This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects. Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
Injection of BioChaperone Lispro U-100
Injection of BioChaperone Lispro U-200
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
AUCLisp (0-inf)
Area under the insulin lispro serum concentration - time curve from t=0 to infinity
Time frame: 8 hours
Cmax Lisp
Maximum observed insulin lispro serum concentration
Time frame: 8 hours
tmax Lisp
Time to maximum observed serum insulin lispro concentration
Time frame: 8 hours
AUCGIR(0-8h)
Area under the glucose infusion rate-time curve from t=0 to 8 hours
Time frame: 8 hours
GIRmax
Maximum glucose infusion rate
Time frame: 8 hours
tGIRmax
Time to maximum glucose infusion rate
Time frame: 8 hours
Number of Adverse events
Number of adverse events
Time frame: Up to 9 weeks
Local tolerability
Record of injection site reaction
Time frame: Up to 9 weeks
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