This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects. Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits. The total trial maximum duration for a subject will be up to 10 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
AUCLispro(0-30min)
Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes
Time frame: Up to 30 minutes
AUCGIR(0-last)
Area under the glucose infusion rate time curve from 0 hours until the end of clamp
Time frame: Up to 8 hours
Adverse Events
Number of adverse events
Time frame: Up to 10 weeks
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Injection of a single dose of Humalog® at the dose of 0.2 U/kg