This randomized, double-blind, cross-over study compared PK/PD-properties of Humalog and GN1101DP, a proposed insulin lispro (INS) biosimilar with an identical primary structure and high physicochemical and bio-functional similarity to Humalog. Thirty-five Caucasian and 13 Chinese healthy subjects completed the study and received a single dose of 0.3 U/kg of GN1101DP and Humalog under euglycemic automated glucose clamp conditions (ClampArt®, plasma glucose (PG) target 81 mg/dL, clamp duration 12 hours post-dose, wash-out period 2-14 days between the two dosings). Plasma INS concentrations were determined by tandem ultra performance liquid chromatography-mass spectrometry. GN1101DP demonstrated both PK- and PD-bioequivalence to Humalog with superimposable INS concentration and glucose infusion rate (GIR) profiles, point estimates close to 100%, and 90% confidence intervals were within the pre-defined similarity range of 80-125%. Bioequivalence was observed in all and also separately in Caucasian and Chinese subjects (Figure). Clamp quality was high (mean PG-variations of ~5% and deviations from target <0.6 mg/dL). Both lispro formulations were well tolerated. No injection site reactions occurred. In conclusion, GN1101DP demonstrated PK- and PD-bioequivalence to Humalog in Caucasian and Chinese subjects.
T.Heise: Advisory Panel; Novo Nordisk, Consultant; Gan & Lee Pharmaceuticals, Research Support; Adocia, AstraZeneca, Biocon, Crinetics Pharmaceuticals, Inc., Eli Lilly and Company, Genova, Novo Nordisk, Sanofi, Zealand Pharma A/S, Speaker's Bureau; Eli Lilly and Company, Novo Nordisk. E.Zijlstra: Other Relationship; Eli Lilly and Company, Speaker's Bureau; Gan & Lee Pharmaceuticals, Novo Nordisk A/S. G.Andersen: None. S.B.Selker: None. C.Shen: None. Y.Wang: None.
Genova Biotech Pvt. Ltd.
