–0.15% [95% CI, –0.23, –0.07] estimated treatment difference between mealtime Fiasp® vs NovoLog®
Fiasp® was effective in lowering A1C1

Demonstrated A1C reductions when dosed at mealtime or postmeal1
onset 1 • 26 weeks, adults with type 1 diabetes
A1C reductions vs NovoLog® (insulin aspart injection) 100 U/mL (adjusted change from baseline)1,2,a

Greater decrease than NovoLog®

Noninferior to NovoLog®
0.04% [95% CI,
–0.04, 0.12] estimated treatment difference between postmeal Fiasp® vs NovoLog®
Baseline A1C for both Fiasp® arms was 7.6% with an end-of-trial A1C of 7.3% for mealtime Fiasp® + insulin detemir and 7.5% for postmeal Fiasp® + insulin detemir. The baseline A1C for NovoLog® + insulin detemir was 7.6% with an end-of-trial A1C of 7.4%.2
aPrimary outcome was tested for noninferiority. Superiority could not be confirmed, as this was not part of the hierarchical testing procedure.

Results are from a 26-week randomized, active-controlled, treat-to-target, multicenter trial in 1143 adult patients with type 1 diabetes comparing Fiasp® (mealtime and postmeal dosing) to mealtime NovoLog®.

In adults with T1D
Proven A1C reductions when added to insulin degludec3
onset 8 • 26 weeks, adults with type 1 diabetes
A1C reductions when added to insulin degludec vs NovoLog® (insulin aspart injection) 100 U/mL (adjusted change from baseline)3

Noninferior to NovoLog® for both mealtime and postmeal dosing
Estimated treatment differences: −0.02% [95% CI,−0.11, 0.07], mealtime Fiasp® vs NovoLog®; 0.10% [95% CI, 0.004, 0.19], postmeal Fiasp® vs NovoLog®
Fiasp® + insulin degludec U-100 (mealtime) (0.2 U/kg dose)

Fiasp® + insulin degludec U-100 (postmeal) (0.2 U/kg dose)

NovoLog® + insulin degludec U-100 (insulin aspart injection) 100 U/mL (mealtime) (0.2 U/kg dose)

Baseline A1C for mealtime Fiasp® + insulin degludec was 7.5%, with an end-of-trial A1C of 7.3%. Baseline A1C for postmeal Fiasp® + insulin degludec was 7.4%, with an end-of-trial A1C of 7.4%. The baseline A1C for NovoLog® + insulin degludec was 7.4%, with an end-of-trial A1C of 7.3%.3
Mealtime is defined as injection 0-2 minutes before the start of a meal.
Postmeal dosing was defined as injection at the end of the meal, no later than 20 minutes after the start of the meal.
T1D=type 1 diabetes; CI=confidence interval.

Results are from a 26-week randomized, active-controlled, treat-to-target, multicenter trial in 1025 adult patients with type 1 diabetes comparing Fiasp® (mealtime and postmeal dosing) to mealtime NovoLog®.

Demonstrated superior A1C reductions vs basal insulin alone1,4
onset 3 • 18 weeks, adults with type 2 diabetes
A1C reductions when used in a basal/bolus regimen vs basal insulin (adjusted change from baseline)1,4

Greater decrease than basal insulin alone
–0.94% [95% CI, –1.17, –0.72] estimated treatment difference between Fiasp® + basal insulin vs basal insulin
Baseline A1C for Fiasp® + basal insulin + MET was 7.9% with an end-of-trial A1C of 6.8%. The baseline A1C for basal insulin + MET was 7.9% with an end-of-trial A1C of 7.7%.4

Results are from an 18-week randomized, open-label, parallel group trial in 236 adult patients with type 2 diabetes comparing mealtime Fiasp® plus basal insulin vs basal insulin alone.

Safety results1
onset 1 • 26 weeks, adults with type 1 diabetes
- Proportion (%) of patients experiencing at least 1 episode of severe hypoglycemia2,b:
Mealtime Fiasp® + insulin detemir: 6.7%; postmeal Fiasp® + insulin detemir: 8.0%
onset 8 • 26 weeks, adults with type 1 diabetes
- Proportion (%) of patients experiencing at least 1 episode of severe hypoglycemia3,b:
mealtime Fiasp® + insulin degludec, 9.4%;postmeal Fiasp® + insulin degludec, 5.6%
onset 3 • 18 weeks, adults with type 2 diabetes
- Proportion (%) of patients experiencing at least 1 episode of severe hypoglycemia4,b: 2.6%
Adverse events occurring in ≥5% of adult patients1,c (mealtime; postmeal included):
- Type 1 diabetes (mealtime; postmeal): nasopharyngitis (20.2%; 23.9%), upper respiratory tract infection (9.1%; 7.4%), nausea (4.9%; 5.0%), diarrhea (5.4%; 3.2%), and back pain (5.2%; 4.0%)
- Type 2 diabetes: urinary tract infection (5.9%)
bSevere hypoglycemia (ADA classification): an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
cIncidence ≥5% and occurring at the same rate or greater with Fiasp® than comparator.

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 Design1,3:
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® 100 U/mL (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.
onset 3 (Study C) Study Design1,4:
Population: Adults with type 2 diabetes.
Study Design: 18-week randomized, open-label, parallel group trial in 236 adult patients with type 2 diabetes who were inadequately controlled at baseline who were on basal insulin and metformin therapy, either with (A1C 7.5%-9.0%) or without (A1C 7.5%-9.5%) other oral antidiabetic therapy, for at least 3 months. Patients were randomized to either mealtime Fiasp® in addition to basal insulin (n=116) or to continuing basal insulin and metformin therapy without Fiasp® (n=120). The basal insulins used in both treatment arms were insulin glargine U-100, insulin detemir, or NPH. All patients were also required to be on ≥1000 mg metformin treatment at baseline. Mealtime Fiasp® was injected 0-2 minutes before the meal.
Primary endpoint: Change in A1C from baseline after 18 weeks of treatment. Superiority of Fiasp® when used in a basal/bolus regimen vs basal insulin was confirmed.