This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits. Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments. During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Injection of BioChaperone® Combo
Injection of Humalog® Mix25
Injection of Humalog®
Profil Mainz GmbH & Co.KG
Mainz, Germany
Profil GmbH
Neuss, Germany
Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)
Mean of incremental areas under the blood glucose concentration-time curve from 0-2 hours after a standardised meal on Day 2 and Day 3
Time frame: From 0 to 2 hours
Partial delta AUCs BG and total AUCs BG
Partial incremental AUCs BG and total AUCs BG in the 0-6 time range
Time frame: From 0 to 6 hours
Mean and mean change from baseline of blood glucose at different time points
Time frame: From 0 to 6 hours
Delta BGmax and delta BGmin
Maximum and minimum blood glucose excursions after a standardised meal
Time frame: From 0 to 6 hours
BGmax and BGmin
Maximum and minimum blood glucose concentrations after a standardised meal
Time frame: From 0 to 6 hours
AUC Insulin
Partial areas under the insulins plasma concentration time curve
Time frame: From 0 to 24 hours
Cmax Insulin
Maximum observed plasma insulins concentration
Time frame: From 0 to 6 hours
tmax Insulin
Time to maximum observed plasma insulins concentration
Time frame: From 0 to 6 hours
Adverse Events
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Injection of Lantus®
Injection of 0.9% NaCl
Time frame: Up to 12 weeks (maximum duration of subject's participation)
Local tolerability
Time frame: Up to 12 weeks (maximum duration of subject's participation)
Hypoglycaemic events
Time frame: Up to 12 weeks (maximum duration of subject's participation)