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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioChaperone® glucagon formulation 1 | Experimental | Single subcutaneous fixed doses (50 µg and 1.0 mg) |
|
| BioChaperone® glucagon formulation 2 | Experimental | Single subcutaneous fixed doses (50 µg and 1.0 mg) |
|
| GlucaGen® HypoKit® | Active Comparator | Single subcutaneous fixed doses (50 µg and 1.0 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioChaperone® glucagon formulation 1 | Drug | Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 10 weeks |
| Physical examination | Examination of the body systems | 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) | 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) | Up to 10 weeks |
| Adverse events and serious adverse events | Untoward medical occurrence | Up to 10 weeks |
| Assessments of local tolerability at injection site | Local reaction at injection site | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUCPK 0-30min | area under the baseline adjusted plasma glucagon concentration curve from 0 to 30 min | From 0 to 30 min |
| AUC PK 0-4h | area under the baseline adjusted plasma glucagon concentration curve from 0 to 4 h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Hövelmann, MD | Profil Institut für Stoffwechselforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
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| BioChaperone® glucagon formulation 2 | Drug | Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg |
|
| GlucaGen® HypoKit® | Drug | Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg |
|
| From 0 to 4 hours |
| ΔAUCPG 0-30min | area under the baseline adjusted plasma glucose curve from 0 until 30 min | From 0 to 30 min |
| ΔAUCPG 0-4h | area under the baseline adjusted plasma glucose curve from 0 until 4h | From 0 to 4 hours |
| ΔPG 30min | baseline adjusted plasma glucose concentration at 30 min | 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 | 30 min after drug administration |
| Time to plasma glucose increase of ≥20 mg/dL from baseline | only at day 2 | Up to 4 hours after drug administration |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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