Status:

COMPLETED

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

Lead Sponsor:

Boehringer Ingelheim

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

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

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Potential subjets must meet all of the following inclusion criteria to enter this trial:
  • No previous exposure to Trajenta, Trajenta Duo
  • Should have been started on Trajenta Duo in accordance with the approved label in Korea
  • No current participation in clinical trials
  • No metformin is inappropriate due to contraindications
  • 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:
  • Previous exposure to Trajenta, Trajenta Duo
  • Current participation in clinical trials
  • Patients for whom metformin is inappropriate due to contraindications

Exclusion

    Key Trial Info

    Start Date :

    July 11 2013

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    June 10 2017

    Estimated Enrollment :

    724 Patients enrolled

    Trial Details

    Trial ID

    NCT01903356

    Start Date

    July 11 2013

    End Date

    June 10 2017

    Last Update

    December 21 2018

    Active Locations (1)

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    Multiple Locations, South Korea