Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study
Primary result · Participants positive for treatment-induced AIA (results sentence prints 'treatment-induced glycated haemoglobin')Result — go to the resultTreatment difference −2.1 percentage points 90% CI −7.6% to 3.5%Authors' conclusion
GL Glargine was similar to Lantus® in terms of immunogenicity, efficacy, and safety, based on the current study.
Study context
- Population
- Adults with T2Drandomized 1:1
- Participants
- 567 adults
- Comparison
- Gan & Lee (GL) Glargine vs Lantus®
- Primary endpoint
- Proportion of participants with treatment-induced anti-insulin antibodies (AIA)
- Follow-up
- 26 weeks
Methodological detailsphase 3, multicentre, open-label, equivalence, 57 sites
- Phase 3
- Multicentre
- Open-label
- Equivalence
- 57 sites
Primary result
As reported in the abstract
Participants positive for treatment-induced AIA (results sentence prints 'treatment-induced glycated haemoglobin') · week 26
Treatment difference
−2.1 percentage points
90% CI −7.6% to 3.5%
By group
GL Glarginevs Lantus®
treatment difference −2.1 percentage points (90% CI −7.6% to 3.5%)
Secondary outcomes
| Outcome | Difference (%) (90% CI) | |
|---|---|---|
| HbA1c | −0.08 (−0.23 to 0.06) | |
| −0.3−0.2−0.100.1Difference, % (linear scale) |
Safety
Any treatment-emergent adverse events
Any treatment-emergent adverse events
- Similar between groups
Original publication
Immunogenicity, efficacy, and safety of biosimilar insulin glargine (Gan & Lee glargine) compared with originator insulin glargine (Lantus®) in patients with type 2 diabetes after 26 weeks' treatment: A randomized open label study. Diabetes Obes Metab. Published 1 April 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →