| Trial ID: | L5791 |
| Source ID: | NCT01903356
|
| Associated Drug: |
Trajenta Duo
|
| Title: |
A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01903356/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Trajenta duo
|
| Outcome Measures: |
Primary: Incidence Rate of Adverse Events (AE), The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo, Up to 26 weeks | Secondary: Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment., This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range., Baseline and Week 24|Target Effectiveness Response Rate, Occurrence of treatment to target effectiveness response is an HbA1c under treatment of \< 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c \< 6.5% after 24 weeks., 24 Weeks|Relative Effectiveness Response Rate, Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks., 24 Weeks|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment., This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication., 24 Weeks
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
724
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2013-07-11
|
| Completion Date: |
2017-06-10
|
| Results First Posted: |
2018-12-21
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| Last Update Posted: |
2018-12-21
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| Locations: |
Multiple Locations, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01903356
|
