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Efficacy and safety of 1:1 fixed-ratio combination of insulin glargine and lixisenatide vs lixisenatide in Japanese patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs: The LixiLan JP-O1 randomized clinical trial

Diabetes Care May 03, 2020

Watada H, Takami A, Spranger R, et al. - Researchers conducted this phase 3, open-label, multicenter trial to test the safety and effectiveness of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) vs lixisenatide (Lixi) in insulin-naïve Japanese individuals with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs). Three hundred twenty-one individuals with HbA1c ≥ 7.5 to ≤ 10.0% (58–86 mmol/mol) and fasting plasma glucose ≤ 13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The data presented in this work showed better glycemic control and less gastrointestinal adverse effects with iGlarLixi than with Lixi, which may support it as a potential treatment choice for Japanese T2DM patients who are inadequately controlled with OADs.

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