U 300(Sanofi) success in EDITION I and EDITION II trials in Type 2 Diabetes

Sanofi announced that the first phase III study results (EDITION I) for its investigational new insulin U300 (LY 2963016) 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 top line results of a second Phase III 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 III 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.

Topline results of EDITION II are consistent with EDITION I findings. EDITION II demonstrated that investigational new insulin U300 achieved similar blood sugar reduction while fewer patients experienced night-time low blood sugar events compared with Lantus.

New insulin U300 is a new formulation based on the glargine molecule, the biological entity of Lantus. However, new insulin U300 has unique pharmacokinetic and pharmacodynamic profiles with studies demonstrating it has even flatter and more prolonged profiles than Lantus. New insulin U300 also offers the benefit of a smaller volume of subcutaneous injection compared with Lantus.