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Clinical Trial Details

Trial ID: L3523
Source ID: NCT03444467
Associated Drug: Nnc9204-1513
Title: First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: DRUG: NNC9204-1513|DRUG: Glucagon|DRUG: Placebo
Outcome Measures: Primary: Number of treatment emergent adverse events (TEAEs), Count of events, from time of dosing (day 1) to completion of the safety follow-up visit (day 8) | Secondary: Change from baseline in haematology, baseline (day 1), follow-up visit (day 8)|Change from baseline in biochemistry, baseline (day 1), follow-up visit (day 8)|Change from baseline in fibrinogen, measured in g/L, baseline (day 1), follow-up visit (day 8)|Change from baseline in lipids, baseline (day 1), follow-up visit (day 8)|Change from baseline in glucose metabolism, baseline (day 1), follow-up visit (day 8)|Change from baseline in hormones, baseline (day 1), follow-up visit (day 8)|Change from baseline in urine dipstick parameter, baseline (day 1), follow-up visit (day 8)|Change from baseline in systolic- and diastolic blood pressure, Measured in mm Hg, baseline (day 1), follow-up visit (day 8)|Change from baseline in body temperature, baseline (day 1), follow-up visit (day 8)|Change from baseline in respiration rate, baseline (day 1), follow-up visit (day 8)|Change from baseline in 12-lead electrocardiogram (ECG) heart rate, baseline (day 1), follow-up visit (day 8)|Change from baseline in 12-lead ECG (RR interval), baseline (day 1), follow-up visit (day 8)|Change from baseline in 12-lead ECG (PR interval), baseline (day 1), follow-up visit (day 8)|Change from baseline in 12-lead ECG (QRS interval), baseline (day 1), follow-up visit (day 8)|Change from baseline in 12-lead ECG (QT interval), baseline (day 1), follow-up visit (day 8)|Change from baseline in 12-lead ECG (QTc intervals [Fridericia]), QT interval corrected for heart rate by Fridericia's formula, baseline (day 1), follow-up visit (day 8)|Change from baseline in Physical examination, baseline (day 1), follow-up visit (day 8)|Incidence of injection site reactions, After administration of the trial products (day 1) until completion of the post-treatment follow-up visit (day 8).|AUC0-15min,SD, area under the plasma concentration time curve, 0 to 15 minutes after single dose|t1/2,SD, terminal half-life, Measured for 24 hours after administration of a single s.c. dose|Onset of appearance, Time from trial product administration until first time plasma concentration ≥ lower limit of quantification (LLOQ), Measured for 24 hours after administration of a single s.c. dose|AUCPG,0-15min,SD, area under the plasma glucose time curve, 0 to 15 minutes after single dose|ΔPG0-15min,SD, Increase in plasma glucose concentration from 0 to 15 minutes, Calculated as: Plasma glucose concentration at 15 minutes after single dose minus plasma glucose concentration at 0 minute, 0 to 15 minutes after single dose|Change from baseline in 12-lead ECG (overall evaluation), baseline (day 1), follow-up visit (day 8)|Change from baseline in prothrombin time, measured in seconds, baseline (day 1), follow-up visit (day 8)|Change from baseline in Activated Partial Thromboplastin time (APTT), measured in seconds, baseline (day 1), follow-up visit (day 8)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-02-05
Completion Date: 2018-05-24
Results First Posted:
Last Update Posted: 2018-09-05
Locations: Novo Nordisk Investigational Site, Berlin, 10117, Germany
URL: https://clinicaltrials.gov/show/NCT03444467