Type1 Diabetes Mellitus Clinical Trial
Official title:
A Euglycaemic Clamp Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of a Bolus Dose of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® by an Insulin Pump
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.
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