| Trial ID: | L5111 |
| Source ID: | NCT02146079
|
| Associated Drug: |
Semaglutide
|
| Title: |
A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: semaglutide|DRUG: placebo
|
| Outcome Measures: |
Primary: Area under the plasma semaglutide concentration-time curve, During a dosing interval (0-168 hours) at steady state | Secondary: Maximum observed plasma semaglutide concentration at steady state, 0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)|Change in body weight from baseline to the end of treatment, Day 1 of Visit 2 (2-21 days after Visit 1), Day 92|Number of treatment emergent adverse events (TEAEs) from baseline to follow-up, From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-05-21
|
| Completion Date: |
2014-10-20
|
| Results First Posted: |
|
| Last Update Posted: |
2018-04-18
|
| Locations: |
Novo Nordisk Investigational Site, Tokyo, 130-0004, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT02146079
|
