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Clinical Trial Details

Trial ID: L4212
Source ID: NCT03176524
Associated Drug: Biochaperone® Glucagon Formulation 1
Title: A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: BioChaperone® glucagon formulation 1|DRUG: BioChaperone® glucagon formulation 2|DRUG: GlucaGen® HypoKit®
Outcome Measures: Primary: 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 | Secondary: 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, 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
Sponsor/Collaborators: Sponsor: Adocia
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 27
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-06-06
Completion Date: 2017-09-04
Results First Posted:
Last Update Posted: 2017-12-12
Locations: Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT03176524