BioCentury
ARTICLE | Clinical News

U300: Phase III data

July 1, 2013 7:00 AM UTC

Top-line data from the open-label, international Phase III EDITION II trial in 811 Type II diabetics showed that once-daily subcutaneous U300 as an add-on to oral antidiabetic drugs met the primary endpoint of non-inferiority to once-daily Lantus insulin glargine as an add-on to oral antidiabetic drugs in reducing HbA1c from baseline to 6 months. U300 also met the secondary endpoint of a smaller proportion of patients with >=1 severe or confirmed nocturnal hypoglycemic event from month 3 to 6 vs. Lantus. ...