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

This study is ongoing, but not recruiting participants.
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: July 24, 2012
Last updated: February 24, 2017
Last verified: February 2017
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 Intervention
Diabetes Mellitus, Type 2
Drug: OAD
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 in Patients With Type 2 Diabetes Mellitus

Further study details as provided by Boehringer Ingelheim:

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

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

Enrollment: 4554
Study Start Date: July 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oral antidiabetic drug (OAD) Drug: OAD
OAD except Trazenta tablets
Trazenta Drug: Trazenta


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01650259

  Show 352 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT01650259     History of Changes
Other Study ID Numbers: 1218.95
Study First Received: July 24, 2012
Last Updated: February 24, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 25, 2017