NCT01903356CompletedNot Applicable
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 724
- Primary Endpoint
- Incidence Rate of Adverse Events (AE)
Study Overview
Brief Summary
The primary objective of this study is to monitor the safety profile of Trajenta Duo in Korean patients with type 2 diabetes mellitus (T2DM) in a routine clinical setting.
Detailed Description
Study Design:
Post Marketed Study- Observational study
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Patients with T2DM
Intervention: Trajenta duo (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Relative Effectiveness Response Rate(24 Weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.(24 Weeks)
- Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.(Baseline and Week 24)
- Target Effectiveness Response Rate(24 Weeks)
Investigators
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