| Trial ID: | L6554 |
| Source ID: | NCT03144271
|
| Associated Drug: |
Semaglutide
|
| Title: |
Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: semaglutide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of Adverse Events, After 24-33 days | Secondary: Area under the curve of NNC 0113-0217, From 0-48 hours after dosing|Area under the curve of NNC 0113-0217, From 0-168 hours after dosing|Morning fasting plasma glucose, At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19)|Morning fasting insulin, At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19)|Morning fasting glucagon, At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
58
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-06-11
|
| Completion Date: |
2007-10-08
|
| Results First Posted: |
|
| Last Update Posted: |
2017-05-08
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03144271
|
