Objective: To evaluate efficacy and safety of faster-acting insulin aspart (Fiasp) compared to insulin aspart (Iasp) in adults with type 1 diabetes using non-automated insulin pump and continuous glucose monitoring (CGM).
Methods: In this double-blinded crossover trial participants were randomly assigned to start with Fiasp or Iasp for 16 weeks and then switch to the alternate therapy for another 16 weeks following a 3-week washout period. Insulin pump settings were adjusted every 3 weeks based on CGM and insulin pump data. Primary outcome was the between-treatment difference in time in range (TIR: 3.9-10.0 mmol/L) from week 14 to 16. Secondary outcomes included other CGM metrics and HbA1c. Safety outcomes included injection site reactions.
Results: Forty adults (20 males) with a median (IQR) age of 54 (44-61) years, type 1 diabetes duration of 27 (20-34) years, HbA1c 59 (55-65) mmol/mol or 7.5 (7.2-8.1) %, BMI 25.7 (24.5-30.3) kg/m2 and total daily insulin dose 37 (29-52) IE completed both study arms. At 16 weeks, TIR was (mean ± SD) 60.6 ± 12.1% for Iasp and 62.5 ± 12.3% for Fiasp, p = 0.24; time above range (>10.0 mmol/L) was 31.5 ± 12.6% for Iasp and 30.1 ± 11.3% for Fiasp, p=0.30; and time below range (<3.9 mmol/L) was 7.8 ± 5.5% for Iasp and 7.5 ± 6.1% for Fiasp, p=0.89. The coefficient of variation was significantly higher with Iasp compared to Fiasp (35.9 ± 4.9% vs 34.0 ± 3.7%, p=0.03). At week 16, HbA1c was 58.0 ± 6.6 mmol/mol with Iasp and 57.5 ± 6.9 mmol/mol with Fiasp (p= 0.43). No differences were observed in SAE including severe hypoglycemia and diabetes ketoacidosis. Fiasp had numerically more events of burning sensation at injection site than Iasp.
Conclusion: At 16 weeks, after frequent adjustments of insulin pump settings, no differences between Fiasp and Iasp treatment were observed in TIR, TAR, TBR and HbA1c in adults with type 1 diabetes using insulin pump and CGM. However, Fiasp significantly reduced glycemic variability compared to Iasp.
A.G. Ranjan: None. S. Schmidt: Employee; Novo Nordisk A/S. Speaker's Bureau; Novo Nordisk A/S. H. Andersen: None. K. Nørgaard: Research Support; Dexcom, Inc., Medtronic. Advisory Panel; Medtronic, Novo Nordisk A/S. Stock/Shareholder; Novo Nordisk A/S. Research Support; Novo Nordisk A/S. Advisory Panel; Convatec. Research Support; Zealand Pharma A/S.
Steno Diabetes Center Copenhagen is the sponsor of this investigator-initiated trial. Novo Nordisk provided financial support to the conduct of the study and supplied the study medication.
