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Updated: Jan 6, 2026

Hyperinsulinemic-euglycemic Clamps in Conscious, Unrestrained Mice
Published on: November 16, 2011
Factors Accounting for Pharmacodynamic Variability of Basal Insulin Preparations in Euglycemic Clamp Settings in
Hui Liu1,2, Ting Li3, Hongling Yu1
1Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Guoxue Lane No.37, Wuhou District, Chengdu, Sichuan, China.
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.
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