Phase 3 efficacy and safety trial of proposed liraglutide biosimilar for reduction of glycosylated hemoglobin (HbA1c) in patients with Type 2 diabetes mellitus
Authors' conclusion
Levim liraglutide demonstrated non-inferior efficacy and similar safety to reference liraglutide
Study context
- Population
- Patients aged 18–65 years with T2DM and HbA1c between 7 and 10 %randomized 1:1
- Comparison
- Levim liraglutide vs reference liraglutide
- Primary endpoint
- Reduction in HbA1c%
- Follow-up
- Week 24
Methodological detailsphase 3, non-inferiority, biosimilar
- Phase 3
- Non-inferiority
- Biosimilar
Primary result
As reported in the abstract
Levim liraglutide
−1.09
least square mean · SE 0.15 · %
Reference liraglutide
−1.04
least square mean · SE 0.14 · %
P = 0.0003
Secondary outcomes
Proportion achieving HbA1c reduction, glycaemic level, weight, cardiovascular parameters
- Comparable between groups
Safety
- Overall safety profiles of the study drugs were comparable
Original publication
Phase 3 efficacy and safety trial of proposed liraglutide biosimilar for reduction of glycosylated hemoglobin (HbA1c) in patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract. Published 5 December 2023. doi:10.
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