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EASD: Positive results for Sanofi’s Lyxumia

Sanofi has published phase III trial results at the European Association for the Study of Diabetes meeting that indicate lixisenatide is effective in improving glycaemic control in type 2 diabetes patients

Sanofi has published phase III trial results at the European Association for the Study of Diabetes (EASD) meeting that indicate its investigational GLP-1 receptor lixisenatide is effective in improving glycaemic control in type 2 diabetes patients.

Lixisenatide, due to be marketed as Lyxumia if approved for use, completed its primary endpoint of significant reduction in glycated haemoglobin levels compared to placebo. Significant weight loss was also achieved in patients.

The data found that the one-step regimen of the treatment was as effective as the two-step regimen.

The study is part of Sanofi's GetGoal clinical programme, involving nine studies into the use of lixisenatide. First regulatory submissions for the products are expected in the second half of 2011 in Europe, with US Food and Drug Administration submissions expected in 2012.

The France-based pharmaceutical company also published data on its basal insulin injection Lantus that indicates early use in type 2 patients leads to better glycaemic control with fewer adverse effects and more modest weight gain compared to similar treatments.

Hypoglycaemia occurred significantly less than with comparator products.

Speaking to PMLiVE, Pierre Chancel, senior vice-president at Sanofi and head of the company's diabetes division, indicated the simplicity of the products as another advantage, with patient adherence a key issue in diabetes management.

“When a product is simple to use, it tends to enhance compliance. People can have a switch on and switch off mode when it comes to their condition.”

15th September 2011

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