Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial
Authors' conclusion
PK exposure of SAR-Asp (switching group) and reference NN-Asp (non-switching group) were similar, supporting interchangeability between these two insulin aspart products.
Study context
- Population
- Adults with T1D treated with once-daily insulin glargine U100 as basal insulinrandomized 1:1
- Participants
- 210 adults
- Comparison
- Multiple switches between SAR-Asp and NN-Asp vs continuous NN-Asp
- Switchingn = 95
- Non-switchingn = 105reference
- Primary endpoint
- AUC and Cmax of SAR-Asp vs NN-Asp after a single dose (0.15 U/kg)
- Follow-up
- Week 16
Methodological detailsmulticentre, open-label, phase 3
- Multicentre
- Open-label
- Phase 3
Primary result
As reported in the abstract
PK exposure (AUC, Cmax)
Cmax upper confidence limit, primary analysis set (due to 3 participants with implausible high values)
1.32
Original publication
Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial. Diabetes Obes Metab. Published 25 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →