Sanofi announces new phase 3 results for investigational new insulin U300

EDITION II trial demonstrates similar blood sugar control with fewer night-time low blood sugar events for U300 compared with Lantus®


Sanofi on December 04, 2013, announced the full results from the EDITION II study showing that investigational new insulin U300 demonstrated similar blood sugar control with 23% fewer patients experiencing night-time low blood sugar compared with Lantus® (insulin glargine [rDNA origin] injection). These results were presented today at the International Diabetes Federation 2013 World Diabetes Congress in Melbourne, Australia. The full EDITION II results are consistent with those from EDITION I.1 Both studies were conducted in people with type 2 diabetes already using basal insulin (with mealtime insulin or oral medication).

Sanofi also announced the additional top-line results from the EDITION Phase 3 clinical program. 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.

"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." commented Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi.

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