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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 2, 2013
Last verified: May 2013
History of Changes

July 24, 2012
May 2, 2013
July 2012
July 2017   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01650259 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Post Marketing Surveillance of Trazenta on the Long-term Use
Post Marketing Survey on Long Term Drug Use of Trazenta Tablets in Patients With Type 2 Diabetes Mellitus

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

3300
Diabetes Mellitus, Type 2
  • Drug: OAD
    OAD except Trazenta tablets
  • Drug: Trazenta
    Linagliptin
  • Oral antidiabetic drug (OAD)
    Intervention: Drug: OAD
  • Trazenta
    Intervention: Drug: Trazenta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3300
July 2017
July 2017   (final data collection date for primary outcome measure)

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
Both
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No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Japan
 
NCT01650259
1218.95
Not Provided
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP