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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 .

diabetes, obesity and metabolism

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