A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in Korea

Boehringer Ingelheim

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Trajenta duo

Study type: Observational

Funder types: Industry

Identifiers

NCT01903356

1288.22

Details and patient eligibility

About

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.

Full description

Study Design:

Post Marketed Study- Observational study

Enrollment: 724 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Potential subjets must meet all of the following inclusion criteria to enter this trial:

1. No previous exposure to Trajenta, Trajenta Duo
2. Should have been started on Trajenta Duo in accordance with the approved label in Korea
3. No current participation in clinical trials
4. No metformin is inappropriate due to contraindications
5. Must sign on the data release consent form

Exclusion criteria

Individuals with any of the following characteristics will not be able to enter this study:

1. Previous exposure to Trajenta, Trajenta Duo
2. Current participation in clinical trials
3. Patients for whom metformin is inappropriate due to contraindications

Trial design

724 participants in 1 patient group

Patients with T2DM

Treatment:

Drug: Trajenta duo