Sanofi-Aventis Diabetes Monotherapy Meets Phase III Study Endpoint Successfully

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Sanofi-aventis announced the results of the first placebo-controlled study of the GetGoal Phase III clinical trial program of lixisenatide (AVE0010), a once-daily GLP-1 agonist developed for patients with type 2 diabetes.
The 12-week study involved 361 patients with type 2 diabetes not currently receiving glucose-lowering therapy and with HbA1c between 7 and 10%. The study found HbA1c was significantly reduced in lixisenatide titration groups versus placebo, and significantly more patients in the lixisenatide groups achieved HbA1c < 7% (46.5 to 52.2% versus 26.8%). as compared to placebo. Lixisenatide also significantly improved fasting plasma glucose and two-hour post-prandial glucose with a pronounced decrease in 2-hour post-prandial glucose excursion.
A Phase III program with the combination of lixisenatide / Lantus® (insulin glargine [rDNA]injection) is expected to start later this year.

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