Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

Summary

Primary Objective: To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus. Secondary Objective: To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.

Timeline

Start

2016-05-17

Primary completion

2018-10-04

Completion

2018-10-04

Outcome

Met primary endpoint

paper (-1.27%) than iGlar (n = 257, -0.53%) (LS mean difference: -0.74%, P < .0001) at week 26, confirming the superiority of iGlarLixi. PMID 32072742 ↗

Publications

• Results Kaneto H, Takami A, Spranger R, Amano A, Watanabe D, Niemoeller E. 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. Diabetes Obes Metab. 2020 Sep;22 Suppl 4:3-13. doi: 10.1111/dom.14005.

Drugs

Indications