Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01650259
Last Updated: 2019-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
4876 participants
OBSERVATIONAL
2012-07-23
2017-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Oral antidiabetic drug (OAD)
OAD
OAD except Trazenta tablets
Trazenta
Trazenta
Linagliptin
Interventions
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OAD
OAD except Trazenta tablets
Trazenta
Linagliptin
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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One Or Multiple Locations, , Japan
Countries
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1218.95
Identifier Type: -
Identifier Source: org_study_id
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