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Positive results from S-A diabetes trial

Sanofi-aventis has announced positive results from a phase III efficacy trial of once-daily lixisenatide versus twice-daily exenatide
Sanofi-aventis (S-A) has announced that results from a phase III trial comparing two GLP-1 receptor agonists in patients with type 2 diabetes showed once-daily lixisenatide achieved primary efficacy endpoint versus twice-daily exenatide. Early data also showed that that significantly fewer people with type 2 diabetes treated with lixisenatide once-daily reported hypoglycaemic events versus patients treated with exenatide. The study was measuring both lixisenatide and exenatide as add-on therapies for patients with type 2 diabetes whose condition is inadequately controlled by metformin.

Other endpoints measured during the GetGoal-X study were broadly consistent with what has been observed with other GLP-1 agonists. 

"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 hypoglycaemia profile," said Dr Andrew Hockey, director of medical operations, sanofi-aventis, UK.

"The lixisenatide clinical development programme exemplifies our commitment to people with diabetes and our ambition to help them manage their condition more effectively," he continued.

In April 2010, S-A reported positive results when lixisenatide was compared to placebo

Lixenatide was originally developed by Zealand Pharma who out-licensed the drug to S-A on a global basis in 2003, making S-A responsible for all further clinical development of the drug. In June 2010, the licensing deal was extended to see S-A take on the development and commercialisation of Lixisenatide in combination with Lantus (insulin glargine). Lantus is a recombinant human insulin analogue and was S-A's best selling treatment in 2009 with net sales of over €3bn. 


7th February 2011


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