More Phase III data for Sanofi's new insulin glargine formulation

Sanofi (Euronext:SAN; NYSE:SNY) reported data on Tuesday from three Phase III trials evaluating once-daily subcutaneous U300 to treat Type I and Type II diabetes. U300 is a new insulin glargine formulation (300 units/mL) that provides a prolonged duration of action compared to the pharma's Lantus insulin glargine (100 units/mL) at single subcutaneous doses. Next half, Sanofi plans to submit regulatory applications to FDA and EMA for the product to treat both Type I and II diabetes.

In 243 Type I diabetics in the Phase III EDITION JP I trial, U300 met the primary endpoint of non-inferiority to once-daily Lantus in reducing HbA1c from baseline to six months (0.3% vs. 0.43%). In 549 Type I diabetics in the Phase III EDITION IV trial, U300 also met the primary endpoint of non-inferiority to once-daily Lantus in reducing HbA1c from baseline to six months (0.4% vs. 0.44%). Patients in both trials were treated with basal and mealtime insulin. Additionally, in the Phase III EDITION III trial in 878 Type II diabetics not previously treated with insulin and uncontrolled on oral antidiabetic drugs, add-on therapy with U300 met the primary endpoint of non-inferiority to add-on therapy with once-daily Lantus in reducing HbA1c from baseline to six months (1.42% vs. 1.46%). ...