| Trial ID: | L3370 |
| Source ID: | NCT02479022
|
| Associated Drug: |
Insulin 320
|
| Title: |
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: Insulin 320|DRUG: insulin glargine|DRUG: placebo
|
| Outcome Measures: |
Primary: Number of treatment-emergent adverse events, From the time of trial product administration and until 12 days after trial product administration | Secondary: Area under the serum insulin concentration-time curve, From 0 to 288 hours after a single dose (SD)|Area under the glucose infusion rate-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: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-06
|
| Completion Date: |
2015-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-08-01
|
| Locations: |
Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02479022
|
