A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
NCT ID: NCT03176524
Last Updated: 2017-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2017-06-06
2017-09-04
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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BioChaperone® glucagon formulation 1
Single subcutaneous fixed doses (50 µg and 1.0 mg)
BioChaperone® glucagon formulation 1
Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg
BioChaperone® glucagon formulation 2
Single subcutaneous fixed doses (50 µg and 1.0 mg)
BioChaperone® glucagon formulation 2
Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg
GlucaGen® HypoKit®
Single subcutaneous fixed doses (50 µg and 1.0 mg)
GlucaGen® HypoKit®
Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg
Interventions
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BioChaperone® glucagon formulation 1
Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg
BioChaperone® glucagon formulation 2
Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg
GlucaGen® HypoKit®
Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
* Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
* Stable insulin treatment at least 3 months prior to the screening visit
* Stable disease with HbA1c \<9.0 %
* C peptide \<=0.30 nmol/L
* Body mass index (BMI) \< 30.0 kg/m2
Exclusion Criteria
* Previous participation in this trial. Participation is defined as being randomised
* Receipt of any medicinal product in clinical development within 60 days prior to this trial
* Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator considering the underlying disease
* Known or suspected hypersensitivity to the trial products or related products
* Severe hypoglycaemic events within one month prior to screening, as judged by the investigator
* Recent administration of glucagon (within 3 months prior to Screening)
* Clinically relevant diabetic complications as judged by the investigator
* Women of child bearing potential not willing to use contraceptive methods
18 Years
64 Years
ALL
No
Sponsors
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Adocia
INDUSTRY
Responsible Party
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Principal Investigators
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Ulrike Hövelmann, MD
Role: PRINCIPAL_INVESTIGATOR
Profil Institut für Stoffwechselforschung GmbH
Locations
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Profil Institut für Stoffwechselforschung GmbH
Neuss, , Germany
Countries
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Other Identifiers
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BC13-CT028
Identifier Type: -
Identifier Source: org_study_id
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