Sanofi-aventis Announces Positive Top-line Lixisenatide Phase III Results

04-Feb-2011 - France

Sanofi-aventis announced that lixisenatide once-daily achieved primary efficacy endpoint and fewer hypoglycemias vs. exenatide twice-daily.

The GetGoal-X Phase III study of lixisenatide, a once-daily GLP-1 receptor agonist, 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.

“GetGoal-X, the first head-to-head study comparing lixisenatide with another GLP-1, demonstrates the efficacy of lixisenatide once-daily in reducing HbA1c in people with type 2 diabetes and also shows a better hypoglycemia profile,” said Pierre Chancel, Senior Vice President, Global Diabetes, sanofi-aventis.

https://www.bionity.com/en/news/130627/sanofi-aventis-announces-positive-top-line-lixisenatide-phase-iii-results.html