLixi mitigated insulin-associated weight gain and lixisenatide-associated gastrointestinal events. Results were largely comparable between patients aged ≥65 versus <65 years. iGlarLixi provides significant improvements in glycemic control in patients aged ≥65 years without increasing hypoglycemia risk. As a once-daily injection, it simplifies treatment regimens and may contribute to improved adherence in this patient population.

Identifiants

pubmed: 30600136
pii: S1056-8727(18)30601-9
doi: 10.1016/j.jdiacomp.2018.11.009
pii:
doi:

Substances chimiques

Blood Glucose 0
Drug Combinations 0
Glycated Hemoglobin A 0
Hypoglycemic Agents 0
Peptides 0
Insulin Glargine 2ZM8CX04RZ
lixisenatide 74O62BB01U

Types de publication

Clinical Trial, Phase III Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

236-242

Informations de copyright

Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Auteurs

Yehuda Handelsman (Y)

Metabolic Institute of America, 18372 Clark St. Suite 212, Tarzana, CA 91356, USA. Electronic address: yhandelsman@gmail.com.

Christina Chovanes (C)

Abington Memorial Hospital, 500 York Rd Suite 108, Jenkintown, PA 19046, USA. Electronic address: cchovane@gmail.com.

Terry Dex (T)

Sanofi US, Inc., 55 Corporate Drive, Bridgewater, NJ 08807, USA. Electronic address: terry.dex@sanofi.com.

Francesco Giorgino (F)

University of Bari Aldo Moro, Piazza Giulio Cesare 11, Bari 70124, Italy. Electronic address: francesco.giorgino@uniba.it.

Neil Skolnik (N)

Abington Memorial Hospital, 500 York Rd Suite 108, Jenkintown, PA 19046, USA. Electronic address: nskolnik@comcast.net.

Elisabeth Souhami (E)

Sanofi, 1 Avenue Pierre Brossolette, 91380 Chilly-Mazarin, France. Electronic address: elisabeth.souhami@sanofi.com.

William Stager (W)

Sanofi US, Inc., 55 Corporate Drive, Bridgewater, NJ 08807, USA. Electronic address: william-EXT.stager@sanofi.com.

Elisabeth Niemoeller (E)

Sanofi Pasteur, K703, Industriepark Höchst, 65926 Frankfurt, Germany. Electronic address: elisabeth.niemoeller@sanofi.com.

Juan Pablo Frias (JP)

National Research Institute, 2010 Wilshire Blvd #302, Los Angeles, 90057, CA, USA. Electronic address: juan.frias@nritrials.com.

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Classifications MeSH