Sanofi announced the full results from the EDITION II study showing that investigational new U300 insulin demonstrated similar blood sugar control as Lantus insulin while 23% fewer patients experienced night-time low blood sugar (nocturnal hypoglycemia). These results were presented at the International Diabetes Federation 2013 World Diabetes Congress in Melbourne, Australia.
Investigational new U300 insulin 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 insulin also offers the benefit of a smaller volume of subcutaneous injection compared with Lantus.
The full EDITION II study results are consistent with those from the EDITION I study. Sanofi has also announced 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.
Both the the EDITION I and the EDITION II studies were conducted in people with type 2 diabetes already using basal insulin (with mealtime insulin or oral medication). The EDITION III is being conducted on insulin-naïve people with type 2 diabetes while EDITION IV and EDITION JP I (Japan) are being conducted on people with type 1 diabetes.