A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump
A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered 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.
Inclusion Criteria:

 -  Type 1 Diabetes Mellitus for more than 12 months.

 -  BMI between 18.5 and 28.5 kg/m².

 -  HbA1C level <=9.0%.

 -  Insulin treated for at least 12 months with total insulin dose <1.2U/kg/day.

 Exclusion Criteria:

 -  Type 2 Diabetes Mellitus.

 -  History of multiple and/or severe allergies to drugs or foods.

 -  Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory,
 gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of
 conditions associated with diabetes mellitus), haematological, dermatological,
 neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic
 (if female), or infectious disease, or signs of acute illness as judged by the
 Investigator.

 -  More than one episode of severe hypoglycaemia with seizure, coma or requiring
 assistance of another person during the past 6 months.

 -  Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular
 autonomic neuropathy.

 -  Females of childbearing potential, who are pregnant, breast-feeding or intend to
 become pregnant or are not using highly effective contraceptive methods.