This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight. Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
AUCGIR(0-60min)
Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration
Time frame: 60 minutes
AUCins(0-30min)
Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration
Time frame: 30 minutes
AUCins(0-60min)
Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration
Time frame: 60 minutes
AUCins(0-600min)
Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration
Time frame: 600 minutes
Cmax insulin
Maximum observed baseline corrected insulin concentration
Time frame: 10 hours
Tmax insulin
Time from bolus administration to baseline corrected Cmax
Time frame: 10 hours
TmaxGIR
Time from bolus administration to maximum baseline corrected glucose infusion rate
Time frame: 10 hours
GIRmax
Maximum baseline corrected glucose infusion rate
Time frame: 10 hours
Adverse Events
Number of Adverse Events in each arm
Time frame: up to 8 weeks
Clinical safety laboratory
Haematology, biochemistry and urinalysis: changes and findings from Baseline in clinical safety laboratory parameters during the trial duration, from screening, and at follow-up visit.
Time frame: up to 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.