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Post Marketing Surveillance of Trazenta on the Long-term Use

This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01650259
First received: July 24, 2012
Last updated: May 29, 2013
Last verified: May 2013
History of Changes
  Purpose

In Japan, post-approval execution of post-marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for re-examination. Reexamination period is defined by the J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of re-examination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare.


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 Survey on Long Term Drug Use of Trazenta Tablets in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Secondary Outcome Measures:
  • The change between baseline and observation period in HbA1c [ Time Frame: up to 156 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse drug reactions (ADRs) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of cardiovascular events [ Time Frame: up to 156 weeks ] [ Designated as safety issue: Yes ]

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
Linagliptin

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650259

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 582 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01650259     History of Changes
Other Study ID Numbers: 1218.95
Study First Received: July 24, 2012
Last Updated: May 29, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on June 17, 2013