Sanofi reports positive phase 3 insulin data
Full results from Sanofi’s phase three clinical trials of its investigational new insulin U300 have been announced. The primary endpoint was met in the 6-month EDITION III, EDITION IV and EDITION JP I studies. Full results will be presented at scientific meetings in 2014.
Sanofi also reported that its trial, EDITION II, showed that U300 demonstrated similar blood sugar control with 23% fewer patients experiencing night-time low blood sugar compared with Lantus. The full EDITION II results are consistent with those from EDITION I. Both studies were conducted in people with type 2 diabetes already using basal insulin (with mealtime insulin or oral medication).
“We are encouraged by these results which suggest that U300 could be a viable treatment option for a wide range of people with type 1 and type 2 diabetes.”
Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi.
Investigational new insulin U300 is a new formulation based on the glargine molecule, the biological entity of Lantus, with its well established efficacy and safety profile. U300 has unique pharmacokinetic and pharmacodynamic profiles with studies demonstrating it has even flatter and more prolonged profiles than Lantus. U300 also offers the benefit of a smaller volume of subcutaneous injection compared with Lantus.
These results were presented at the International Diabetes Federation 2013 World Diabetes Congress in Melbourne, Australia.
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