Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L Randomized Clinical Trial.

To assess efficacy and safety of fixed-ratio (1:1) combination insulin glargine and lixisenatide (iGlarLixi) compared to insulin glargine U100 (iGlar), with metformin, in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin and oral antidiabetic drugs (OADs).This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs. 512 patients were randomized after a 12-week run-in, when iGlar was introduced and/or further titrated and OADs other than metformin were stopped. The primary endpoint was change in HbA1c from baseline to week 26.iGlarLixi (n=255) demonstrated significantly greater reductions in HbA1c (-1.27%) than iGlar (n=257, -0.53%) (LS mean difference: -0.74%, P <0.0001) at week 26, confirming the superiority of iGlarLixi. Significantly more iGlarLixi patients reached target HbA1c <7% at week 26 (51.8% vs. 16.0% for iGlar). iGlarLixi patients lost weight in contrast to iGlar patients (-0.51kg vs. +0.55kg). Documented symptomatic hypoglycemia (plasma glucose ≤3.9mmol/L) was observed in 18.8% of iGlarLixi patients vs. 16.7% of iGlar patients. iGlarLixi patients had more gastrointestinal-related adverse events than iGlar patients (33.3% vs. 8.6%), primarily nausea (16.9% vs. 0.8%). However, the treatment was generally well-tolerated.A once-daily injection of iGlarLixi with metformin is an effective, well-tolerated, and simple therapeutic intervention providing significant improvement in glycemic control in Japanese patients with T2DM inadequately controlled on basal insulin and up to two OADs. Clinical Trial Number: NCT02752412 This article is protected by copyright. All rights reserved.