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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01904383
First received: July 8, 2013
Last updated: October 16, 2014
Last verified: October 2014

July 8, 2013
October 16, 2014
July 2013
June 2018   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01904383 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
PMS of Trazenta on the Long-term Use as Add-on Therapy
Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

3000 patients with type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2
Drug: Trazenta
1 tablet of 5 mg Trazenta tablets once daily
Trazenta
Intervention: Drug: Trazenta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
June 2018
June 2018   (final data collection date for primary outcome measure)

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:

None

Both
Not Provided
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Japan
 
NCT01904383
1218.147
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP