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

Boehringer Ingelheim logo

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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