Glycaemic benefit of iGlarLixi in insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial.


Journal

Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645

Informations de publication

Date de publication:
08 2019
Historique:
received: 10 04 2019
revised: 17 05 2019
accepted: 20 05 2019
pubmed: 28 5 2019
medline: 17 9 2020
entrez: 25 5 2019
Statut: ppublish

Résumé

In this post hoc analysis of the randomized controlled LixiLan-O trial in insulin-naive patients with type 2 diabetes mellitus (T2DM) not controlled with metformin, with or without a second oral antihyperglycaemic drug (OAD), the efficacy and safety of the fixed-ratio combination, iGlarLixi (insulin glargine 100 U [iGlar] and lixisenatide [Lixi]), compared to its individual components was assessed in two patient subgroups: group 1) baseline HbA1c ≥9% (n = 134); group 2) inadequate control (HbA1c ≥7.0% and ≤9.0%) despite administration of two OADs at screening (n = 725). Treatment with iGlarLixi resulted in significantly greater reduction in least squares mean HbA1c compared to treatment with iGlar or Lixi alone in both subgroups (group 1: 2.9%, 2.5%, 1.7% and group 2: 1.5%, 1.2%, 0.7%, respectively). Target HbA1c less than 7% was achieved in more than 70% of patients using iGlarLixi in both subgroups, while mitigating the weight gain observed with use of iGlar alone. Rates of hypoglycaemic events were low overall. These results suggest that treatment with iGlarLixi achieves superior glycaemic control compared to treatment with iGlar or Lixi alone in T2DM patients with HbA1c ≥9% or in those inadequately controlled with two OADs.

Identifiants

pubmed: 31124299
doi: 10.1111/dom.13791
pmc: PMC6772132
doi:

Substances chimiques

Blood Glucose 0
Glycated Hemoglobin A 0
Hypoglycemic Agents 0
Peptides 0
hemoglobin A1c protein, human 0
Insulin Glargine 2ZM8CX04RZ
lixisenatide 74O62BB01U

Banques de données

ClinicalTrials.gov
['NCT02058147']

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

1967-1972

Informations de copyright

© 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Références

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pubmed: 31124299
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pubmed: 30653994

Auteurs

Melanie J Davies (MJ)

Department of Health Services, Diabetes Research Centre, University of Leicester, Leicester General Hospital and University Hospitals of Leicester NHS Trust, Leicester, UK.

David Russell-Jones (D)

Department of Diabetes and Endocrinology, University of Surrey, Guildford, UK.

Thomas M Barber (TM)

Translational Medicine, Warwick Medical School, University of Warwick, Coventry, UK.

Fernando J Lavalle-González (FJ)

Department of Endocrinology, Hospital Universitario "Dr. José Eleuterio González", Monterrey, Mexico.

Gagik R Galstyan (GR)

Diabetic Foot Department, Endocrinology Research Center, Moscow, Russia.

Dalong Zhu (D)

Department of Endocrinology, Affiliated Drum Tower Hospital, Nanjing University Medical School, Nanjing, China.

Mike Baxter (M)

Sanofi, Guildford, UK.

Cecile Dessapt-Baradez (C)

Sanofi, Guildford, UK.

Rory J McCrimmon (RJ)

Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, UK.

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