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Clinical Trial Details

Trial ID: L5352
Source ID: NCT03723759
Associated Drug: Faster Aspart 200 U/Ml
Title: A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Faster Aspart 200 U/mL|DRUG: Faster aspart 100 U/mL
Outcome Measures: Primary: AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure, Measured in pmol\*h/L, 0 to 10 hours after IMP administration | Secondary: AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration, Measured in pmol\*h/L, 0 to 1 hour after IMP administration|AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration, Measured in pmol\*h/L, 0 to 2 hours after IMP administration|AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity, Measured in pmol\*h/L, 0 to 10 hours after IMP administration|Cmax,IAsp - Maximum observed serum insulin aspart concentration, Measured in pmol/L, 0 to 10 hours after IMP administration|tmax,IAsp - Time to maximum observed serum insulin aspart concentration, Measured in minutes, 0 to 10 hours after IMP administration|Number of adverse events in the treatment emergent period, Count of events, 0 to 2 days after IMP administration|Number of local reactions at the injection site in the treatment emergent period, Count of injection site reactions, 0 to 2 days after IMP administration|Number of hypoglycaemic episodes in the treatment emergent period, Count of hypoglycaemic episodes, 0 to 16 hours after IMP administration
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 56
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-10-26
Completion Date: 2019-03-27
Results First Posted:
Last Update Posted: 2020-03-18
Locations: Novo Nordisk Investigational Site, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT03723759