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. 2024 Jun;26(6):2412-2421. doi: 10.1111/dom.15560. Epub 2024 Apr 1.

Abstract

Aim: To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus.

Methods: This was a phase 3, multicenter, open-label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks. The primary endpoint was the proportion of participants in each treatment arm who manifested treatment-induced anti-insulin antibodies (AIA). Secondary endpoints included efficacy and safety metrics, changes in glycated haemoglobin levels, and a comparative assessment of adverse events. Results were analysed using an equivalence test comparing the limits of the 90% confidence interval (CI) for treatment-induced AIA development to the prespecified margins.

Results: The percentages of participants positive for treatment-induced glycated haemoglobin by week 26 were similar between the GL Glargine (19.2%) and Lantus® (21.3%) treatment groups, with a treatment difference of -2.1 percentage points and a 90% CI (-7.6%, 3.5%) (predefined similarity margins: -10.7%, 10.7%). The difference in glycated haemoglobin was -0.08% (90% CI, -0.23, 0.06). The overall percentage of participants with any treatment-emergent adverse events was similar between the GL Glargine (80.1%) and Lantus® (81.6%) treatment groups.

Conclusions: GL Glargine was similar to Lantus® in terms of immunogenicity, efficacy, and safety, based on the current study.

Keywords: biosimilar; immunogenicity; insulin glargine; type 2 diabetes mellitus.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Biosimilar Pharmaceuticals* / adverse effects
  • Biosimilar Pharmaceuticals* / therapeutic use
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism
  • Diabetes Mellitus, Type 2* / blood
  • Diabetes Mellitus, Type 2* / drug therapy
  • Diabetes Mellitus, Type 2* / immunology
  • Female
  • Glycated Hemoglobin* / analysis
  • Glycated Hemoglobin* / drug effects
  • Glycated Hemoglobin* / metabolism
  • Humans
  • Hypoglycemia / chemically induced
  • Hypoglycemic Agents* / adverse effects
  • Hypoglycemic Agents* / therapeutic use
  • Insulin Antibodies / blood
  • Insulin Glargine* / adverse effects
  • Insulin Glargine* / therapeutic use
  • Male
  • Middle Aged
  • Therapeutic Equivalency
  • Treatment Outcome

Substances

  • Biosimilar Pharmaceuticals
  • Blood Glucose
  • Glycated Hemoglobin
  • hemoglobin A1c protein, human
  • Hypoglycemic Agents
  • Insulin Antibodies
  • Insulin Glargine