| Trial ID: | L7050 |
| Source ID: | NCT01707147
|
| Associated Drug: |
Trajenta Tablet
|
| Title: |
A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01707147/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Trajenta tablet
|
| Outcome Measures: |
Primary: Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta, Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta., Up to 26 weeks (long-term surveillance) | Secondary: Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c), Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c)., Baseline and Week 24|Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment, Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of \< 6.5% after 24 weeks of treatment., 24 Weeks|Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment), Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment)., 24 Weeks|Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG), Change from baseline after 24 weeks in fasting plasma glucose (FPG)., Baseline and Week 24
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
3219
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2012-11-16
|
| Completion Date: |
2017-07-11
|
| Results First Posted: |
2019-01-11
|
| Last Update Posted: |
2019-01-11
|
| Locations: |
Multiple Locations, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01707147
|
