Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 4, 2015
Last verified: February 2015

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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence of adverse drug reactions (ADRs) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from the baseline in HbA1c to the last-observation on treatment [ Time Frame: up to 156 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 3300
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 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


Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01650259

  Show 587 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT01650259     History of Changes
Other Study ID Numbers: 1218.95
Study First Received: July 24, 2012
Last Updated: February 4, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on March 01, 2015