| Trial ID: | L2287 |
| Source ID: | NCT01916174
|
| Associated Drug: |
Insulin Degludec/Liraglutide
|
| Title: |
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: insulin degludec/liraglutide|DRUG: insulin degludec/liraglutide
|
| Outcome Measures: |
Primary: Area under the serum IDeg concentration time curve after single dose, Assessed from 0 to 120 hours|Maximum observed serum IDeg concentration after single dose, Assessed from 0-120 hours|Area under the plasma liraglutide concentration time curve after single dose, Assessed from 0-72 hours|Maximum observed plasma liraglutide concentration after single dose, Assessed from 0-72 hours | Secondary: Area under the serum IDeg concentration time curve after single dose, Assessed from 0-120 hours|Time to maximum IDeg concentration, Assessed from 0-120 hours|Terminal elimination half-life for IDeg after single dose, Assessed from 0-120 hours|Area under the plasma liraglutide concentration time curve after single dose, Assessed from 0-72 hours|Time to maximum plasma liraglutide concentration after single dose, Assessed from 0-72 hours|Terminal elimination half-life of liraglutide after single dose, Assessed from 0-72 hours
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-08
|
| Completion Date: |
2013-11
|
| Results First Posted: |
|
| Last Update Posted: |
2013-11-08
|
| Locations: |
Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01916174
|
