What are the benefits of lixisenatide (Adlyxin) in the treatment of type 2 diabetes mellitus (DM) and how should it be used?

Updated: Jul 13, 2021
  • Author: Romesh Khardori, MD, PhD, FACP; Chief Editor: George T Griffing, MD  more...
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Lixisenatide (Adlyxin) was approved by the FDA in July 2016 as adjunctive therapy to diet and exercise to improve glycemic control in type 2 diabetes mellitus. It is administered by subcutaneous injection once daily within 1 hour before the first meal of the day. The starting dose is 10 mcg/day SC for 14 days and is then increased on day 15 to 20 mcg once daily.

The FDA approved lixisenatide based on results from the GetGoal worldwide clinical program and from the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trials. [219, 220, 221]

The drug's safety and efficacy was assessed by the GetGoal program, which included 13 clinical trials of adults with type 2 diabetes mellitus (n >5000). The primary efficacy endpoint, HbA1c reduction, was achieved by all of the GetGoal studies. [219, 220]

The ELIXA study demonstrated that in patients with type 2 diabetes who had had a recent acute coronary syndrome, cardiovascular adverse events did not increase in those taking lixisenatide compared with patients taking placebo. The study included 6068 adults with type 2 diabetes, 39% of whom had a recent non–ST-segment-elevation myocardial infarction, 43% of whom had ST-segment-elevation myocardial infarction, and 17% of whom had unstable angina. At a median of 25 months, the investigators found that cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina had occurred in 13.4% of the lixisenatide patients and 13.2% of the control patients. [221]

A study to assess efficacy and safety of lixisenatide monotherapy in type 2 diabetes found a once-daily dose of the drug improved glycemic control. Once-daily monotherapy significantly lowered postprandial glucose and was well tolerated by patients with type 2 diabetes. [222]

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