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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|ClinicalTrials.gov Identifier: NCT01903356|
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : December 21, 2018
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Drug: Trajenta duo|
Post Marketed Study- Observational study
|Study Type :||Observational|
|Actual Enrollment :||724 participants|
|Official Title:||A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta Duo® (Linagliptin/Metformin HCl, 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg, b.i.d) in Korean Patients With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||July 11, 2013|
|Actual Primary Completion Date :||May 30, 2017|
|Actual Study Completion Date :||June 10, 2017|
|Patients with T2DM||
Drug: Trajenta duo
Linagliptin and Metformin
- Incidence Rate of Adverse Events (AE) [ Time Frame: Up to 26 weeks ]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
- Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment. [ Time Frame: Baseline and Week 24 ]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.
- Target Effectiveness Response Rate [ Time Frame: 24 Weeks ]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.
- Relative Effectiveness Response Rate [ Time Frame: 24 Weeks ]Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks.
- Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment. [ Time Frame: 24 Weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903356
|Korea, Republic of|
|Multiple Locations, Korea, Republic of|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|