onset® 1 (Study A) Study Design1,2:

Population: Adults with type 1 diabetes.

Study design: 26-week, randomized, active-controlled, treat-to-target, multicenter trial in 1143 adult patients with type 1 diabetes inadequately controlled at baseline (A1C of 7.0%-9.5%) who were on basal/bolus insulin therapy for at least 12 months. Patients were randomized to either blinded mealtime Fiasp® (n=381), blinded mealtime NovoLog® (n=380), or open-label postmeal Fiasp® (n=382), all in combination with once- or twice-daily insulin detemir. At randomization, patients in Fiasp® arms were switched to Fiasp® on a unit-to-unit basis from their pretrial bolus insulin. Mealtime Fiasp® or NovoLog® was injected 0-2 minutes before the meal, and postmeal Fiasp® was injected 20 minutes after the start of the meal.

Primary endpoint: Change in A1C from baseline after 26 weeks of treatment. Noninferiority of Fiasp® (mealtime and postmeal dosing) to mealtime NovoLog® was confirmed.

onset® 8 Study Design3:

Population: Adults with type 1 diabetes.

Study design: 26-week, randomized, active-controlled, treat-to-target, multicenter trial in 1025 adult patients with type 1 diabetes inadequately controlled at baseline (A1C of 7.0%-9.5%) who were on basal-bolus insulin therapy for at least 12 months. Patients were randomized to either blinded mealtime Fiasp® (n=342), blinded mealtime NovoLog® (n=342), or open-label postmeal Fiasp® (n=341), all in combination with once-daily insulin degludec. At randomization, patients in Fiasp® arms were switched to Fiasp® on a unit-to-unit basis from their pretrial bolus insulin. Mealtime Fiasp® or NovoLog® was injected 0-2 minutes before the meal, and postmeal Fiasp® was injected at the end of the meal, no later than 20 minutes after the start of the meal.

Primary endpoint: Change in A1C from baseline after 26 weeks of treatment. Noninferiority of Fiasp® (mealtime and postmeal dosing) to mealtime NovoLog® was confirmed.