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

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ClinicalTrials.gov Identifier: NCT01650259
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

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 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
Primary Completion Date : September 5, 2017
Study Completion Date : September 5, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Incidence of adverse drug reactions (ADRs) [ Time Frame: up to 156 weeks ]

Secondary Outcome Measures :
  1. The change from the baseline in HbA1c to the last-observation on treatment [ Time Frame: up to 156 weeks ]


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
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:


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
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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01650259     History of Changes
Other Study ID Numbers: 1218.95
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

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