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Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions
Date:6/24/2011

PARIS, June  24, 2011 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today data from four studies  of its once-daily GLP-1 receptor agonist Lyxumia® (lixisenatide) that  is in Phase III clinical development, including data that demonstrates positive results in type 2 diabetes patients not at goal on oral therapies or with  basal insulin. These data are being presented or published at the American Diabetes Association's 71st Scientific Sessions in San Diego, California.

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"Efficacy and Safety of Lixisenatide Once-Daily Versus Exenatide Twice-Daily in Type 2 Diabetes Inadequately Controlled on Metformin (GetGoal-X)" [ABSTRACT 0033-LB]"Lixisenatide once daily demonstrated efficacy in blood glucose control by meeting an endpoint of non-inferiority  at week 24 in a head-to-head study versus exenatide twice daily," said Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center at Medical City Dallas and lead investigator of the GetGoal-X trial.

In the GetGoal-X trial, a randomized, open-label, active-controlled, two-arm parallel-group, multicenter study with a 24-week main treatment period, lixisenatide once daily achieved its primary endpoint of non-inferiority in A1C reduction from baseline with less symptomatic hypoglycemia (low blood sugar) and better gastrointestinal tolerability versus exenatide twice daily, as an add-on to metformin in patients with type 2 diabetes. A total of 634 people were randomized to receive either lixisenatide or exenatide. Both groups received a stepwise increase in dose, up to a maximum daily dose of 20 microgram.  At baseline, the mean age in the trial was 57.4 years, mean diabetes duration 6.8 years, mean body mass index (BMI) 33.
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