This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®, each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits. Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD) assessments will be carried until 4 hours. Safety will be assessed during all the trial period. The total trial maximum duration for the individual subject will be up to 10 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg
Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg
Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Clinical safety laboratory
Haematology, biochemistry and urinalysis: changes or findings from baseline in clinical safety laboratory parameters during the trial duration (screening visit, treatment visits and follow up visit)
Time frame: Up to 10 weeks
Physical examination
Examination of the body systems
Time frame: Up to 10 weeks
ECG parameters
Heart rate, PQ, QRS, QT, QTcB: changes or findings from baseline in ECG parameters during the trial duration (screening visit, treatment visits and follow up visit)
Time frame: Up to 10 weeks
Vital signs
Diastolic and systolic blood pressure (mmHg), Pulse (beats/min), Body temperature (°C), Respiratory frequency (RF/min): changes or findings from baseline in vital signs during the trial duration (screening visit, treatment visits and follow up visit)
Time frame: Up to 10 weeks
Adverse events and serious adverse events
Untoward medical occurrence
Time frame: Up to 10 weeks
Assessments of local tolerability at injection site
Local reaction at injection site
Time frame: Up to 10 weeks
AUCPK 0-30min
area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min
Time frame: From 0 to 30 min
AUC PK 0-4h
area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h
Time frame: From 0 to 4 hours
ΔAUCPG 0-30min
area under the baseline adjusted plasma glucose curve from 0 until 30 min
Time frame: From 0 to 30 min
ΔAUCPG 0-4h
area under the baseline adjusted plasma glucose curve from 0 until 4h
Time frame: From 0 to 4 hours
ΔPG 30min
baseline adjusted plasma glucose concentration at 30 min
Time frame: From 0 to 30 min
Percentage of patients achieving a plasma glucose increase of ≥20 mg/dL from baseline within 30 minutes after treatment
only at day 2
Time frame: 30 min after drug administration
Time to plasma glucose increase of ≥20 mg/dL from baseline
only at day 2
Time frame: Up to 4 hours after drug administration
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