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news.Sanofi-aventis has said that the results of the first, placebo-controlled study of GetGoal Phase III clinical trial program showed Lixisenatide (AVE0010), a once-daily GLP-1 agonist, reduced HbA1c vs placebo with more patients achieving HbA1c
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The complete study findings 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.
Sanofi-aventis said that the 12-week study involved 361 patients with type 2 diabetes not currently receiving glucose-lowering therapy and with HbA1c between 7 and 10%. Patients were randomised to one of four once-daily treatment regimens: Lixisenatidetwo-step titration, Lixisenatideone-step titration, placebo two-step titration, or placebo one-step titration.
Baseline characteristics were similar among groups in terms of mean age (53.7 ± 10.5 years), diabetes duration (2.5 ± 3.4 years) and HbA1c (8.04 ± 0.9%). HbA1c was significantly reduced in both Lixisenatidetitration groups versus placebo, and significantly more patients in the Lixisenatidegroups achieved HbA1c < 7% (46.5 to 52.2% versus 26.8%) as compared to placebo.
Additionally, Lixisenatidealso improved fasting plasma glucose and two-hour post-prandial glucose with a pronounced decrease in 2-hour post-prandial glucose excursion.
Marc Cluzel, executive vice-president of R&D at Sanofi-aventis, 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.”