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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 10, 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
  Purpose
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.

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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4058
Actual Study Start Date: July 1, 2013
Estimated Study Completion Date: September 30, 2018
Estimated Primary Completion Date: September 30, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
3000 patients with type 2 Diabetes Mellitus
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904383


Locations
Germany
CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites
Ingelheim am Rhein, Germany, 55216
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01904383     History of Changes
Other Study ID Numbers: 1218.147
First Submitted: July 8, 2013
First Posted: July 22, 2013
Last Update Posted: November 10, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases