PMS of Trazenta on the Long-term Use as Add-on Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Boehringer Ingelheim
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 8, 2013
Last updated: March 4, 2015
Last verified: March 2015

In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by Japanese Pharmaceutical Affairs Low (J-PAL). New ingredient is 8 years for reexamination. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).

Condition Intervention
Diabetes Mellitus, Type 2
Drug: Trazenta

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint to assess safety of Trazenta Tablets is the number (%) of patients with drug related adverse events [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of serious adverse events (SAEs) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of cardiovascular events [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
  • The change between baseline and observation period in Haemoglobin A1c (HbA1c) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: July 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Trazenta Drug: Trazenta
1 tablet of 5 mg Trazenta tablets once daily


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

3000 patients with type 2 Diabetes Mellitus


Inclusion criteria:

Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.

Exclusion criteria:


  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01904383

Contact: Boehringer Ingelheim Call Center 1-800-243-0127

  Show 602 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT01904383     History of Changes
Other Study ID Numbers: 1218.147
Study First Received: July 8, 2013
Last Updated: March 4, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on March 30, 2015