Immunogenicity, efficacy and safety of a biosimilar insulin glulisine compared with originator in adults with type 1 diabetes mellitus: A phase III randomised clinical trial
Authors' conclusion
T-Glu demonstrated similar immunogenicity, efficacy, and safety to R-Glu in adults with T1DM, supporting its use as a biosimilar insulin glulisine.
Study context
- Population
- Adults with T1D
- Comparison
- Biosimilar insulin glulisine vs reference product
- Primary endpoint
- Proportion of patients with an immune response
- Follow-up
- Week 26
Methodological detailsphase III, open-label
- Phase III
- Open-label
Primary result
As reported in the abstract
Persistent immune response
P > 0.05
Secondary outcomes
| Outcome | T-Glu | R-Glu | Mean difference (%) (95% CI) | |
|---|---|---|---|---|
| HbA1c change from baseline · Week 26Non-inferiority demonstrated (predefined margin 0.4%) | mean 0.53 ± 1.19% % | mean 0.38 ± 1.46% % | −0.15 (−0.50 to 0.20) | |
| −0.6−0.4−0.200.20.4Difference, % (linear scale) |
- FPG and seven-point glucose profile · no significant differences
- P > 0.05
- Insulin dose and treatment satisfaction · satisfaction improved comparably
- P > 0.05
- HbA1c change from baseline: non-inferiority margin of 0.4%
Insulin dose and treatment satisfaction
- Insulin dose remained stable throughout the study
Safety
| Outcome | P value |
|---|---|
| AEs and hypoglycaemiaHypoglycaemia more frequent with R-Glu | P < 0.001 |
AEs and hypoglycaemia
- Total number of AEs similar; no new safety concerns
Original publication
Immunogenicity, efficacy and safety of a biosimilar insulin glulisine compared with originator in adults with type 1 diabetes mellitus: A phase III randomised clinical trial. Diabetes Obes Metab. Published 9 December 2025. doi:10.
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