Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Glargine (Gan & Lee Glargine) Compared With Originator Insulin Glargine (Lantus) in Patients With Type 1 Diabetes After 26 Weeks Treatment
Authors' conclusion
GL Glargine demonstrated similar immunogenicity, efficacy, and safety compared to Lantus over 26 weeks in patients with T1DM.
Study context
- Population
- Patients with T1Drandomized 1:1
- Participants
- 576 patients
- Comparison
- Biosimilar insulin glargine vs originator insulin glargine
- Primary endpoint
- Percentage of subjects developing treatment-induced anti-insulin antibody after baseline, evaluated by a country-adjusted logistic regression model
- Follow-up
- Up to week 26
Methodological detailsphase 3, multicenter, open-label, equivalence
- Phase 3
- Multicenter
- Open-label
- Equivalence
Primary result
As reported in the abstract
Treatment-induced anti-insulin antibody positive · Week 26
90% CI −5.4 to 6.5
Further findings
| Outcome | Least squares mean difference (90% CI) | |
|---|---|---|
| Change in HbA1c · 26 weeks | −0.08 (−0.23 to 0.06) | |
| −0.3−0.2−0.100.1Difference (linear scale) |
Other immunogenicity
- Other immunogenicity profiles comparable
Safety
Safety, including AEs and hypoglycemia
- Safety profiles comparable
Original publication
Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Glargine (Gan & Lee Glargine) Compared With Originator Insulin Glargine (Lantus) in Patients With Type 1 Diabetes After 26 Weeks Treatment. Endocr Pract. Published 12 June 2024. doi:10.
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