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Clinical Trial Details

Trial ID: L7261
Source ID: NCT01473953
Associated Drug: Liraglutide-Depot
Title: Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01473953/results
Conditions: Diabetes|Diabetes Mellitus, Type 2|Healthy
Interventions: DRUG: liraglutide-depot|DRUG: placebo
Outcome Measures: Primary: Number of Treatment Emergent Adverse Events (TEAEs), TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect., Day 0 and up to 21 days after treatment | Secondary: Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot, Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot, Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity, Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment, 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose|Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment, 0 to 168 hours after dosing|Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up, Day 0 and Day 21
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 31
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-10
Completion Date: 2012-03
Results First Posted: 2013-09-04
Last Update Posted: 2017-03-23
Locations: Novo Nordisk Investigational Site, Evansville, Indiana, 47710, United States
URL: https://clinicaltrials.gov/show/NCT01473953