Duration of action of two insulin glargine products, LY2963016 insulin glargine and Lantus insulin glargine, in subjects with type 1 diabetes mellitus

• Published in: Diabetes, obesity & metabolism Vol. 19; no. 1; pp. 33 - 39
• Main Authors: Linnebjerg, Helle, Lam, Eric Chen Quin, Zhang, Xin, Seger, Mary E., Coutant, David, Chua, Laiyi, Kapitza, Christoph, Heise, Tim
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.01.2017; Wiley Subscription Services, Inc
• Subjects: Adult; basal insulin; biosimilar insulin; Blood glucose; Blood Glucose - drug effects; Blood Glucose - metabolism; clinical trial; Cross-Over Studies; Diabetes; Diabetes Mellitus, Type 1 - drug therapy; Diabetes Mellitus, Type 1 - metabolism; Double-Blind Method; Female; Glucose; Glucose Clamp Technique; Humans; Hypoglycemic Agents - pharmacology; Insulin; Insulin Glargine - analogs & derivatives; Insulin Glargine - pharmacology; Male; Middle Aged; Original; Pharmacodynamics; phase I–II study; Time Factors; type 1 diabetes; clinical trial; basal insulin; biosimilar insulin; type 1 diabetes; phase I-II study; pharmacodynamics
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.12759

Aims LY2963016 (LY IGlar) and Lantus (IGlar) are insulin glargine products manufactured by distinct processes, but with identical amino acid sequences. This study compared the duration of action of LY IGlar and IGlar in subjects with type 1 diabetes mellitus (T1DM). Materials and methods This was a randomized, double‐blind, single‐dose, two‐period, crossover study. Twenty subjects underwent 42‐hour euglycaemic clamps after a single subcutaneous 0.3‐U/kg dose of LY IGlar or IGlar. In this study, the duration of action was defined as the time required for blood glucose levels to rise consistently above a predefined cut‐off of 8.3 mmol/L (150 mg/dL) from a state of euglycaemia. Blood samples were collected to measure blood glucose for pharmacodynamic (PD) evaluations. Results End of action was reached within 42 hours in 26 of 40 clamps (13 LY IGlar and 13 IGlar). The median duration of action for all subjects was 37.1 and 40.0 hours, and the mean duration of action (calculated using only patients who reached end of action) was 23.8 and 25.5 hours for LY IGlar and IGlar, respectively. The duration of action was demonstrated to be similar between the treatments using time‐to‐event analysis (log‐rank test of equality p = .859). Following administration of LY IGlar and IGlar, the PD parameters of maximum glucose infusion rate (R max) and total glucose infusion during the clamp (G tot) were comparable. Conclusion LY IGlar and IGlar had similar duration of action and comparable PD parameters in subjects with T1DM.