| Trial ID: | L1862 |
| Source ID: | NCT01866748
|
| Associated Drug: |
Semaglutide
|
| Title: |
Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: semaglutide|DRUG: semaglutide|DRUG: placebo|DRUG: placebo
|
| Outcome Measures: |
Primary: Part A: Number of treatment emergent adverse events (TEAEs), Day -1 to Day 24|Part B: Number of treatment emergent adverse events (TEAEs), Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104) | Secondary: Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve, From time 0 to 24 hours after a single dose (Day 0)|Part B: AUCĪ,semaglutide: area under the semaglutide plasma concentration curve, Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69)|Part B: Change in fasting plasma glucose (FPG) from baseline, Day 0 (pre-dose), day 70|Part B: Change in body weight from baseline, Day -1, day 70
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
170
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-05
|
| Completion Date: |
2014-04
|
| Results First Posted: |
|
| Last Update Posted: |
2014-04-28
|
| Locations: |
Berlin, 14050, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01866748
|
