Clinical trial NCT03179332: A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type1 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: AUCGIR(0-60min)
timeFrame: 60 minutes
Secondary outcomes:
measure: AUCins(0-30min)
timeFrame: 30 minutes
measure: AUCins(0-60min)
timeFrame: 60 minutes
measure: AUCins(0-600min)
timeFrame: 600 minutes
measure: Cmax insulin
timeFrame: 10 hours
measure: Tmax insulin
timeFrame: 10 hours
measure: TmaxGIR
timeFrame: 10 hours
measure: GIRmax
timeFrame: 10 hours
measure: Adverse Events
timeFrame: up to 8 weeks
measure: Clinical safety laboratory
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Oliver Klein, MD
role: PRINCIPAL_INVESTIGATOR
References: