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Sanofi reveals successful Lyxumia studies

Sanofi reports successful phase III trial results for diabetes treatment Lyxumia

Sanofi's investigational product Lyxumia (lixisenatide) has achieved its primary efficacy endpoint of significantly reducing HbA1c for patients with type 2 diabetes without significantly increasing their risk of hypoglycaemia, when used as an add-on therapy to basal insulin (in association with or without metformin).

GetGoal-L is one of nine studies in the GetGoal phase III clinical programme, and the second trial to investigate the benefits of lixisenatide 20µg once-daily combined with basal insulin. It was a randomised (double-blind), placebo-controlled study with a 24-week main treatment period, and a total of 495 patients received either lixisenatide or placebo.

GetGoal-L showed a significant reduction in HbA1c levels with lixisenatide, without a significant increase in the incidence of symptomatic hypoglycaemia versus placebo. In addition, patients treated with lixisenatide had significantly improved postprandial plasma glucose after a test meal. Patients in the lixisenatide arm of the study also reported a significant reduction in body weight.

Professor A H Barnett, professor of medicine and clinical director at Heartlands Hospital, Birmingham, UK, said: "These results are encouraging and highlight the potential value of adding lixisenatide to basal insulin to improve glycaemic control. They are another important milestone in the GetGoal clinical trial programme and the findings from the programme so far suggest that lixisenatide has the potential to be an important new therapy for patients with type 2 diabetes."

The results confirm those reported on GetGoal-L Asia, this time in a broader population including both Caucasian and Asian patients. As expected with a GLP-1, the most commonly reported adverse side effect with lixisenatide was nausea with a low rate of discontinuation.

6th June 2011

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