Davies_et_al-2019-Diabetes,_Obesity_and_Metabolism accepted.pdf (1.12 MB)
Download fileGlycaemic 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 contribution
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 McCrimmonIn 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, 2019Author affiliation
/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Diabetes Research CentreVersion
- AM (Accepted Manuscript)