Next GLP-1 (Lixisenatide) Achieves Positive Phase III Data in Type 2 Diabetes

Zealand Pharma, a biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, is pleased to announce that its partner, sanofi-aventis, today 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 20microg. 

"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.

The full study findings will be presented by sanofi-aventis at a medical congress. 

Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with Type 2 diabetes. 

The efficacy and safety of lixisenatide once-daily is being assessed in the GetGoal Phase III clinical trial program. The GetGoal clinical trial program started in May 2008 and has enrolled more than 4,500 patients globally. Enrolment of the GetGoal Phase III program assessing efficacy and safety of lixisenatide in adult patients with Type 2 diabetes mellitus treated with various oral anti-diabetic agents or insulin was completed at the end of 2009. The next results of the GetGoal Phase III program are expected to be released in Q2 2011. 

Press Release: Sanofi-Aventis