Paris, France – September 30, 2010 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the top-line results of the GETGOAL-L-ASIA study assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, in combination with basal insulin. Results from the Phase III study showed that lixisenatide once-daily in combination with basal insulin (with or without sulfonylurea) significantly improved glycemic control. The study also confirmed that there are no specific safety concerns with lixisenatide in patients with type 2 diabetes.
"The results of this study show that lixisenatide once-daily in combination with basal insulin provides a significant reduction in A1C,” said Marc Cluzel, M.D., PhD, Executive Vice President, Research & Development, sanofi-aventis. “Adding lixisenatide, a new GLP-1 with a strong post-prandial glucose effect, to a basal insulin may offer patients a new treatment approach to better control glucose and prevent long-term complications.”
The GETGOAL-L Asia study was a 24-week, double-blind, placebo-controlled, two-arm parallel-group, multicenter trial and it assessed the safety and efficacy of lixisenatide as add-on therapy in a total of 311 Asian patients with type 2 diabetes insufficiently controlled with basal insulin (with or without sulfonylurea). Patients in the study had a baseline A1C levels between 7 and 10%; were 20 years of age or older, and were diagnosed with type 2 diabetes for at least one year before screening visit. They were randomized to add either lixisenatide once-daily, or placebo to their existing treatment regimen. Sixty percent of patients were taking Lantus® (insulin glargine) as their basal insulin.
The study met its primary endpoint, and the addition of lixisenatide once daily to basal insulin significantly reduced A1C levels by 0.88% versus placebo (p<0.0001). The full study findings will be submitted to a medical congress for presentation.
The previously released results of the GETGOAL MONO study, presented earlier this month at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting, also showed that lixisenatide once-daily as monotherapy had a significant effect on postprandial blood glucose control and A1C levels. The results of this second study demonstrate the efficacy of lixisenatide in a different population of type 2 diabetic patients.
Lixisenatide was in-licensed from Zealand Pharma A/S (Copenhagen, Denmark).
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 by sanofi-aventis from Zealand Pharma A/S (Copenhagen, Denmark), www.zealandpharma.com. The efficacy and safety of lixisenatide once-daily is being assessed in the GetGoal Phase III clinical trial program. The GetGoal clinical trial program started in May 2008 and has enrolled more than 4,000 patients. The enrollment of the eight other studies of the GetGoal Phase III program assessing efficacy and safety of lixisenatide in adult patients with type 2 diabetes mellitus treated with various oral antidiabetic agents or insulin was completed at the end of 2009. The next results of the GetGoal Phase III program are expected to be released in Q2 2011.
About GLP-1 Receptor Agonists
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 EASD, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology.
Lantus® is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia and for adult and paediatric patients (6 years and older) with type 1 diabetes mellitus. Lantus® demonstrates a peakless and sustained concentration/time profile over 24h thus reducing the risk of hypoglycemia and allowing a constant and high efficacy over 24h with one single day injection. Lantus® is the number one prescribed insulin worldwide.
About the sanofi-aventis Diabetes Division
Sanofi-aventis strives to be a 360 degree partner delivering innovative and integrated solutions for people living with diabetes. The Company currently has insulin products that are also available as injection pens for people with type 1 or type 2 diabetes. Following the formation of its Diabetes Division, sanofi-aventis has agreements with other companies for the development of blood glucose monitoring solutions and the potential first regenerative treatment for diabetes. Investigational compounds also in the pipeline include the once-daily injectable GLP-1 agonist lixisenatide alone, in combination with basal insulins including Lantus, and in combination with oral antidiabetic agents.
Global Diabetes Division:
Tel: +49 69 305 22283
Corporate Media Relations:
Tel: +33 (0) 1 53 77 45 02
Mobile : +33 (0) 6 08 18 94 78
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). For more information, please visit: www.sanofi-aventis.com.