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Trial success for S-A's diabetes drug

Sanofi-aventis has announced promising results of a phase III study involving diabetes drug, lixisenatide

Sanofi-aventis (S-A) has announced promising results of a phase III study involving diabetes drug, lixisenatide (AVE0010).

The drug is a once daily GLP-1 agonist, meaning it can combine with a receptor on a cell to produce a physiological reaction. It was found that, when compared with a placebo, lixisenatide improved glycemic control in adult patients with type 2 diabetes, and significantly reduced results of HbA1c – a test that measures average blood glucose levels over a two- to three-month period.

Speaking on the results, Dr Marc Cluzel, executive vice-president of R&D at S-A said: "Developing new diabetes treatments, like lixisenatide, and helping patients achieve diabetes control is paramount to tackling the growing diabetes epidemic. We are pleased with the top-line results from our first phase III study of this novel, once-daily GLP-1 agonist and are looking forward to sharing the full results later in the year."

The findings of the study, which was part of S-A's GetGoal phase III clinical trial programme, have been submitted for presentation at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD), in Stockholm, Sweden, in September 2010.

Commencing in May 2008, the GetGoal programme has involved over 4,500 patients in several trials. This particular study saw 361 patients with type 2 diabetes who were currently not receiving therapy to lower glucose levels, and had an HbA1c rating between 7 and 10 per cent. These patients were then randomised into four groups, each receiving different dosages of lixisenatide or a placebo.

Significantly more patients (46.5 to 52.2 per cent compared to 26.8 per cent) who were in the lixisenatide groups achieved a HbA1c of less than 7 per cent against the placebo group. Less than 7 per cent HbA1c is the blood sugar control target recommended by the American Diabetes Association.

The drug was also well-tolerated, with only minor side-effects, including nausea.

Lixisenatide was initially developed by Zealand Pharma, before S-A purchased the license to the drug.

Speaking on the recent trial results, David Solomon, CEO and president of Zealand Pharma said: "We are delighted to note today's announcement from our strong partner, sanofi-aventis, regarding the first successful phase III results from the GetGoal study for lixisenatide. These results represent a significant achievement for Zealand Pharma, and for patients with type 2 diabetes.

"We look forward to the ongoing clinical development of lixisenatide by sanofi-aventis and are extremely excited about the future initiation of new phase III studies of lixisenatide in combination with Lantus which are expected to commence later this year."

15th April 2010

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