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

NCT ID: NCT01650259

Last Updated: 2019-09-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4876 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-23

Study Completion Date

2017-09-14

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral antidiabetic drug (OAD)

OAD

Intervention Type DRUG

OAD except Trazenta tablets

Trazenta

Trazenta

Intervention Type DRUG

Linagliptin

Interventions

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OAD

OAD except Trazenta tablets

Intervention Type DRUG

Trazenta

Linagliptin

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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One Or Multiple Locations, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 35418260 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31933070 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31713160 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1218.95

Identifier Type: -

Identifier Source: org_study_id

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