Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People With Type 1 Diabetes
Authors' conclusion
AT278 U500 offers rapid-acting characteristics in a reduced dose volume, with accelerated absorption and onset of action compared with IAsp U100 in the studied population.
Study context
- Population
- Men with T1D, body weight ≤100 kg and total insulin dose <1.2 units/kg/daycrossover
- Participants
- 38 men
- Comparison
- AT278 U500 vs IAsp U100
- Primary endpoint
- Pharmacokinetics, pharmacodynamics and safety
Methodological detailssingle-center, double-blind, 8-h euglycemic clamp
- Single-center
- Double-blind
- 8-h euglycemic clamp
Primary result
As reported in the abstract
Pharmacokinetics and pharmacodynamics
- AT278 U500
- onset of appearance in serum 6 min earlier; P < 0.0001
- AT278 U500
- time to 50% of maximum concentration 23 min faster; P < 0.0001
- AT278 U500
- insulin exposure, first 30 min 4.0-fold higher (95% CI 3.29–4.90)
- AT278 U500
- insulin exposure, first 60 min 1.5-fold higher (95% CI 1.35–1.76)
- AT278 U500
- onset of action 10 min earlier; P < 0.0001
- AT278 U500
- time to 50% of maximum glucose infusion rate 20 min faster; P < 0.0001
- AT278 U500
- glucose-lowering effect, first 30 min 8.9-fold higher (95% CI 5.96–17.46)
- AT278 U500
- glucose-lowering effect, first 60 min 2.4-fold higher (95% CI 1.92–3.22)
Safety
- No significant safety findings
Original publication
Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People With Type 1 Diabetes. Diabetes Care. Published 30 January 2023. doi:10.
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