| Trial ID: | L1970 |
| Source ID: | NCT01272973
|
| Associated Drug: |
Semaglutide
|
| Title: |
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: semaglutide|DRUG: placebo|DRUG: semaglutide
|
| Outcome Measures: |
Primary: Frequency of adverse events (AEs), from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose | Secondary: Hypoglycaemic episodes, from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose|Laboratory safety variables (haematology, biochemistry, and urinalysis), from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose|Maximum plasma concentration of NN9924, after dosing on the 68th, 69th and 70th Day|Area under the plasma concentration curve over the dosing interval (0-24 hours), after dosing on the 68th, 69th and 70th day|Terminal phase elimination half-life, from last dose (day 70) to follow-up visit 91-105 days after first dose
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
96
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-01
|
| Completion Date: |
2011-07
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-23
|
| Locations: |
Berlin, 14050, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01272973
|
