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Clinical Trial Details

Trial ID: L5202
Source ID: NCT04655690
Associated Drug: Nnc0471-0119
Title: A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: NNC0471-0119|DRUG: Fast-acting insulin aspart
Outcome Measures: Primary: Number of adverse events (AEs), Number of events, From investigational medicinal product (IMP) administration at day 1 (Visit 2) and up to 22 days post IMP administration (Visit 3) | Secondary: Number of hypoglycaemic episodes, Number of episodes, 0 to 24 hours after IMP administration|AUCNNC0471-0119,0-30 min/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 0-30 min and 0-t, where t is the last observed time point with insulin concentration above lower limit of quantification (LLOQ)., % (Percent), 0 to 12 hours after IMP administration|AUCNNC0471-0119,2h-t/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 2 hours to t and 0 to t, where t is the last observed time point with insulin concentration above LLOQ., 0 to 12 hours after IMP administration|AUCNNC0471-0119, 0-t: Area under the serum NNC0471-0119 concentration-time curve from 0 to t, where t is the last observed time point with insulin concentration above LLOQ., h\*pmol/L, 0 to 12 hours after IMP administration|Cmax,NNC0471-0119: Maximum observed serum NNC0471- 0119 concentration, pmol/L, 0 to 12 hours after IMP administration|tmax,NNC0471-0119: Time to maximum observed serum NNC0471-0119 concentration, Minutes, 0 to 12 hours after IMP administration|t½, NNC0471-0119: Terminal half-life for NNC0471-0119, Minutes, 0 to 12 hours after IMP administration
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-11-09
Completion Date: 2021-11-26
Results First Posted:
Last Update Posted: 2023-01-03
Locations: Novo Nordisk Investigational Site, Graz, 8010, Austria
URL: https://clinicaltrials.gov/show/NCT04655690