Lixisenatide Significantly Reduces HbA1c Without Increasing Hypoglycemia in Patients Uncontrolled on Sulfonylureas

sanofi-aventisSanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that lixisenatide, a once-daily GLP-1 receptor agonist under development for people with Type 2 diabetes, achieved its primary efficacy objective of significant HbA1c reduction and improved glycemic control from baseline versus placebo. The top-line results also showed that people treated with lixisenatide had a significant decrease in body weight.

The GetGoal-S trial, one of nine studies in the GetGoal Phase III clinical program, investigated the efficacy and safety of lixisenatide as an add-on therapy for people with Type 2 diabetes whose condition was inadequately controlled by sulfonylureas, with or without metformin. GetGoal-S was a randomized (double-blind), placebo-controlled study with a 24-week main treatment period. A total of 859 patients were randomized to receive either lixisenatide or placebo. Both groups received a step-wise increase in dose, up to a maintenance dose of 20μg daily.

Top-line results of the GetGoal-S study showed that people in the lixisenatide group experienced a significant reduction in their HbA1c levels, with a -0.74% difference versus placebo (p<0.0001) at week 24. Lixisenatide also significantly improved patients' 2-hour post-prandial glucose (p<0.0001) and fasting plasma glucose (p<0.0001) levels. In addition, people treated with lixisenatide had a significant decrease in body weight (p<0.0001), versus those receiving placebo.

Results from GetGoal-S also showed that lixisenatide did not significantly increase the risk of symptomatic hypoglycemia at week 24 (p=0.23), compared with placebo.

"The results of GetGoal-S are another positive step for lixisenatide and reinforce the efficacy and safety profile of this new GLP-1," said Pierre Chancel, Senior Vice President, Global Diabetes Division, sanofi-aventis. "The demonstration of benefits in terms of improving glycemic control and reducing body weight in this population, without significantly increasing the risk of symptomatic hypoglycemia, confirmed that lixisenatide is a potential important new therapy in Type 2 diabetes to help people manage their condition more effectively."

The full study findings are planned to be presented at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting, in September 2011.

About Lixisenatide (AVE 0010)
Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with Type 2 diabetes mellitus. Lixisenatide was in-licensed from Zealand Pharma A/S (Copenhagen, Denmark).

GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for Type 2 diabetes and their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology.

About the GetGoal Phase III Clinical Program
The GetGoal Phase III clinical program is providing expanding evidence for the efficacy and safety of lixisenatide in adults with Type 2 diabetes treated with various oral anti-diabetic agents or insulin. With nine trials in the program, GetGoal started in May 2008 and has enrolled more than 4300 patients. To date GetGoal-X, GetGoal-Mono and GetGoal-L Asia have reported positive top-line results supporting efficacy and safety for lixisenatide. Further results are expected during 2011.

About the sanofi-aventis Diabetes Division
Sanofi-aventis strives to deliver innovative and integrated patient-focused solutions for people living with diabetes. The Company currently has insulin products that are also available in injection pens for people with Type 1 or Type 2 diabetes, as well as an oral, once-daily sulfonylurea treatment for Type 2 diabetes. In order to provide comprehensive care in diabetes management, sanofi-aventis also provides innovative blood glucose monitoring systems. Investigational compounds in the pipeline include the potential first regenerative treatment for diabetes as well as a once-daily injectable GLP-1 agonist to be used alone, in combination with basal insulins, and/or in combination with oral anti-diabetic agents.

About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).