Zealand Pharma A/S, 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.
Commenting on today's announcement, David Solomon, President and Chief Executive Officer of Zealand Pharma, said: "We are delighted that lixisenatide achieved its primary endpoint in this first Phase III head-to-head study with a marketed GLP-1 product. This is a further confirmatory step in the development and approval path for lixisenatide, lending additional support to the drug's potential role for patients with type 2 diabetes and their care providers."
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 lixisenatide clinical development program exemplifies our commitment to people with diabetes and our ambition to help them manage their condition more effectively."
Intensive blood pressure treatment reduces cardiovascular risk in people with Type 2 diabetes