This is a single-centre, randomised, double-blind, 4-way crossover, 4-treatment, euglycaemic clamp study in subjects with Type 1 Diabetes Mellitus (T1DM). Each subject will be randomly allocated to one of four treatment sequences. Each sequence comprises one single dose of each of four IMPs. IMP1 and IMP2 are BioChaperone lispro formulations. They have the same composition and correspond to different development stages of a unique product which is BioChaperone insulin lispro; between them, improvements were made to prepare industrial production. Comparators (IMP3 and IMP4) are US-approved Humalog® and EU-approved Humalog®. All IMPs will be dosed at 0.2 U/Kg of insulin lispro on 4 dosing visits separated by a washout period of 5 to 15 days. The trial will compare the characteristics of BioChaperone insulin lispro fully liquid (IMP2) formulation to US-approved Humalog and EU-approved Humalog.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Administration of IMP1 during a 12-hour euglycaemic clamp.
Administration of IMP2 during a 12-hour euglycaemic clamp.
Administration of IMP3 during a 12-hour euglycaemic clamp.
Administration of IMP4 during a 12-hour euglycaemic clamp.
Profil GmbH
Mainz, Germany
AUCGIR.0-12h
Area under the glucose infusion rate-time curve from time 0 until end of clamp
Time frame: From t=0 to t=12 hours after IMP administration
AUCGIR.0-1h
Area under the glucose infusion rate-time curve from time 0 to 1 hour after IMP administration
Time frame: From t=0 to t=1 hour after IMP administration
AUCLIS.0-12h
Area under the insulin lispro concentration-time curve from 0 hours to 12 hours after dose administration
Time frame: From t=0 to t=12 hours after IMP administration
AUCLIS.0-1h
Area under the insulin lispro concentration-time curve from 0 hours to 1 hour after dose administration
Time frame: From t=0 to t=1 hour after IMP administration
tmax.LIS
Time to maximum observed insulin lispro concentration
Time frame: From t=0 to t=12 hours after IMP administration
Cmax.LIS
Maximum observed insulin lispro concentration
Time frame: From t=0 to t=12 hours after IMP administration
AUCLIS.2-6h
Area under the insulin lispro concentration-time curve from 2 hour to 6 hour after dose administration
Time frame: From t=2 to t=6hours after IMP administration
t50%-LIS (early)
Time to half-maximum before Cmax.LIS
Time frame: From t=0 to t=12 hours after IMP administration
tmax.GIR
Time to maximum glucose infusion rate
Time frame: From t=0 to t=12 hours after IMP administration
GIRmax
Maximum glucose infusion rate
Time frame: From t=0 to t=12 hours after IMP administration
AUCGIR.4-8h
Area under the glucose infusion rate-time curve from 4 to 8 hours after dose administration
Time frame: From t=4 to t=8 hours after IMP administration
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