This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus. Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal. Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal. The total trial duration for an individual subject will be up to 11 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake
Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake
Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake
Profil Mainz GmbH & Co.KG
Mainz, Germany
Profil GmbH
Neuss, Germany
BG1h
Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal
Time frame: 1 hour
ΔBG1h
Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal
Time frame: 1 hour
AUCBG,0-1h
Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal
Time frame: 1 hour
ΔAUCBG,0-1h
Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal
Time frame: 1 hour
AUCIns,0-1h
Area under the serum insulin concentration-time curve from 0-1 hour
Time frame: 1 hour
Adverse Events
Number of Adverse Events
Time frame: Up to 11 weeks
Local tolerability (Number of injection site reactions)
Number of injection site reactions
Time frame: Up to 11 weeks
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