Positive top-line phase III data in type 2 diabetes achieved for lixisenatide once-daily vs. exenatide twice-daily
Lixisenatide meets primary efficacy endpoint with fewer hypoglycaemias
Zealand Pharma A/S announced that its partner, sanofi-aventis, announced that the GetGoal-X Phase III study of lixisenatide, a once-daily GLP-1 receptor agonist licensed from Zealand Pharma, achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline, compared with exenatide twice-daily.
In addition, the initial results showed that significantly fewer people with type 2 diabetes treated with lixisenatide once-daily reported hypoglycemic events versus patients treated with exenatide. In the lixisenatide arm three-fold fewer people reported symptomatic hypoglycemia than people who were on exenatide (2.5% vs. 7.9%; p<0.05). Six-fold fewer hypoglycemia events were observed in patients on lixisenatide than those treated with exenatide (8 vs. 48 events). Other endpoints were broadly consistent with what has been observed with other GLP-1 agonists.
The GetGoal-X clinical trial is a randomized, open-label, active-controlled, two-arm parallel-group, multicenter study, with a 24-week main treatment period. It compared the efficacy and safety of the two GLP-1 receptor agonists: once-daily lixisenatide vs. twice-daily exenatide as add-on therapy for people with type 2 diabetes whose condition is inadequately controlled by metformin. A total of 639 people were randomized to receive either lixisenatide or exenatide. Both groups received a stepwise increase in dose, up to a maximum daily dose of 20µg.
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