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

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.
 
ClinicalTrials.gov Identifier: NCT01904383
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Trazenta

Study Design
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Study Type : Observational
Actual Enrollment : 4057 participants
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
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Trazenta Drug: Trazenta
1 tablet of 5 mg Trazenta tablets once daily


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Drug Related Adverse Events [ Time Frame: From first drug administration until last drug administration, up to approximately 156 weeks. ]
    Percentage of participants with drug related adverse events.


Secondary Outcome Measures :
  1. The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c) [ Time Frame: Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks. ]
    The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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:

None

Contacts and Locations
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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
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] June 7, 2013
Statistical Analysis Plan  [PDF] October 12, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01904383    
Other Study ID Numbers: 1218.147
First Posted: July 22, 2013    Key Record Dates
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases