Patients randomized: Tresiba® (n=228); insulin glargine U-100 (n=229).
Study design: 26-week, randomized, open-label, multicenter trial comparing the efficacy and safety of once-daily Tresiba® U-200 and once-daily insulin glargine U-100, both with metformin with or without a DPP-4 inhibitor. Basal insulin was titrated weekly to an FPG target of 70 to 90 mg/dL according to mean prebreakfast SMBG values (mean of 3 consecutive days).
Primary endpoint: Change in A1C from baseline after 26 weeks of treatment.
Secondary confirmatory endpoints: Number of treatment-emergent confirmed hypoglycemic episodes, change from baseline in FPG, within-subject variability as measured by coefficient of variation, and frequency of participants achieving A1C <7% without confirmed hypoglycemic episodes.
Mean end-of-trial basal insulin doses: Tresiba®, 59 units; insulin glargine U-100, 62 units.