Outcomes
HYPOGLYCEMIA
The primary efficacy outcome of the extension trial was change from baseline in HbA1c at 24 months. Secondary outcomes were the proportion of participants with HbA1c < 7.0% (53 mmol/mol) or <7.5% (58 mmol/mol), total daily insulin doses, number of daily injections, percentage of participants with hypoglycemia, changes from baseline in body weight and fasting plasma glucose, and the level of satisfaction (DiabetesTreatment Satisfaction Questionnaire—DTSQ) [To limit clinical inertia, in the extension part of the trial clinicians had to improve glycemic control according to a titration algorithm for basal insulin in all three groups and for prandial insulin in the basal-bolus group (Table Titration algorithm for recommended rapid insulin analog dose adjustment in the basal-bolus groupTitration algorithm for recommended basal insulin dose adjustment in the three groups