Sanofi announced today that the first Phase 3 study results (EDITION I) for its investigational new insulin U300 showed equivalent blood sugar control with fewer night-time low blood sugar events compared to Lantus® (insulin glargine [rDNA origin] injection). The company also announced topline results of a second Phase 3 study (EDITION II) for new insulin U300 that also demonstrated similar blood sugar reduction while fewer patients experienced night-time low blood sugar events compared with Lantus®.
These results are from EDITION I and EDITION II respectively and are part of the EDITION Phase 3 clinical program evaluating the efficacy and safety of the investigational new insulin U300 in people with diabetes. The EDITION I data was presented at the 73rd Scientific Sessions of the American Diabetes Association.
"To properly manage diabetes, it is critical to control blood sugar and to reduce the risk of low blood sugar events, especially at night," said Matthew Riddle, Professor of Medicine, Division of Endocrinology/Diabetes/Clinical Nutrition, Oregon Health and Science University, U.S., and Principal Investigator for the EDITION I study. "I am encouraged by these findings, and look forward to the results of the full Phase 3 EDITION program, which will further reveal how this investigational basal insulin may help people living with diabetes."