NCT01650259

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,876

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 10, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

5.1 years

First QC Date

July 24, 2012

Results QC Date

August 20, 2018

Last Update Submit

September 3, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Adverse Drug Reactions (ADRs)

    An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as "Yes", "Probably yes" or "Can't be denied".

    From start of the treatment until the end of this PMS, i.e. up to week 156

Secondary Outcomes (1)

  • Change From Baseline in HbA1c at the Last Observation During the Observation Period.

    Baseline and 156 week or last observation

Study Arms (2)

Oral antidiabetic drug (OAD)

Drug: OAD

Trazenta

Drug: Trazenta

Interventions

OADDRUG

OAD except Trazenta tablets

Oral antidiabetic drug (OAD)
TrazentaDRUG

Linagliptin

Trazenta

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

3300

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

One Or Multiple Locations, Japan

Location

Related Publications (3)

  • Yabe D, Yamamoto F, Lund SS, Okamura T, Kadowaki T. Long-term safety and effectiveness of linagliptin by baseline body mass index in Japanese patients with type 2 diabetes: a 3-year post-marketing surveillance study. Expert Opin Drug Saf. 2022 Oct;21(10):1303-1313. doi: 10.1080/14740338.2022.2057948. Epub 2022 May 3.

    PMID: 35418260DERIVED

  • Yamamoto F, Ikeda R, Ochiai K, Hirase T, Hayashi N, Okamura T. Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes and Renal Dysfunction: a Post-Marketing Surveillance Study. Diabetes Ther. 2020 Feb;11(2):523-533. doi: 10.1007/s13300-019-00754-4. Epub 2020 Jan 13.

    PMID: 31933070DERIVED

  • Yamamoto F, Unno Y, Okamura T, Ikeda R, Ochiai K, Hayashi N. Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes Mellitus: A 3-Year Post-Marketing Surveillance Study. Diabetes Ther. 2020 Jan;11(1):107-117. doi: 10.1007/s13300-019-00723-x. Epub 2019 Nov 11.

    PMID: 31713160DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.

Results Point of Contact

Title
Boehringer Ingelheim, Call Centre
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 26, 2012

Study Start

July 23, 2012

Primary Completion

September 5, 2017

Study Completion

September 14, 2017

Last Updated

September 18, 2019

Results First Posted

May 10, 2019

Record last verified: 2019-09

Locations

JP(1)