| Trial ID: | L2920 |
| Source ID: | NCT01984372
|
| Associated Drug: |
Insulin Degludec
|
| Title: |
Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin degludec
|
| Outcome Measures: |
Primary: Incidence of AEs (Adverse Events) by preferred term, During 3 years of treatment | Secondary: Incidence of AEs (Adverse Events) by preferred term, During 6 months of treatment|Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term, During 6 months of treatment|Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term, During 3 years of treatment|Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term, During 6 months of treatment|Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term, During 3 years of treatment|Incidence of severe hypoglycaemia, During 6 months of treatment|Incidence of severe hypoglycaemia, During 3 years of treatment
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
6163
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2013-11-06
|
| Completion Date: |
2019-04-30
|
| Results First Posted: |
|
| Last Update Posted: |
2020-08-04
|
| Locations: |
Novo Nordisk Investigational Site, Tokyo, 1000005, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT01984372
|
