U300: Phase III data

The open-label, international Phase III EDITION I trial in 807 Type II diabetics showed that once-daily subcutaneous U300 as an add-on to mealtime insulin met the primary endpoint of non-inferiority to once-daily Lantus glargine as an add-on to mealtime insulin in reducing mean HbA1c from baseline to 6 months (0.83% for both). U300 also met the secondary endpoint of a lower proportion of patients with >=1 severe or confirmed nocturnal hypoglycemic event from month 3 to 6 vs. Lantus (36.1% vs. 46%, p=0.0045). Additionally, a smaller proportion of patients receiving U300 experienced any nocturnal hypoglycemic event through 6 months vs. Lantus (45.3% vs. 59.7%). U300 was well tolerated. Data were presented at the American Diabetes Association meeting in Chicago. ...