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Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus

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: NCT01650259
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : May 10, 2019
Last Update Posted : September 18, 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 monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: OAD Drug: Trazenta

Study Design
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Study Type : Observational
Actual Enrollment : 4876 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : July 23, 2012
Actual Primary Completion Date : September 5, 2017
Actual Study Completion Date : September 14, 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Oral antidiabetic drug (OAD) Drug: OAD
OAD except Trazenta tablets
Trazenta Drug: Trazenta
Linagliptin


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Adverse Drug Reactions (ADRs) [ Time Frame: From start of the treatment until the end of this PMS, i.e. up to week 156 ]
    An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as "Yes", "Probably yes" or "Can't be denied".


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at the Last Observation During the Observation Period. [ Time Frame: Baseline and 156 week or last observation ]
    Change from baseline in Haemoglobin A1c (HbA1c) at the last observation during the observation period is presented as mean change from baseline and standard deviation (SD).


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
3300
Criteria

Inclusion criteria:

  • Male and female patients with type 2 Diabetes Mellitus who have never been treated with Trazenta tablets / Linagliptin (monotherapy) before enrollment. (Trazenta group)
  • Patients with type 2 Diabetes Mellitus starting any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug (OAD)) except Trazenta tablets. (OAD group)

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): NCT01650259


Locations
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Japan
One Or 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] April 4, 2013
Statistical Analysis Plan  [PDF] November 14, 2017

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: NCT01650259    
Other Study ID Numbers: 1218.95
First Posted: July 26, 2012    Key Record Dates
Results First Posted: May 10, 2019
Last Update Posted: September 18, 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