| Trial ID: | L3508 |
| Source ID: | NCT01516255
|
| Associated Drug: |
Liraglutide
|
| Title: |
Effect of Liraglutide on Heart Frequency in Healthy Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: liraglutide|DRUG: placebo|DRUG: moxifloxacin|DRUG: placebo|PROCEDURE: electrocardiogram (ECG)|PROCEDURE: electrocardiogram (ECG)
|
| Outcome Measures: |
Primary: Maximum time-matched mean difference between the baseline subtracted QTci intervals | Secondary: QTc at liraglutide tmax (time to reach maximum concentration)|Percentage subjects with QTc at least 450, 480 and 500 milliseconds|Moxifloxacin maximum time-matched mean change QTc and QTci|Cmax, maximum concentration of liraglutide|tmax, time to reach Cmax of liraglutide|Vitals signs: Blood pressure|Vital signs: Pulse|Serial electrocardiography
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-07
|
| Completion Date: |
2006-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-25
|
| Locations: |
Novo Nordisk Investigational Site, Fargo, North Dakota, 58104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01516255
|