| Trial ID: | L6763 |
| Source ID: | NCT01686945
|
| Associated Drug: |
Semaglutide
|
| Title: |
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: semaglutide|DRUG: semaglutide|DRUG: semaglutide|DRUG: placebo|DRUG: placebo
|
| Outcome Measures: |
Primary: Number of treatment emergent adverse events (TEAEs) recorded, From the time of first dosing and until completion of the post treatment follow-up visits (Day 90 to 104) | Secondary: Area under the plasma concentration curve over the dosing interval (0-24 hours), After the last 3 daily doses for semaglutide and carrier|Change from baseline in fasting plasma glucose (FPG), Week 0, week 10 (Day 69)|Change from baseline in C-peptide, Week 0, week 10 (Day 69)|Change from baseline in insulin, Week 0, week 10 (Day 69)|Change from baseline in glucagon, Week 0, week 10 (Day 69)|Change from baseline in glycosylated haemoglobin type A1c (HbA1c), Week 0, week 10 (Day 69)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
107
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-09-19
|
| Completion Date: |
2013-04-08
|
| Results First Posted: |
|
| Last Update Posted: |
2019-01-04
|
| Locations: |
Novo Nordisk Investigational Site, Berlin, 14050, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01686945
|
