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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01904383
First Posted: July 22, 2013
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
July 8, 2013
July 22, 2013
November 13, 2017
July 1, 2013
September 30, 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 ]
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 ]
  • Incidence of cardiovascular events [ Time Frame: up to 156 weeks ]
  • The change between baseline and observation period in Haemoglobin A1c (HbA1c) [ Time Frame: up to 156 weeks ]
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
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.
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.
 
Active, not recruiting
4058
September 30, 2018
September 30, 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:

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
Japan
 
NCT01904383
1218.147
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2017