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Background <p>The euglycemic clamp technique is a standard method for assessing the pharmacokinetics (PK) and pharmacodynamics (PD) of insulin biosimilars compared to their reference products. Despite similar pharmacokinetic profiles, differences in the pharmacodynamic profiles between a basal insulin biosimilar and its reference product are not uncommon. This study aimed to identify potential factors contributing to this phenomenon.</p> Methods <p>Data were collected from euglycemic clamp studies comparing the PK/PD profiles of an insulin degludec biosimilar (BioIDeg) and the reference product, Tresiba. The ratio of the area under the curve of IDeg from 0 to 24 h (AUC<sub>IDeg,0-24h</sub>) for BioIDeg to Tresiba was calculated. Subjects with an AUC<sub>IDeg,0-24h</sub> ratio of 0.9 to 1.1 were enrolled and categorized based on the AUC<sub>GIR,0-24h</sub> ratio (Group A: AUC<sub>GIR,0-24h</sub> ratio &lt; 0.80 or &gt; 1.25; Group B: 0.80 ≤ AUC<sub>GIR,0-24h</sub> ratio ≤ 1.25). Differences between groups and treatments were analyzed.</p> Results <p>Fifty-eight healthy subjects were included, with 20 in group A and 38 in group B. Significant differences were found in target blood glucose (BG), basal C-peptide, AUC<sub>IDeg,0-12h</sub>, AUC<sub>IDeg,0-24h</sub>, and target BG variations. Logistic regression analysis identified variations in target BG (standardized odds ratio 1.384, <i>P</i>=0.038) as an independent factor.</p> Conclusion <p>Variations in target BG might contribute to PD variability of long-acting insulin preparations in euglycemic clamp settings in healthy individuals.</p>

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Factors Accounting for Pharmacodynamic Variability of Basal Insulin Preparations in Euglycemic Clamp Settings in Healthy Individuals

  • 期刊论文

  • 发表日期：

    2025年12月1日

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  • Hui Liu,
  • Ting Li,
  • Hongling Yu,
  • Xinlei Chen,
  • Jiaqi Li,
  • Huiwen Tan,
  • Yerong Yu

摘要

Background

The euglycemic clamp technique is a standard method for assessing the pharmacokinetics (PK) and pharmacodynamics (PD) of insulin biosimilars compared to their reference products. Despite similar pharmacokinetic profiles, differences in the pharmacodynamic profiles between a basal insulin biosimilar and its reference product are not uncommon. This study aimed to identify potential factors contributing to this phenomenon.

Methods

Data were collected from euglycemic clamp studies comparing the PK/PD profiles of an insulin degludec biosimilar (BioIDeg) and the reference product, Tresiba. The ratio of the area under the curve of IDeg from 0 to 24 h (AUCIDeg,0-24h) for BioIDeg to Tresiba was calculated. Subjects with an AUCIDeg,0-24h ratio of 0.9 to 1.1 were enrolled and categorized based on the AUCGIR,0-24h ratio (Group A: AUCGIR,0-24h ratio < 0.80 or > 1.25; Group B: 0.80 ≤ AUCGIR,0-24h ratio ≤ 1.25). Differences between groups and treatments were analyzed.

Results

Fifty-eight healthy subjects were included, with 20 in group A and 38 in group B. Significant differences were found in target blood glucose (BG), basal C-peptide, AUCIDeg,0-12h, AUCIDeg,0-24h, and target BG variations. Logistic regression analysis identified variations in target BG (standardized odds ratio 1.384, P=0.038) as an independent factor.

Conclusion

Variations in target BG might contribute to PD variability of long-acting insulin preparations in euglycemic clamp settings in healthy individuals.