Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal \[(t=0 min) start of the meal\]. Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home in the evening before each dosing visit. Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
Subcutaneous injection of an individualized dose
Subcutaneous injection of an individualized dose
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Delta AUCBG,0-2h
Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal
Time frame: 2 hours
Delta AUCBG,0-6h
Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal
Time frame: 6 hours
BGmax
Maximum blood glucose concentration after a standardised meal (0-6 hours)
Time frame: 6 hours
tBGmax
Time to maximum blood glucose concentration after a standardised meal (0-6 hours)
Time frame: 6 hours
AUCLisp,0-6h,
Area under the plasma insulin lispro concentration-time curve from 0-6 hours
Time frame: 6 hours
AUCGlarg,0-6h
Area under the plasma insulin glargine concentration-time curve from 0-6 hours
Time frame: 6 hours
Cmax,Lisp
Maximum observed plasma insulin lispro concentration
Time frame: 6 hours
Cmax,Glarg
Maximum observed plasma insulin glargine concentration
Time frame: 6 hours
Adverse events
Number of adverse events
Time frame: Up to 7 weeks
Local tolerability
Number and intensity of injection site reactions
Time frame: Up to 7 weeks
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