Benefit of insulin glargine/lixisenatide for reducing residual hyperglycaemia in Japan: Post hoc analysis of the LixiLan JP-O2 trial

Aim: To compare the benefits of iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi), with insulin glargine (iGlar) for reducing residual hyperglycaemia (defined as HbA1c ≥ 7% despite fasting plasma glucose [FPG] < 130 mg/dL) in Japanese people with type 2 diabetes (T2D) inadequately controlled on oral antidiabetic drugs. Materials and Methods: The open-label LixiLan JP-O2 study compared iGlarLixi with iGlar over 26 weeks in 521 people with T2D. This post hoc analysis assessed the proportions of participants with residual hyperglycaemia in the overall population, and in subgroups defined by age and dipeptidyl peptidase-4 inhibitor (DPP4i) use at screening. Results: At 26 weeks, significantly fewer participants had residual hyperglycaemia in the iGlarLixi versus the iGlar arm (8.1% vs. 19.6%; P =.0002). There was also less residual hyperglycaemia with iGlarLixi than iGlar in all subgroup analyses: 9.0% versus 16.8% in participants aged younger than 65 years (P =.0369); 6.5% versus 24.2% in participants aged 65 years or older (P =.0008); 10.1% versus 20.5% (P =.0202) in participants with DPP4i use; and 6.2% versus 18.8% in those without DPP4i use (P =.0024). The proportion reaching both HbA1c less than 7% and FPG less than 130 mg/dL was higher with iGlarLixi versus iGlar in the overall population (50.8% vs. 31.5%; P <.0001), and in all studied subgroups. Conclusions: iGlarLixi reduced the prevalence of residual hyperglycaemia in Japanese people with uncontrolled T2D compared with iGlar, both in the overall population and in subgroups defined by age and DPP4i use at screening.