Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar insulin N with US ‐licensed Humulin® N formulation in healthy subjects: Results from the RHINE ‐2 (Recombinant Human INsulin Equivalence‐2) study
Authors' conclusion
PK and PD equivalence was shown between Biocon's Insulin-N and Humulin-N in healthy subjects, and both treatments were well tolerated and considered safe.
Study context
- Population
- Healthy subjects85 completed
- Participants
- 90 subjects
- Comparison
- Biocon's Insulin-N vs Humulin® N (Humulin-N)
- Primary endpoint
- Pharmacokinetic (PK): AUCins.0-24h and Cins.max; PD: AUCGIR.0-24h and GIRmax
- Follow-up
- 0 to 24 h
Methodological detailsphase 1, single-centre, double-blind, three-period, six-sequence, partially replicated crossover, 24-h euglycaemic clamp
- Phase 1
- Single-centre
- Double-blind
- Three-period, six-sequence, partially replicated crossover
- 24-h euglycaemic clamp
Primary result
As reported in the abstract
Geometric least squares mean ratio, AUCGIR.0-24h
104.61%
Biocon's Insulin-N
Geometric least squares mean ratio, GIRmax
100.81%
Biocon's Insulin-N
- Intra-subject variability (pharmacodynamic (PD))
- ≥0.294
Safety
- Serious adverse events
- 0
- Safety profile of Biocon's Insulin-N similar to Humulin-N
Original publication
Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar insulin N with US ‐licensed Humulin® N formulation in healthy subjects: Results from the RHINE ‐2 (Recombinant Human INsulin Equivalence‐2) study. Diabetes Obes Metab. Published 14 February 2023. doi:10.
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