Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU ‐ und US‐sourced reference insulins
Authors' conclusion
GL-Asp, GL-Lis and GL-Gla are bioequivalent to their EU- and US-reference products.
Study context
- Population
- Healthy male participants (GL-Asp and GL-Lis) or people with T1D (GL-Gla)3 crossover trials
- Comparison
- Gan & Lee biosimilar insulins aspart, lispro and glargine vs EU- and US-sourced reference products
- GL-Aspn = 36
- GL-Lisn = 38
- GL-Glan = 113
- Primary endpoint
- PK: AUCins.total and Cins.max; PD: AUCGIR.total and GIRmax
- Follow-up
- Clamp duration 12 h (aspart, lispro) or 30 h (glargine)
Methodological detailsthree phase 1 crossover bioequivalence trials, randomized, double-blind, three-period crossover, automated euglycaemic clamp
- Three phase 1 crossover bioequivalence trials
- Randomized
- Double-blind
- Three-period crossover
- Automated euglycaemic clamp
Primary result
As reported in the abstract
Bioequivalence of primary PK/PD endpoints vs EU- and US-reference
- Bioequivalence to both EU- and US-reference products shown for all three GL insulins
- Least squares mean ratios for primary pharmacokinetic (PK)/pharmacodynamic (PD) endpoints close to 100%
- Both 90% and 95% CIs within 80%-125% in all three studies
Safety
- Serious adverse events with GL insulins
- 0
- No noticeable differences in safety profiles between test and reference insulins
Original publication
Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU ‐ und US‐sourced reference insulins. Diabetes Obes Metab. Published 21 September 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →