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.
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.Click Here To View Or Post Comments