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Investigational Compound Once-Daily Lixisenatide Demonstrated Significant Improvement in Glucose Control in Patients with Type 2 Diabetes
Date:9/20/2010

PARIS, Sept. 20 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the first Phase III results of the GetGoal clinical trial program assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, as monotherapy in patients with type 2 diabetes. These results were presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

"These results demonstrated lixisenatide as a once daily GLP-1 agent with substantial A1C reduction and a pronounced effect on post-meal glucose control," said Dr. John E. Gerich of the University of Rochester School of Medicine and an investigator of the presented study. "The pronounced effect on postprandial glucose control provides a rationale to investigate the combined effect of lixisenatide and long-acting insulins in patients with type 2 diabetes."

The safety and efficacy of lixisenatide as monotherapy in patients with type 2 diabetes was assessed in a 12-week, randomized, double-blind, multicenter Phase III study. The study found that lixisenatide monotherapy administered once daily significantly improved glycemic control with a pronounced postprandial effect. The study also demonstrated that the therapy had an acceptable safety profile in patients with type 2 diabetes.

A total of 361 patients with type 2 diabetes (baseline A1C levels: 7 to 10 percent, mean age 53.7 years, mean diabetes duration 2.5 years) not currently receiving glucose-lowering therapy were randomized to: lixisenatide two-step titration (10 microgram for 1 week, 15 microgram for 1 week then 20 microgram; n=120); lixisenatide one-step titration (10 microgram for 2 weeks then 20 microgram; n=119) or placebo (n=122).

Lixisenatide significantly reduced A1C levels in both titration groups versus placebo (p<0.0001). There was a significa
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