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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.

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posted on 2019-06-03, 13:02 authored by MJ Davies, D Russell-Jones, TM Barber, FJ Lavalle-González, GR Galstyan, D Zhu, M Baxter, C Dessapt-Baradez, RJ McCrimmon
In this post hoc analysis of the randomized controlled LixiLan-O trial in insulin-naive type 2 diabetes mellitus (T2DM) patients not controlled on 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: (1) a baseline HbA1c ≥9% (n = 134); (2) inadequate control (HbA1c ≥7.0% and ≤9.0%) despite administration of two OADs at screening (n = 725). Treatment with iGlarLixi resulted in a significantly greater reduction in least squares mean HbA1c compared with iGlar or Lixi alone in both subgroups (HbA1c ≥9% group: 2.9%, 2.5%, 1.7%; two OADs group: 1.5%, 1.2%, 0.7%, respectively). Target HbA1c <7% was achieved in >70% of patients on iGlarLixi in both subgroups, while mitigating the weight gain observed with iGlar alone. Rates of hypoglycaemic events were low overall. These results suggest that iGlarLixi achieves superior glycaemic control compared with iGlar or Lixi alone in T2DM patients with HbA1c ≥9% or those inadequately controlled on two OADs.

Funding

The LixiLan-O trial (NCT02058147) and this post hoc analysis was sponsored by Sanofi. The authors thank the study participants, trial staff, and investigators for their participation. The authors also thank Minzhi Liu and Yao Huang at BDM Consulting Inc. for performing the statistical analyses. MJD wishes to thank the National Institute of Health Research Leicester Biomedical Research Centre for supporting the research. Coordination of the development of this manuscript and assistance with the revision was provided by Helena Andersson, PhD, at Sanofi. Professional medical writing and editorial assistance was provided by Christina Holleywood, PhD, and Catriona McKay, PhD, at Caudex, and was funded by Sanofi.

History

Citation

Diabetes, Obesity and Metabolism, 2019

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Diabetes Research Centre

Version

  • AM (Accepted Manuscript)

Published in

Diabetes

Publisher

Wiley

eissn

1463-1326

Acceptance date

2019-05-20

Copyright date

2019

Publisher version

https://onlinelibrary.wiley.com/doi/abs/10.1111/dom.13791

Notes

The file associated with this record is under embargo until 12 months after publication, in accordance with the publisher's self-archiving policy. The full text may be available through the publisher links provided above.;Qualified researchers may request access to patient-level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com.

Language

en

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