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Sanofi Says Late-Stage Trial of Type 2 Drug a Success

French drug maker Sanofi-aventis says that results from a Phase III trial of its experimental type 2 diabetes drug lixisenatide show that the drug successfully lowered patients’ blood glucose levels and body weight, but did not increase the risk of hypoglycemia.

Lixisenatide is a GLP-1 agonist, one of a family of drugs that work by stimulating the release of insulin when blood sugar levels rise too high.

The Phase III study tracked 361 type 2 patients with A1C levels between 7% and 10% who were not receiving any therapy for blood glucose. The patients were divided into three groups, two that took once-daily doses of the drug at different levels of strength, and a third that received a placebo. The test lasted 12 weeks.
 
Sanofi says that the two groups taking the experimental drug experienced “significantly reduced” A1C levels-including levels below 7%-and “significantly improved” fasting plasma glucose and two-hour post-meal glucose.  

If lixisenatide gains FDA approval to go to market, it will join a field of GLP-1 agonists that includes Amylin and Eli Lilly’s Byetta (exenatide) and Novo Nordisk’s Victoza (liraglutide). Financial analysts say the drug could carve out a $500 million niche in the U.S. market.

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