| Trial ID: | L5163 |
| Source ID: | NCT01809184
|
| Associated Drug: |
Insulin 287
|
| Title: |
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin 287|DRUG: insulin glargine|DRUG: placebo
|
| Outcome Measures: |
Primary: Number of adverse events (AEs), As recorded from trial product administration and until completion of Sub-visit 2G (Day 13) | Secondary: Area under the serum insulin concentration-time curve, From 0 to 648 hours after a single dose|Area under the glucose infusion rate (GIR)-time curve, From 0 to 24 hours after a single dose
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
84
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-03-04
|
| Completion Date: |
2013-09-06
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-01
|
| Locations: |
Novo Nordisk Investigational Site, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01809184
|