Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5824
Source ID: NCT03292185
Associated Drug: Insulin Degludec/Liraglutide
Title: A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/liraglutide|DRUG: insulin degludec|DRUG: liraglutide
Outcome Measures: Primary: Area under the serum insulin degludec concentration time curve, Calculated based on insulin degludec concentration in serum, From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours|Area under the plasma liraglutide concentration time curve, Calculated based on liraglutide concentration in plasma, from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours | Secondary: Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose, Calculated based on insulin degludec measured in serum, 0 hours to 120 hours|Maximum observed serum insulin degludec concentration, Calculated based on insulin degludec measured in serum, 0 hours to 120 hours|Time to maximum serum insulin degludec concentration, Calculated based on insulin degludec measured in serum, 0 hours to 120 hours|Terminal elimination half-life for insulin degludec, Calculated based on insulin degludec measured in serum, 0 hours to 120 hours|Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose, Calculated based on liraglutide measured in plasma, 0 hours to 72 hours|Maximum observed plasma liraglutide concentration, Calculated based on liraglutide measured in plasma, 0 hours to 72 hours|Time to maximum plasma liraglutide concentration, Calculated based on liraglutide measured in plasma, 0 hours to 72 hours|Terminal elimination half-life of liraglutide, Calculated based on liraglutide measured in plasma, 0 hours to 72 hours|Number of treatment emergent adverse events, Count, Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)|Number of treatment emergent hypoglycaemic episodes, Count, Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)|Local tolerability at the injection site, Count, Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-09-29
Completion Date: 2018-01-02
Results First Posted:
Last Update Posted: 2019-11-18
Locations: Novo Nordisk Investigational Site, Beijing, Beijing, 100032, China
URL: https://clinicaltrials.gov/show/NCT03292185