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Clinical Trial Details

Trial ID: L2176
Source ID: NCT04569994
Associated Drug: Nnc0363-0845
Title: A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Healthy Volunteers|Diabetes Mellitus, Type 1
Interventions: DRUG: NNC0363-0845|DRUG: Placebo (NNC0363-0845)|DRUG: Insulin degludec
Outcome Measures: Primary: Number of treatment-emergent adverse events (AEs), Number of events, Part 1 and 2: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10|Number of treatment-emergent adverse events (AEs), Number of events, Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1) | Secondary: Number of treatment-emergent hypoglycaemic episodes, Number of episodes, Part 1 and 2 From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 6, day 10|Number of treatment-emergent hypoglycaemic episodes, Number of episodes, Part 3: From trial product administration at Visit 2, day 1 until completion of post treatment end-of-trial visit at Visit 4 (up to 33 days after Visit 2, day 1)|Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose, pmol\*h/L, Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)|Area under the serum NNC0363-0845 concentration-time curve from 0 to infinity after a single dose, pmol\*h/L, Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)|Maximum observed serum NNC0363-0845 concentration after a single dose, pmol/L, Part 1 and 2 From 0 hours until last measurement time after trial product administration (Visit 2, day 1)|Maximum observed serum NNC0363-0845 concentration after a single dose, pmol/L, Part 3: From 0 hours until last measurement time after trial product administration (Visit 2, day 1 and Visit 3, day 1)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 68
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-09-30
Completion Date: 2021-06-23
Results First Posted:
Last Update Posted: 2023-06-27
Locations: Novo Nordisk Investigational Site, Mainz, 55116, Germany
URL: https://clinicaltrials.gov/show/NCT04569994