Intensification of Basal Insulin Therapy with Step-Wise Addition of Insulin Aspart Boluses Vs. Basal-Bolus Therapy: the FullSTEP™ Study

This randomized, open-label, parallel-group, multinational 32-week trial compared efficacy and safety of a step-wise vs. basal-bolus insulin regimen in patients with type 2 diabetes inadequately controlled on basal insulin + oral antidiabetic drugs. A total of 590 subjects entered an 8-week run-in period, switching their previous basal insulin to once-daily bedtime insulin detemir. After run-in, subjects with HbA1c 7.0 to 9.0% and fasting plasma glucose (FPG) ≤9.0 mmol/L (n=401; mean age 59.8 years; HbA1c 7.9%; diabetes duration 12.6 years) were randomized 1:1 to step-wise or basal-bolus treatment. The basal-bolus group received insulin aspart 3 times/day for 32 weeks. In the step-wise group, insulin aspart was started before the largest meal. At 11 and 22 weeks, subjects with HbA1c remaining ≥7% were prescribed an additional insulin aspart bolus at the next larger meal. HbA1c change from baseline (last observation carried forward) was −0.98% for step-wise and −1.12% for basal-bolus at 32 weeks; mean treatment difference (MTD) 0.14 [95% CI –0.02;0.30]; NS. FPG was comparable between groups (MTD 0.12 mmol/L; NS). Fewer hypoglycemic episodes were recorded in the step-wise group vs. basal-bolus (rate ratio 0.58 [95%CI 0.45;0.75]; p<0.001). Dropout rate was less for step-wise (14%) than basal-bolus (26%). DiabMedSat patient-reported outcomes indicated better overall satisfaction with the step-wise vs. basal-bolus regimen (p<0.01). At trial end, 44.8% of subjects randomized to step-wise required 1 or 2 injections/day. Step-wise intensification of prandial insulin provides glycemic control comparable to basal-bolus treatment with significantly lower hypoglycemia risk and better patient satisfaction.