Tresiba insulin degludec: Phase III data

The open-label, international Phase III BEGIN YOUNG 1 trial in about 350 Type I diabetics ages 1-17 showed that once-daily subcutaneous Tresiba plus a bolus of insulin aspart met the primary endpoint of non-inferiority to once- or twice-daily insulin detemir plus a bolus of insulin aspart in reducing mean HbA1c from baseline to week 26 (p<0.05 for non-inferiority). Additionally, Tresiba plus a bolus of insulin aspart significantly reduced FPG from baseline to week 52 vs. insulin detemir plus a bolus of insulin aspart (p<0.05). Both treatment arms had similar rates of overall and nocturnal hypoglycemia, but the rate of severe hypoglycemia was numerically higher in the Tresiba arm compared to the insulin detemir arm. Data were presented at the European Association for the Study of Diabetes meeting in Vienna. ...