Screening phase: 2 to 4 weeks
Treatment phase: 24 weeks
At randomization, patients were stratified with respect to their baseline HbA1c level (\<8.5% or ≥8.5%) and hypoglycemic event rate (number of CGMS hypoglycemic excursions \<0.5 or ≥0.5 events per 24 hours). Following randomization, trial basal insulin was initiated and up-titrated within the first 12 weeks to reach a stable dose.
Follow-up phase: 2 weeks
All Phases: 28 to 30 weeks
